A Mixed-Methods Protocol to Explore Psychological Distress and Psychosocial Needs Along the Continuum of CKD Care— A Single Healthcare Network

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As the disease progresses, patients often experience a significant decline in quality of life (QoL), driven by disease-related symptoms and the burden of renal replacement therapies (RRT) such as dialysis and transplantation. In addition to physical symptoms, up to 55% of patients report psychological distress, including depression and anxiety. Despite this, mental health needs are frequently under-identified and insufficiently addressed in nephrology care. There is limited understanding of how patients experience and cope with this distress, how staff perceive their role in responding to it, and how healthcare environments support or hinder psychosocial care. This study seeks to address these gaps within a single integrated nephrology care network. Methods: This explanatory sequential mixed-methods study will be conducted in two phases. In the first phase, quantitative data will be collected from 200 patients with CKD and 40–60 nephrology staff members using validated questionnaires assessing psychological distress, anxiety, depression, and QoL. Group comparisons will assess differences across RRT modalities, and association analyses will explore relationships between psychological outcomes and demographic or clinical factors. In the second phase, semi-structured interviews and focus groups with patients and staff will explore experiences of psychological distress and care delivery in greater depth. Thematic analysis will be used for qualitative data. Integration of findings through triangulation will provide a comprehensive understanding of psychosocial needs and inform intervention development. Discussion: This study uses a mixed-methods design to investigate psychosocial needs in CKD care from both patient and provider perspectives. It aims to identify modifiable clinical and organizational factors—such as staff preparedness, referral practices, and systemic barriers—that shape the delivery of mental health support. Findings will inform the development of person-centered interventions and may guide broader models for integrating psychological care into chronic disease management. Status of trial: The study began in June 2024. Participant recruitment and data collection are ongoing and will continue until June 2026. Chronic kidney disease dialysis kidney transplant psychological distress anxiety depression psychosocial support Figures Figure 1 RESEARCH TEAM AND CONTRIBUTIONS Author name, affiliations, past contributions and future contributions Mathilde Paré, MD MSc 1,2 Development of research protocol Writing of the study protocol article Data collection, analysis and writing of research articles MP Norah, Zola, BSc 2,3 Development of research protocol Writing of the study protocol article Data collection, analysis and writing of research articles NZ Laëtitia Coudert, PhD, MA 2 Development of research protocol Revision of the study protocol article Data collection, analysis and revision of research articles LC Julien-Carl Phaneuf, MD 4 Methodological advising Revision of the study protocol article Data analysis and revision of research articles JCP Roxanne Lavallée, BSc 2 Development of research protocol Revision of the study protocol article Data collection, analysis and writing of research articles RL Aude Caplette-Gingras, PhD 5,6 Development of research protocol Revision of the study protocol article Data analysis and revision of research articles ACG Catherine Fortier, PhD 2,7 Development of research protocol Revision of the study protocol article Data analysis and revision of research articles CF Mohsen Agharazii, MD 2,8 Development of research protocol Revision of the study protocol article Data analysis and revision of research articles MA BACKGROUND Globally, chronic kidney disease (CKD) affects 8–16% of the adult population, posing a major public health challenge ( 1 , 2 ). In Canada, approximately 4 million individuals live with CKD ( 3 , 4 ). As CKD progresses, the burden of disease intensifies. Patients with advanced CKD or end-stage kidney disease (ESKD) often experience a significant decline in quality of life, comparable to that observed in other severe chronic illnesses such as cancer and heart failure ( 5 – 10 ). This decline is driven by both the symptoms of the disease and the demands of renal replacement therapies (RRT), in the form of either in-center or home-based hemodialysis, peritoneal dialysis, or kidney transplantation. While these treatments are life-sustaining, they are frequently associated with pain, fatigue, sexual dysfunction, and other debilitating symptoms that impact physical, cognitive, psychological, and social well-being ( 9 , 11 ). Beyond its physical toll, CKD imposes a significant psychological burden, with studies documenting high levels of distress associated with both disease and treatment ( 12 ). Depressive symptoms have been reported in up to 55% of individuals with CKD, and anxiety symptoms in up to 50%, across all treatment modalities ( 11 , 13 , 14 ). Amongst the sources of distress identified thus far, lack of control over the disease and constant awareness of mortality have been identified as psychological and existential distress ( 15 , 16 ). In parallel, studies have shown that patients use various coping strategies focusing on problem resolution and/or emotional regulation that can be adaptive or maladaptive depending on their unique circumstances ( 17 – 19 ). Despite the growing body of evidence documenting these concerns, psychological needs remain insufficiently addressed in routine nephrology care. The availability and accessibility of psychosocial support services vary widely, and integration into standard clinical pathways is often limited. Furthermore, there is limited insight into how healthcare providers perceive their role in identifying and responding to patients’ mental health needs, or how they view existing support within their health care networks. Understanding these perspectives is essential to inform the development of feasible and context-sensitive interventions that are acceptable to both patients and healthcare professionals. Therefore, this mixed-method study seeks to explore the experience of psychological distress among patients with advanced CKD, as well as staff perceptions of mental health care delivery within a single integrated nephrology care network which provides nephrological care to patients who are scattered over a wide geographical territory. Furthermore, it aims to identify the characteristics of the health-care environment that influence the delivery of effective care, by integrating both patient and staff perspectives. By providing an in-depth understanding of psychological distress in CKD patients of our network, this study will lay the groundwork for the development of clinical and organizational interventions aiming to improve the well-being of patients across the different stages of disease and treatment modalities. METHODS/DESIGN Design and method This study employs a two-stage explanatory sequential cross-sectional mixed methods design, beginning with a quantitative study of both patient and staff perspectives through questionnaires and medical records, followed by a more detailed exploration of similar themes through qualitative analysis of individual interview and focus-group data (20). This design was selected to build a detailed understanding of experiences related to CKD in patients from a single care network, but with varied backgrounds, treatment modalities, and geographic dispersion. Quantitative data collection and analysis will be conducted first to identify patterns in patients’ and healthcare providers’ experiences of disease management, treatment burden, and psychosocial support. These findings will then inform the qualitative phase, which will seek to explore underlying mechanisms and contextual factors through in-depth interviews. This design is deemed particularly appropriate given the study’s objective to generate a comprehensive understanding of care needs and system-level influences, while remaining feasible within a cross-sectional framework. It also supports the development of person-centered interventions by integrating measurable trends with nuanced experiential data. This work constitutes the foundational phase of a broader research program guided by the Picker Principles of Person-Centered Care and the United Kingdom Medical Research Council (UKMRC) Framework for Developing and Evaluating Complex Interventions, two frameworks that emphasize stakeholder engagement and the importance of grounding interventions in the lived realities of patients and the operational context of care delivery. Research questions Main research question : What are the psychological support needs of patients with advanced CKD, and how can these needs be effectively addressed within an integrated care model? Specific research questions centered on patients as participants Quantitative research questions 1. Does the level of psychological distress, anxiety, depression, and quality of life differ significantly across renal replacement therapy modalities? 2. What clinical, demographic, and social characteristics are associated with psychological distress and quality of life in CKD patients Qualitative research questions 1. How do patients with CKD describe their day-to-day experience of living with the disease, particularly in relation to their psychological well-being? 2. How did patients with CKD experience the psychological or emotional support they received—or the absence of such support—along their care trajectory? 3. What do patients perceive as essential for promoting their well-being within their healthcare environment? Specific research questions centered on staff as participants Quantitative research questions 1. To what extent do staff perceptions, levels of satisfaction, and perceived preparedness regarding the provision of psychosocial support to CKD patients differ according to professional role, mental health training, years of experience, and frequency of patient contact? 2. What clinical and structural resources do staff find most useful for identifying and addressing psychological distress in patients with CKD? Qualitative research questions 1. How do healthcare and administrative staff perceive the psychological needs of patients with CKD in their care? 2. What experience do staff have with providing or facilitating support for patients’ psychological well-being? Setting The study will be conducted within the CHU de Québec-Université Laval, the City of Québec’s network of teaching hospitals. This hospital network is the reference center for nephrology for the Eastern part of the province of Quebec, Canada, serving 2 million people, with a prevalent patient population of 500 pre-dialysis CKD patients, 1200 patients having received a kidney transplant and 300 hemodialysis and 90 home dialysis patients. While most patients treated at the institution are Caucasian French-Canadians, a significant minority of patients are from indigenous communities, and a smaller proportion from other ethnic or linguistic minorities. The nephrology service multidisciplinary team is composed of nephrology unit nursing staff, specialized clinic nursing staff, pharmacists, dieticians, social workers, staff nephrologists, nephrology fellows (i.e. nephrologists pursuing additional training), nephrology trainees, administrative personnel, and hospital coordinators. Study population and sampling Patients Patients with CKD will be recruited based on their current treatment modality, categorized as follows: (1) pre-dialysis CKD, (2) in-center hemodialysis, (3) home dialysis (including both peritoneal and home hemodialysis), and (4) kidney transplantation. A total of 200 patients —50 from each treatment group—will be recruited for the quantitative component of the study using standardized questionnaires. From this sample, 20 to 25 participants will be purposively selected to take part in individual semi-structured interviews exploring their lived experiences. Eligible patient participants are adults (≥18 years) with CKD, defined as an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m² or as having received a kidney transplant. The choice of eGFR cut-off was made, as stage 3 CKD with eGFR < 60 patients mL/min/1.73m² has been associated with increased cardiovascular mortality and hospitalization, (21) as well as more frequent follow-ups, blood works and an increasing number of medications. Patients will be excluded if they are unable to provide informed consent or to complete study questionnaires due to cognitive, emotional, or language limitations, even with the assistance of research staff, an interpreter, or an Indigenous liaison officer. Recruitment will follow a quota-based convenience sampling strategy, with equal numbers of participants recruited from each treatment group to ensure balanced comparisons. Eligible patients will be approached consecutively during routine nephrology clinic visits. Initial contact will be made by a clinic staff member, after which interested patients will be referred to the research team for informed consent. Participants may complete the questionnaires on-site or take them home to allow time for reflection before contacting the research team to enroll or with additional questions. Staff All clinical and administrative nephrology staff are eligible to participate, regardless of job title. Staff recruitment will follow a proportionate stratified sampling approach, ensuring representation of professional roles in accordance with their relative size within the nephrology workforce. The project will be introduced to staff of different job titles by their coordinator or a research team member (RL, NZ), either directly in clinical settings or through email. Consent forms and questionnaires will be distributed in that same way, with information on how to return them should they wish to participate (22). Samples size calculation Quantitative sample · Patients As suggested in the mixed-methods literature, a sample size of 30 participants per group is generally sufficient to allow for regression analyses based on questionnaire data (23, 24). Sample size analysis shows that a total sample size of 200 patients (4 groups of 50 cases) ensures an 84% power for the F-test of ANOVA to detect a moderate effect size of f = 0.25 with an alpha error of 0.05. · Nephrology staff Given the survey nature of the staff questionnaire and the fact that it has not been externally validated, a minimal sample size of N=40 staff members has been agreed upon based on similar designs within the literature. Given the accessibility of staff members and their numbers, it is likely that between 40 and 60 participants will be recruited. Qualitative sample · Patients Sample size will be guided by the principle of data saturation, the point at which no new thematic insights emerge with additional data collection (25, 26). Given the expected diversity of experiences across disease stages and treatment modalities, we plan to include approximately 20–25 patients living with CKD in individual interviews. Individual interviews were chosen to allow participants to share personal information relative to their mental health without being concerned about other participants’ judgment or confidentiality. · Nephrology staff Profession-specific focus groups will be conducted amongst nephrology staff to enhance homogeneity and allow for deeper, role-specific discussion grounded in shared clinical realities. Focus groups were chosen to facilitate the co-construction of ideas and maximize participation in clinical contexts where time is scarce. We anticipate conducting 1 focus group per professional subgroup (e.g., nurses, physicians), each including 5–8 participants. Individual interviews will also be offered for health care professionals who are unable to participate in a focus-group session or for those from professional subgroups with limited numbers of participants (e.g., fewer than 3 individuals such as nutritionists and social workers). When appropriate, these participants could also be integrated into interprofessional focus groups. This decision will be based on logistical considerations and participant preferences, while ensuring the integrity of the data collection process. Instruments Quantitative Data Collection During the initial study visit, all participating patients will complete a battery of questionnaires, either self-administered or with assistance from research staff, depending on individual needs. · General Information Questionnaire (GIQ): This questionnaire was adapted from a tool developed by Taylor et al. (2016) as part of a mixed-methods protocol exploring psychological and emotional support needs in end-stage renal disease and published in BMJ Open under a CC BY 4.0 license (27). It assesses distress, psychosocial concerns, and perceived support within the healthcare setting. The translated and adapted version is presented in Supplemental file A. Using a tailored questionnaire enhances contextual relevance while maintaining continuity with previously validated constructs. · Kidney Disease Quality of Life Instrument (KDQOL): The KDQOL is a well-validated disease-specific measure developed to assess health-related quality of life in individuals with CKD and those receiving dialysis (28). It incorporates both general and kidney-specific domains. This questionnaire will be administered to all patient participants, including those with a kidney transplant, to allow for cross-group comparisons. · Hospital Anxiety and Depression Scale (HADS): The HADS is a 14-item instrument that measures symptoms of anxiety and depression and is particularly suitable for use in medically ill populations, as it minimizes confounding by physical symptoms (29). It has been extensively validated in patients with chronic illnesses, including CKD. · Distress Thermometer (DT): The DT is a brief screening tool that assesses overall psychological distress and includes a checklist of common contributing issues (physical, emotional, social). It has been widely validated across chronic disease populations and is recommended by the National Comprehensive Cancer Network (30). · Renal Transplant Questionnaire, Version 2 (RTQ-V2): The RTQ-V2 is a transplant-specific quality of life instrument validated in kidney transplant populations (31). It assesses unique concerns related to immunosuppression, graft function, and transplant-related lifestyle factors. This instrument will be administered only to patients who have received a kidney transplant, in addition to the KDQOL. Relevant clinical data (e.g., dialysis initiation date, hemoglobin levels, comorbidities, medications) will be extracted from patient medical records. Nephrology staff will be invited to complete the Clinical and Administrative Staff Questionnaire (CASQ), adapted from Taylor et al. (2016) (27). This questionnaire assesses staff perceptions of psychological distress among patients with CKD, as well as unmet psychosocial needs and barriers for patients to access appropriate mental health support, in line with the study’s research questions. Its methodological properties are presented in the original article. Using this tool will enable meaningful comparisons across settings and contribute to its refinement based on the findings of this study’s mixed-methods design. The final French version of the questionnaire is provided in supplemental file B. Additionally, relevant demographic and clinical data will be extracted from patients’ electronic medical records to help identify potential determinants of psychological distress and well-being among individuals with CKD. Variables to be examined will include the nature and number of comorbid medical conditions, as well as key biological parameters such as hemoglobin levels, acid-base balance, and markers of uremia. Psychiatric history and current use of psychoactive medications will also be considered covariates. Finally, dialysis-related variables—including dialysis vintage, history of previous renal replacement therapy modalities, and prior kidney transplant loss—will be included in the analysis. Qualitative Data Collection Qualitative data will be collected through individual semi-structured interviews and profession-based focus groups. · Individual semi-structured interviews are expected to last between 50 and 75 minutes. However, no time limit will be imposed on participants. They will be allowed to terminate the discussion at any time. Should the discussion topics start to become redundant, the interviewer will lead the discussion to an end. The interview guide is provided in supplemental file C. · Focus groups with staff participants are expected to last between 90-120 minutes, and interviews between 60-75 minutes. No time limit will be imposed on participants. When discussion topics have been sufficiently explored, the moderator or participants will suggest adjourning the meeting. They will be led by a trained moderator, while another research team member will observe and collect information pertaining to non-verbal communication. The focus-group and semi-structured interview guides are provided in supplemental file D. Data analysis Quantitative data analysis Statistical analyses will provide a description of distress and well-being scores measured using quantitative questionnaires (GIQ, KDQoL, HADS, DT, RTQ-V2) from patients with kidney disease. These analyses will determine whether differences exist between subgroups of kidney disease patients and examine the effect of various underlying sociodemographic and clinical factors. Statistical analyses will be conducted using SAS Statistical Software v.9.4 (SAS Institute, Cary, NC, USA), Distress and well-being scores, as well as other continuous variables, will be presented as means, standard deviations, 95% confidence intervals, medians, and interquartile ranges. ANOVA (or Kruskal-Wallis) with subsequent t-test (or Mann-Whitney U test) will be used to assess differences across categories of renal replacement therapy. Categorical variables will be described using frequencies and percentages. Chi-square or Fisher’s exact tests will be used to assess differences across categories of renal replacement therapy. Associations between distress and well-being scores, and socio-demographical, clinical parameters will be explored using univariate and multivariate regression models. Tukey-Kramer adjustment will be applied for multiple comparisons. A two-tailed p-value of < 0.05 is considered statistically significant. Qualitative data analysis Data from the semi-structured interviews and focus groups will be analyzed using thematic analysis, following the approach outlined by Braun and Clarke (32). Recordings will be transcribed and coded both manually and using NVivo (QSR International Pty Ltd., Melbourne, Australia) to support data management. Analysis will continue until thematic saturation is reached, that is, when no new themes emerge from the data. Data interpretation and integration This is a cross-language study which will be conducted in French, using questionnaires that have either been validated for use in French speakers, or in-house questionnaires developed by Quebec French-speaking research staff. Data will be disseminated locally in French, but to broader audiences in English (articles, conferences). Recognizing that translation is an interpretive act that can affect meaning, we will ensure that data are initially analyzed in the original language (coding and thematic analysis) to preserve linguistic and cultural nuance. Key quotations will be translated by bilingual team members, with translator annotations to contextualize culturally specific terms or concepts. When possible, collaborative review will be employed to enhance interpretive fidelity. This approach aims to maintain the authenticity of participants’ voices while ensuring clarity and coherence in reporting for an international audience (33-35). Quantitative and qualitative findings will be integrated during the interpretation phase to provide a comprehensive understanding of psychological distress in patients with chronic kidney disease and the perspectives of nephrology staff. Both data strands will be given equal weight in the analysis. Triangulation will be used to identify points of convergence, divergence, and complementarity between questionnaire results and interview or focus group themes. This approach ensures that statistical patterns are enriched by contextual and experiential insights, thereby informing the development of person-centered interventions grounded in both empirical trends and lived realities (20). DISCUSSION This study will employ a sequential explanatory mixed methods design to explore psychological distress among patients with advanced CKD and to understand how mental health care is perceived and addressed by nephrology staff. By integrating quantitative data on distress prevalence, anxiety, depression, and quality of life with qualitative insights into the lived experience of patients and the perspectives of staff, this study will provide a comprehensive understanding of psychological needs within a single integrated nephrology care network (20). The study is innovative in its dual focus: it will assess the extent of psychological distress experienced by patients while also exploring systemic and professional-level factors that shape the capacity to address this distress in practice. High levels of psychological distress, including anxiety and depression, are well documented in individuals with CKD, with prevalence rates reaching 55% across treatment modalities (11, 13, 14). However, psychological needs often remain under-identified and insufficiently addressed in routine nephrology care. This project addresses that gap by incorporating both patient and provider perspectives, which is essential for the design of interventions that are both feasible and contextually appropriate (27). This is one of the first studies in Quebec – a majority French speaking population in Canada- to apply a mixed-methods approach to simultaneously capture both patient and provider experiences with psychosocial aspects of CKD care. It is also among the few that aim to identify modifiable characteristics of the healthcare environment—such as staff preparedness, time constraints, and referral pathways—that influence the integration of mental health care into nephrology services (Fletcher et al., 2022). Findings from this research will contribute to the development of targeted, context-sensitive interventions aimed at improving the identification and management of psychological distress in patients with CKD. These interventions may include validated screening tools enhanced access to psychosocial professionals and strengthened interdisciplinary collaboration. In turn, such improvements could lead to better treatment adherence, increased patient satisfaction, and reduced reliance on acute care services (36, 37). In addition to its clinical impact, this study will advance theoretical understanding in health psychology by contributing to a contextual model of psychological distress in CKD and reinforcing person-centered care models (38). Insights gained may be transferable to other chronic disease populations and inform broader strategies for system-wide transformation in chronic care delivery (39). The use of both quantitative and qualitative methods will enable a more nuanced and holistic interpretation of patient and staff experiences. Triangulation of findings will ensure that numerical trends are complemented and enriched by in-depth narratives, enhancing the validity and utility of the results (20). This balanced integration of data types is critical to ensure that intervention development is grounded not only in prevalence estimates but also in the lived realities of those affected. However, some limitations must be acknowledged. The use of quota-based convenience sampling in the patient population may introduce selection bias, as individuals who access care more frequently or are more engaged in their care may be overrepresented (40). Additionally, while focus groups offer rich data on shared experiences among staff, they may limit disclosure of sensitive or dissenting views (41). Finally, the translation of qualitative data from French to English for publication purposes presents the risk of subtle meaning loss; to mitigate this, bilingual researchers will be involved in translation and review (42, 43). Despite these limitations, this study will generate practical knowledge that can inform the co-design of sustainable, person-centered interventions to better support the mental health and well-being of individuals living with CKD. Abbreviations CASQ Clinical and Administrative Staff Questionnaire CHU Centre Hospitalier Universitaire CHUQ-UL CHU de Québec–Université Laval CKD Chronic Kidney Disease DT Distress Thermometer eGFR Estimated Glomerular Filtration Rate ESKD End-Stage Kidney Disease GIQ General Information Questionnaire HADS Hospital Anxiety and Depression Scale KDQL Kidney Disease Quality of Life Instrument RRT Renal Replacement Therapy RTQ-V2 Renal Transplant Questionnaire, Version 2 UKMRC United Kingdom Medical Research Council Declarations CLINICAL TRIAL NUMBER: Not applicable Ethics approval and consent to participate The Research Ethics Committee of CHU de Québec-Université Laval has approved this study, registered under 2025-6835 and ensures follow-up. The study will be conducted in accordance with the Declaration of Helsinki. Participants will be given full study information and asked to provide written informed consent if they wish to participate. Sequential identification numbers will be attributed to each consenting participant to protect the confidentiality of their information. Only the principal study investigators will have access to the identification key which will be kept on a protected research server. Consent for publication Not applicable Availability of data and materials Not applicable Competing interests None of the research team members have competing interests in relation to this publication. Funding This work is supported by the Fonds de recherche du Québec-Santé (FRQS) through the research centre grant for the CHU de Québec-Université Laval Research Center (reference: 30641), by clinical research grants from the Fondation du CHU de Québec-Université Laval and from the Fédération des médecins résidents du Québec (FMRQ), along with funding from Amgen Canada. CF is supported by the Amgen Research Chair in Nephrology, from the Fondation de l’Université Laval and the Fonds de recherche du Québec – Santé (FRQS, https://doi.org/10.69777/368036). Authors’ contributions MP, NZ, RL, and LC developed the research protocol, with methodological inputs from JCP and ACG. CF and MA revised the study protocol before submission for ethical approval. This study protocol article was written by MP and NZ. All the other authors revised the manuscript. Acknowledgments We would like to acknowledge the contribution of Aline Haaj, Sylvain Iceta, Sacha de Serres, Fabrice Mac-Way, Francesca Taylor and Hélène St-Jacques who have agreed to answer specific methodological questions concerning the research protocol and this manuscript. We would also like to thank the research team members (Lyna Kali, Alice Mailloux, Adrian Felipe Castilla), along with the clinical teams who have supported the beginning of recruitment. References Lv JC, Zhang LX. Prevalence and Disease Burden of Chronic Kidney Disease. Adv Exp Med Biol. 2019;1165:3–15. Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, et al. Chronic kidney disease: global dimension and perspectives. Lancet. 2013;382(9888):260–72. Kitzler TM, Chun J. Understanding the current landscape of kidney disease in Canada to advance precision medicine–guided personalized care. Can J Kidney Health Disease. 2023;10:20543581231154185. Bello AK, Tangri N. Prevalence and demographics of chronic kidney disease in Canadian primary care settings: data from CPCSSN 2010–2015. JAMA Netw Open. 2019;2(10):e1917040. Altintepe L, Levendoglu F, Okudan N, Guney I, Savas Cilli A, Ugurlu H, et al. Physical disability, psychological status, and health-related quality of life in older hemodialysis patients and age-matched controls. Hemodial Int. 2006;10(3):260–6. Belasco A, Barbosa D, Bettencourt AR, Diccini S, Sesso R. Quality of life of family caregivers of elderly patients on hemodialysis and peritoneal dialysis. Am J Kidney Dis. 2006;48(6):955–63. Evans RW, Manninen DL, Garrison LP Jr., Hart LG, Blagg CR, Gutman RA, et al. The quality of life of patients with end-stage renal disease. N Engl J Med. 1985;312(9):553–9. Kurella Tamura M, Covinsky KE, Chertow GM, Yaffe K, Landefeld CS, McCulloch CE. Functional status of elderly adults before and after initiation of dialysis. N Engl J Med. 2009;361(16):1539–47. Solano JP, Gomes B, Higginson IJ. A comparison of symptom prevalence in far advanced cancer, AIDS, heart disease, chronic obstructive pulmonary disease and renal disease. J Pain Symptom Manage. 2006;31(1):58–69. Ulutas O, Farragher J, Chiu E, Cook WL, Jassal SV. Functional Disability in Older Adults Maintained on Peritoneal Dialysis Therapy. Perit Dial Int. 2016;36(1):71–. 8.< . Fletcher BR, Damery S, Aiyegbusi OL, Anderson N, Calvert M, Cockwell P, et al. Symptom burden and health-related quality of life in chronic kidney disease: A global systematic review and meta-analysis. PLoS Med. 2022;19(4):e1003954. Jones DJ, Harvey K, Harris JP, Butler LT, Vaux EC. Understanding the impact of haemodialysis on UK National Health Service patients' well-being: A qualitative investigation. J Clin Nurs. 2018;27(1–2):193–204. Nagy E, Tharwat S, Elsayed AM, Shabaka SAE, Nassar MK. Anxiety and depression in maintenance hemodialysis patients: prevalence and their effects on health-related quality of life. Int Urol Nephrol. 2023;55(11):2905–14. Ye W, Wang L, Wang Y, Wang C, Zeng J. Depression and anxiety symptoms among patients receiving maintenance hemodialysis: a single center cross-sectional study. BMC Nephrol. 2022;23(1):417. Cukor D, Fruchter Y, Ver Halen N, Naidoo S, Patel A, Saggi SJ. Psychological Adaptation to Serious Illness: A Qualitative Study of Advanced CKD Patients of Low Socioeconomic Status. Am J Hospice Palliat Med. 2020;37(1):71–81. Cukor D, Cohen SD, Fruchter Y. Depression and anxiety in chronic kidney disease and ESRD: prevalence, mechanisms, and management strategies. Nephrol Rev. 2019;19(2):132–9. Nair D, Bonnet K, Wild MG, Umeukeje EM, Fissell RB, Faulkner ML, et al. Psychological Adaptation to Serious Illness: A Qualitative Study of Culturally Diverse Patients With Advanced Chronic Kidney Disease. J Pain Symptom Manage. 2021;61(1):32–e412. Schick-Makaroff K, Molzahn AE, Kalfoss M. Symptoms, Coping, and Quality of Life of People with Chronic Kidney Disease. Nephrol Nurs J. 2018;45(4):339–55. Davison SN, Jhangri GS. Existential and supportive care needs among patients with chronic kidney disease. J Pain Symptom Manage. 2010;40(6):838–43. Creswell JW, Plano Clark VL. Designing and Conducting Mixed Methods Research. 3 ed. Thousand Oaks, CA: Sage; 2018. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004;351(13):1296–305. Patton MQ. Qualitative Research & Evaluation Methods. 4 ed. Thousand Oaks, CA: Sage; 2015. Carlsen B, Glenton C. What about N? A methodological study of sample-size reporting in focus group studies. BMC Med Res Methodol. 2011;11:26. Brysbaert M. How Many Participants Do We Have to Include in Properly Powered Experiments? A Tutorial of Power Analysis with Reference Tables. J Cogn. 2019;2(1):16. Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59–82. Krueger RA, Casey MA. Focus Groups: A Practical Guide for Applied Research. 5 ed. Thousand Oaks, CA: Sage; 2015. Taylor F, Taylor C, Baharani J, Nicholas J, Combes G. Integrating emotional and psychological support into the end-stage renal disease pathway: a protocol for mixed methods research to identify patients' lower-level support needs and how these can most effectively be addressed. BMC Nephrol. 2016;17(1):111. Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994;3(5):329–38. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70. Roth AJ, Kornblith AB, Batel-Copel L, Peabody E, Scher HI, Holland JC. Rapid screening for psychologic distress in men with prostate carcinoma: A pilot study. Cancer. 1998;82(10):1904–8. Molzahn AE, Northcott HC, Landeen J. The development and testing of a quality of life questionnaire for renal transplant recipients. Nephrol Nurs J. 1997;24(4):53–60. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Res Psychol. 2006;3(2):77–101. Santos HP Jr., Black AM, Sandelowski M. Timing of translation in cross-language qualitative research. Qual Health Res. 2015;25(1):134–44. van Nes F, Abma T, Jonsson H, Deeg D. Language differences in qualitative research: is meaning lost in translation? Eur J Ageing. 2010;7(4):313–6. Squires A. Methodological challenges in cross-language qualitative research: a research review. Int J Nurs Stud. 2009;46(2):277–87. Fuertes JN, Friedman OB, Moore MT, Rubinstein S. CKD Patients’ Emotional Well–Being: An Examination of Their Psychological Stressors and Support Factors. Kidney Dialysis. 2025;5(2):26. Rivera E, Clark–Cutaia MN, Schrauben SJ, Townsend RR, Lash JP, Hannan M, et al. Treatment Adherence in CKD and Support From Health Care Providers: A Qualitative Study. Kidney Med. 2022;4(11):100545. Picker Institute E. Person-Centred Care: From Ideas to Action. Picker Institute Europe; 2015. Medical Research C. Developing and evaluating complex interventions: new guidance. UK Medical Research Council; 2021. Etikan I, Musa SA, Alkassim RS. Comparison of convenience sampling and purposive sampling. Am J Theoretical Appl Stat. 2016;5(1):1–4. Barbour RS. Doing Focus Groups. London: Sage; 2007. Squires A. Methodological challenges in cross-language qualitative research: A research review. Int J Nurs Stud. 2009;46(2):277–87. van Nes F, Abma T, Jonsson H, Deeg D. Language differences in qualitative research: Is meaning lost in translation? Eur J Ageing. 2010;7(4):313–6. Additional Declarations No competing interests reported. Supplementary Files SUPPLEMENTALFILES.docx Cite Share Download PDF Status: Published Journal Publication published 18 Nov, 2025 Read the published version in BMC Nephrology → Version 1 posted Editorial decision: Revision requested 12 Sep, 2025 Reviews received at journal 12 Sep, 2025 Reviews received at journal 11 Sep, 2025 Reviews received at journal 10 Sep, 2025 Reviewers agreed at journal 05 Sep, 2025 Reviewers agreed at journal 05 Sep, 2025 Reviewers agreed at journal 04 Sep, 2025 Reviewers agreed at journal 02 Sep, 2025 Reviewers invited by journal 02 Sep, 2025 Editor assigned by journal 27 Aug, 2025 Submission checks completed at journal 27 Aug, 2025 First submitted to journal 18 Aug, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7403255","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":511471959,"identity":"dd127138-1023-48ef-967f-cf6c2ad5504c","order_by":0,"name":"Mathilde PARÉ","email":"","orcid":"","institution":"CHU de Québec-Université Laval","correspondingAuthor":false,"prefix":"","firstName":"Mathilde","middleName":"","lastName":"PARÉ","suffix":""},{"id":511471960,"identity":"a5b31f45-c5fc-4d37-bcd9-0da73347fdf6","order_by":1,"name":"Norah ZOLA","email":"","orcid":"","institution":"CHU de Québec-Université Laval Research Center","correspondingAuthor":false,"prefix":"","firstName":"Norah","middleName":"","lastName":"ZOLA","suffix":""},{"id":511471961,"identity":"86f5ae68-24cf-4178-9a3f-aadbe22a8bb6","order_by":2,"name":"Laëtitia COUDERT","email":"","orcid":"","institution":"CHU de Québec-Université Laval Research Center","correspondingAuthor":false,"prefix":"","firstName":"Laëtitia","middleName":"","lastName":"COUDERT","suffix":""},{"id":511471962,"identity":"b99307d3-7f70-4a3b-a93e-6b79cc686259","order_by":3,"name":"Julien-Carl PHANEUF","email":"","orcid":"","institution":"Université Laval","correspondingAuthor":false,"prefix":"","firstName":"Julien-Carl","middleName":"","lastName":"PHANEUF","suffix":""},{"id":511471963,"identity":"8d20ad63-b49e-40b7-864e-32fb8113fce9","order_by":4,"name":"Roxanne LAVALLÉE","email":"","orcid":"","institution":"CHU de Québec-Université Laval Research Center","correspondingAuthor":false,"prefix":"","firstName":"Roxanne","middleName":"","lastName":"LAVALLÉE","suffix":""},{"id":511471964,"identity":"bd60ab9f-68e1-4917-9f8d-99e98bd485b7","order_by":5,"name":"Aude CAPLETTE-GINGRAS","email":"","orcid":"","institution":"CHU de Québec-Université Laval","correspondingAuthor":false,"prefix":"","firstName":"Aude","middleName":"","lastName":"CAPLETTE-GINGRAS","suffix":""},{"id":511471965,"identity":"903433c5-b403-49dd-a012-492f6f2a135e","order_by":6,"name":"Catherine FORTIER","email":"data:image/png;base64,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","orcid":"","institution":"CHU de Québec-Université Laval Research Center","correspondingAuthor":true,"prefix":"","firstName":"Catherine","middleName":"","lastName":"FORTIER","suffix":""},{"id":511471966,"identity":"61b957fd-37ff-4b82-b8a2-fb7c00702d8a","order_by":7,"name":"Mohsen AGHARAZII","email":"","orcid":"","institution":"CHU de Québec-Université Laval Research Center","correspondingAuthor":false,"prefix":"","firstName":"Mohsen","middleName":"","lastName":"AGHARAZII","suffix":""}],"badges":[],"createdAt":"2025-08-19 00:38:18","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7403255/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7403255/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12882-025-04563-9","type":"published","date":"2025-11-18T15:59:01+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":90911736,"identity":"84949f39-dd1a-4db2-95e3-6d313edb875e","added_by":"auto","created_at":"2025-09-09 13:44:10","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":128103,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow diagram illustrating study protocol\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFigure Legend\u003c/strong\u003e: CKD\u0026nbsp;: chronic kidney disease pre-dialysis, HD : hemodialysis, HHD: home hemodialysis, KT: kidney transplant, PD: peritoneal dialysis.\u003c/p\u003e\n\u003cp\u003eDieticians \u003csup\u003e*\u003c/sup\u003e indicates that these participants will be distributed amongst other focus-groups, due to and insufficient number of dieticians amongst the studies health care network.\u003c/p\u003e\n\u003cp\u003eRTQ-V2\u003csup\u003e* \u003c/sup\u003esignifies that this questionnaire does not apply to all participants, but only to KT participants\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7403255/v1/7687249c6c141ea8937f5b3a.png"},{"id":96650229,"identity":"36b4c975-b5cd-4e3d-8714-3e026ee0deba","added_by":"auto","created_at":"2025-11-24 16:10:06","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":989716,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7403255/v1/4dbc4709-327a-49cb-b520-c5fed00fe3ed.pdf"},{"id":90911748,"identity":"9ff3654f-e475-4f16-9e0a-2ea30bbe3f15","added_by":"auto","created_at":"2025-09-09 13:44:10","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":82284,"visible":true,"origin":"","legend":"","description":"","filename":"SUPPLEMENTALFILES.docx","url":"https://assets-eu.researchsquare.com/files/rs-7403255/v1/2900d3e9cb25b4cfa95df47d.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"A Mixed-Methods Protocol to Explore Psychological Distress and Psychosocial Needs Along the Continuum of CKD Care— A Single Healthcare Network","fulltext":[{"header":"RESEARCH TEAM AND CONTRIBUTIONS","content":"\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 583px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAuthor name, affiliations, past contributions and \u003cem\u003efuture contributions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 49px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 583px;\"\u003e\n \u003cp\u003eMathilde Par\u0026eacute;, MD MSc\u003csup\u003e\u0026nbsp;1,2\u003c/sup\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eDevelopment of research protocol\u003c/li\u003e\n \u003cli\u003eWriting of the study protocol article\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eData collection, analysis and writing of research articles\u003c/em\u003e\u0026nbsp;\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 49px;\"\u003e\n \u003cp\u003eMP\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 583px;\"\u003e\n \u003cp\u003eNorah, Zola, BSc\u003csup\u003e\u0026nbsp;2,3\u003c/sup\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eDevelopment of research protocol\u003c/li\u003e\n \u003cli\u003eWriting of the study protocol article\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eData collection, analysis and writing of research articles\u003c/em\u003e\u0026nbsp;\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 49px;\"\u003e\n \u003cp\u003eNZ\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 583px;\"\u003e\n \u003cp\u003eLa\u0026euml;titia Coudert, PhD, MA\u003csup\u003e\u0026nbsp;2\u003c/sup\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eDevelopment of research protocol\u003c/li\u003e\n \u003cli\u003eRevision of the study protocol article\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eData collection, analysis and revision of research articles\u003c/em\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 49px;\"\u003e\n \u003cp\u003eLC\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 583px;\"\u003e\n \u003cp\u003eJulien-Carl Phaneuf, MD\u0026nbsp;\u003csup\u003e4\u003c/sup\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eMethodological advising \u0026nbsp;\u003c/li\u003e\n \u003cli\u003eRevision of the study protocol article\u003c/li\u003e\n \u003c/ul\u003e\n \u003cp\u003e\u003cem\u003eData analysis and revision of research articles\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 49px;\"\u003e\n \u003cp\u003eJCP\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 583px;\"\u003e\n \u003cp\u003eRoxanne Lavall\u0026eacute;e, BSc \u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eDevelopment of research protocol\u003c/li\u003e\n \u003cli\u003eRevision of the study protocol article\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eData collection, analysis and writing of research articles\u003c/em\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 49px;\"\u003e\n \u003cp\u003eRL\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 583px;\"\u003e\n \u003cp\u003eAude Caplette-Gingras, PhD\u003csup\u003e\u0026nbsp;5,6\u003c/sup\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eDevelopment of research protocol\u003c/li\u003e\n \u003cli\u003eRevision of the study protocol article\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eData analysis and revision of research articles\u003c/em\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 49px;\"\u003e\n \u003cp\u003eACG\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 583px;\"\u003e\n \u003cp\u003eCatherine Fortier, PhD\u003csup\u003e\u0026nbsp;2,7\u003c/sup\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eDevelopment of research protocol\u003c/li\u003e\n \u003cli\u003eRevision of the study protocol article\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eData analysis and revision of research articles\u003c/em\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 49px;\"\u003e\n \u003cp\u003eCF\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 583px;\"\u003e\n \u003cp\u003eMohsen Agharazii, MD\u003csup\u003e\u0026nbsp;2,8\u003c/sup\u003e\u003c/p\u003e\n \u003cul\u003e\n \u003cli\u003eDevelopment of research protocol\u003c/li\u003e\n \u003cli\u003eRevision of the study protocol article\u003c/li\u003e\n \u003cli\u003e\u003cem\u003eData analysis and revision of research articles\u003c/em\u003e\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 49px;\"\u003e\n \u003cp\u003eMA\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"BACKGROUND","content":"\u003cp\u003eGlobally, chronic kidney disease (CKD) affects 8\u0026ndash;16% of the adult population, posing a major public health challenge (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). In Canada, approximately 4\u0026nbsp;million individuals live with CKD (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). As CKD progresses, the burden of disease intensifies. Patients with advanced CKD or end-stage kidney disease (ESKD) often experience a significant decline in quality of life, comparable to that observed in other severe chronic illnesses such as cancer and heart failure (\u003cspan additionalcitationids=\"CR6 CR7 CR8 CR9\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). This decline is driven by both the symptoms of the disease and the demands of renal replacement therapies (RRT), in the form of either in-center or home-based hemodialysis, peritoneal dialysis, or kidney transplantation. While these treatments are life-sustaining, they are frequently associated with pain, fatigue, sexual dysfunction, and other debilitating symptoms that impact physical, cognitive, psychological, and social well-being (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eBeyond its physical toll, CKD imposes a significant psychological burden, with studies documenting high levels of distress associated with both disease and treatment (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Depressive symptoms have been reported in up to 55% of individuals with CKD, and anxiety symptoms in up to 50%, across all treatment modalities (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Amongst the sources of distress identified thus far, lack of control over the disease and constant awareness of mortality have been identified as psychological and existential distress (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). In parallel, studies have shown that patients use various coping strategies focusing on problem resolution and/or emotional regulation that can be adaptive or maladaptive depending on their unique circumstances (\u003cspan additionalcitationids=\"CR18\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eDespite the growing body of evidence documenting these concerns, psychological needs remain insufficiently addressed in routine nephrology care. The availability and accessibility of psychosocial support services vary widely, and integration into standard clinical pathways is often limited. Furthermore, there is limited insight into how healthcare providers perceive their role in identifying and responding to patients\u0026rsquo; mental health needs, or how they view existing support within their health care networks. Understanding these perspectives is essential to inform the development of feasible and context-sensitive interventions that are acceptable to both patients and healthcare professionals.\u003c/p\u003e\u003cp\u003eTherefore, this mixed-method study seeks to explore the experience of psychological distress among patients with advanced CKD, as well as staff perceptions of mental health care delivery within a single integrated nephrology care network which provides nephrological care to patients who are scattered over a wide geographical territory. Furthermore, it aims to identify the characteristics of the health-care environment that influence the delivery of effective care, by integrating both patient and staff perspectives. By providing an in-depth understanding of psychological distress in CKD patients of our network, this study will lay the groundwork for the development of clinical and organizational interventions aiming to improve the well-being of patients across the different stages of disease and treatment modalities.\u003c/p\u003e"},{"header":"METHODS/DESIGN","content":"\u003cp\u003e\u003cstrong\u003e\u003cu\u003eDesign and method\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study employs a two-stage explanatory sequential cross-sectional mixed methods design, beginning with a quantitative study of both patient and staff perspectives through questionnaires and medical records, followed by a more detailed exploration of similar themes through qualitative analysis of individual interview and focus-group data (20).\u003c/p\u003e\n\u003cp\u003eThis design was selected to build a detailed understanding of experiences related to CKD in patients from a single care network, but with varied backgrounds, treatment modalities, and geographic dispersion. Quantitative data collection and analysis will be conducted first to identify patterns in patients\u0026rsquo; and healthcare providers\u0026rsquo; experiences of disease management, treatment burden, and psychosocial support. These findings will then inform the qualitative phase, which will seek to explore underlying mechanisms and contextual factors through in-depth interviews. This design is deemed particularly appropriate given the study\u0026rsquo;s objective to generate a comprehensive understanding of care needs and system-level influences, while remaining feasible within a cross-sectional framework. It also supports the development of person-centered interventions by integrating measurable trends with nuanced experiential data.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis work constitutes the foundational phase of a broader research program guided by the Picker Principles of Person-Centered Care and the United Kingdom Medical Research Council (UKMRC) Framework for Developing and Evaluating Complex Interventions, two frameworks that emphasize stakeholder engagement and the importance of grounding interventions in the lived realities of patients and the operational context of care delivery.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eResearch questions\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMain research question\u003c/strong\u003e: What are the psychological support needs of patients with advanced CKD, and how can these needs be effectively addressed within an integrated care model?\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSpecific research questions centered on patients as participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eQuantitative research questions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e1.\u0026nbsp; \u0026nbsp;Does the level of psychological distress, anxiety, depression, and quality of life differ significantly across renal replacement therapy modalities?\u003c/p\u003e\n\u003cp\u003e2.\u0026nbsp; \u0026nbsp;What clinical, demographic, and social characteristics are associated with psychological distress and quality of life in CKD patients\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eQualitative research questions\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e1.\u0026nbsp; \u0026nbsp;How do patients with CKD describe their day-to-day experience of living with the disease, particularly in relation to their psychological well-being?\u003c/p\u003e\n\u003cp\u003e2.\u0026nbsp; \u0026nbsp;How did patients with CKD experience the psychological or emotional support they received\u0026mdash;or the absence of such support\u0026mdash;along their care trajectory?\u003c/p\u003e\n\u003cp\u003e3.\u0026nbsp; \u0026nbsp;What do patients perceive as essential for promoting their well-being within their healthcare environment?\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSpecific research questions centered on staff as participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eQuantitative research questions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e1.\u0026nbsp; \u0026nbsp;To what extent do staff perceptions, levels of satisfaction, and perceived preparedness regarding the provision of psychosocial support to CKD patients differ according to professional role, mental health training, years of experience, and frequency of patient contact?\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e2.\u0026nbsp; \u0026nbsp;\u003c/em\u003eWhat clinical and structural resources do staff find most useful for identifying and addressing psychological distress in patients with CKD?\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eQualitative research questions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e1.\u0026nbsp; \u0026nbsp;How do healthcare and administrative staff perceive the psychological needs of patients with CKD in their care?\u003c/p\u003e\n\u003cp\u003e2.\u0026nbsp; \u0026nbsp;What experience do staff have with providing or facilitating support for patients\u0026rsquo; psychological well-being?\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eSetting\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study will be conducted within the CHU de Qu\u0026eacute;bec-Universit\u0026eacute; Laval, the City of Qu\u0026eacute;bec\u0026rsquo;s network of teaching hospitals. This hospital network is the reference center for nephrology for the Eastern part of the province of Quebec, Canada, serving 2 million people, with a prevalent patient population of 500 pre-dialysis CKD patients, 1200 patients having received a kidney transplant and 300 hemodialysis and 90 home dialysis patients. While most patients treated at the institution are Caucasian French-Canadians, a significant minority of patients are from indigenous communities, and a smaller proportion from other ethnic or linguistic minorities. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe nephrology service multidisciplinary team is composed of nephrology unit nursing staff, specialized clinic nursing staff, pharmacists, dieticians, social workers, staff nephrologists, nephrology fellows (i.e. nephrologists pursuing additional training), nephrology trainees, administrative personnel, and hospital coordinators.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eStudy population and sampling\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatients\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients with CKD will be recruited based on their current treatment modality, categorized as follows: (1) pre-dialysis CKD, (2) in-center hemodialysis, (3) home dialysis (including both peritoneal and home hemodialysis), and (4) kidney transplantation. A total of 200 patients \u0026mdash;50 from each treatment group\u0026mdash;will be recruited for the quantitative component of the study using standardized questionnaires. From this sample, 20 to 25 participants will be purposively selected to take part in individual semi-structured interviews exploring their lived experiences.\u003c/p\u003e\n\u003cp\u003eEligible patient participants are adults (\u0026ge;18 years) with CKD, defined as an estimated glomerular filtration rate (eGFR) \u0026lt; 60 mL/min/1.73m\u0026sup2; or as having received a kidney transplant. The choice of eGFR cut-off was made, as stage 3 CKD with eGFR \u0026lt; 60 patients mL/min/1.73m\u0026sup2; has been associated with increased cardiovascular mortality and hospitalization, \u0026nbsp; (21) as well as more frequent follow-ups, blood works and an increasing number of medications. Patients will be excluded if they are unable to provide informed consent or to complete study questionnaires due to cognitive, emotional, or language limitations, even with the assistance of research staff, an interpreter, or an Indigenous liaison officer.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRecruitment will follow a quota-based convenience sampling strategy, with equal numbers of participants recruited from each treatment group to ensure balanced comparisons. Eligible patients will be approached consecutively during routine nephrology clinic visits. Initial contact will be made by a clinic staff member, after which interested patients will be referred to the research team for informed consent. Participants may complete the questionnaires on-site or take them home to allow time for reflection before contacting the research team to enroll or with additional questions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStaff\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll clinical and administrative nephrology staff are eligible to participate, regardless of job title. Staff recruitment will follow a proportionate stratified sampling approach, ensuring representation of professional roles in accordance with their relative size within the nephrology workforce. The project will be introduced to staff of different job titles by their coordinator or a research team member (RL, NZ), either directly in clinical settings or through email. Consent forms and questionnaires will be distributed in that same way, with information on how to return them should they wish to participate (22).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eSamples size calculation\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuantitative sample\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026middot; \u003cem\u003ePatients\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAs suggested in the mixed-methods literature, a sample size of 30 participants per group is generally sufficient to allow for regression analyses based on questionnaire data (23, 24). Sample size analysis shows that a total sample size of 200 patients (4 groups of 50 cases) ensures an 84% power for the F-test of ANOVA to detect a moderate effect size of f = 0.25 with an alpha error of 0.05.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026middot; \u003cem\u003eNephrology staff\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eGiven the \u003cem\u003esurvey\u0026nbsp;\u003c/em\u003enature of the staff questionnaire and the fact that it has not been externally validated, a minimal sample size of N=40 staff members has been agreed upon based on similar designs within the literature. Given the accessibility of staff members and their numbers, it is likely that between 40 and 60 participants will be recruited.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualitative sample\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026middot; \u003cem\u003ePatients\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSample size will be guided by the principle of data saturation, the point at which no new thematic insights emerge with additional data collection (25, 26). Given the expected diversity of experiences across disease stages and treatment modalities, we plan to include approximately 20\u0026ndash;25 patients living with CKD in individual interviews. Individual interviews were chosen to allow participants to share personal information relative to their mental health without being concerned about other participants\u0026rsquo; judgment or confidentiality. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026middot; \u003cem\u003eNephrology staff\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eProfession-specific focus groups will be conducted amongst nephrology staff to enhance homogeneity and allow for deeper, role-specific discussion grounded in shared clinical realities. \u0026nbsp;Focus groups were chosen to facilitate the co-construction of ideas and maximize participation in clinical contexts where time is scarce. We anticipate conducting 1 focus group per professional subgroup (e.g., nurses, physicians), each including 5\u0026ndash;8 participants. Individual interviews will also be offered for health care professionals who are unable to participate in a focus-group session or for those from professional subgroups with limited numbers of participants (e.g., fewer than 3 individuals such as nutritionists and social workers). When appropriate, these participants could also be integrated into interprofessional focus groups. This decision will be based on logistical considerations and participant preferences, while ensuring the integrity of the data collection process.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eInstruments\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ch4\u003e\u003cstrong\u003eQuantitative Data Collection\u003c/strong\u003e\u003c/h4\u003e\n\u003cp\u003eDuring the initial study visit, all participating patients will complete a battery of questionnaires, either self-administered or with assistance from research staff, depending on individual needs.\u003c/p\u003e\n\u003cp\u003e\u0026middot; \u003cstrong\u003eGeneral Information Questionnaire (GIQ):\u003c/strong\u003e\u003cbr\u003eThis questionnaire was adapted from a tool developed by Taylor et al. (2016) as part of a mixed-methods protocol exploring psychological and emotional support needs in end-stage renal disease and published in \u003cem\u003eBMJ Open\u003c/em\u003e under a CC BY 4.0 license (27). It assesses distress, psychosocial concerns, and perceived support within the healthcare setting. The translated and adapted version is presented in Supplemental file A. Using a tailored questionnaire enhances contextual relevance while maintaining continuity with previously validated constructs.\u003c/p\u003e\n\u003cp\u003e\u0026middot; \u003cstrong\u003eKidney Disease Quality of Life Instrument (KDQOL):\u003c/strong\u003e\u003cbr\u003eThe KDQOL is a well-validated disease-specific measure developed to assess health-related quality of life in individuals with CKD and those receiving dialysis (28). It incorporates both general and kidney-specific domains. This questionnaire will be administered to all patient participants, including those with a kidney transplant, to allow for cross-group comparisons.\u003c/p\u003e\n\u003cp\u003e\u0026middot; \u003cstrong\u003eHospital Anxiety and Depression Scale (HADS):\u003c/strong\u003e\u003cbr\u003eThe HADS is a 14-item instrument that measures symptoms of anxiety and depression and is particularly suitable for use in medically ill populations, as it minimizes confounding by physical symptoms (29). It has been extensively validated in patients with chronic illnesses, including CKD.\u003c/p\u003e\n\u003cp\u003e\u0026middot; \u003cstrong\u003eDistress Thermometer (DT):\u003c/strong\u003e\u003cbr\u003eThe DT is a brief screening tool that assesses overall psychological distress and includes a checklist of common contributing issues (physical, emotional, social). It has been widely validated across chronic disease populations and is recommended by the National Comprehensive Cancer Network (30).\u003c/p\u003e\n\u003cp\u003e\u0026middot; \u003cstrong\u003eRenal Transplant Questionnaire, Version 2 (RTQ-V2):\u003c/strong\u003e\u003cbr\u003eThe RTQ-V2 is a transplant-specific quality of life instrument validated in kidney transplant populations (31). It assesses unique concerns related to immunosuppression, graft function, and transplant-related lifestyle factors. This instrument will be administered only to patients who have received a kidney transplant, in addition to the KDQOL.\u003c/p\u003e\n\u003cp\u003eRelevant clinical data (e.g., dialysis initiation date, hemoglobin levels, comorbidities, medications) will be extracted from patient medical records.\u003c/p\u003e\n\u003cp\u003eNephrology staff will be invited to complete the Clinical and Administrative Staff Questionnaire (CASQ), adapted from Taylor et al. (2016) (27). This questionnaire assesses staff perceptions of psychological distress among patients with CKD, as well as unmet psychosocial needs and barriers for patients to access appropriate mental health support, in line with the study\u0026rsquo;s research questions. Its methodological properties are presented in the original article. Using this tool will enable meaningful comparisons across settings and contribute to its refinement based on the findings of this study\u0026rsquo;s mixed-methods design. The final French version of the questionnaire is provided in supplemental file B.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAdditionally, relevant demographic and clinical data will be extracted from patients\u0026rsquo; electronic medical records to help identify potential determinants of psychological distress and well-being among individuals with CKD. Variables to be examined will include the nature and number of comorbid medical conditions, as well as key biological parameters such as hemoglobin levels, acid-base balance, and markers of uremia. Psychiatric history and current use of psychoactive medications will also be considered covariates. Finally, dialysis-related variables\u0026mdash;including dialysis vintage, history of previous renal replacement therapy modalities, and prior kidney transplant loss\u0026mdash;will be included in the analysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualitative Data Collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eQualitative data will be collected through individual semi-structured interviews and profession-based focus groups.\u003c/p\u003e\n\u003cp\u003e\u0026middot; Individual semi-structured interviews are expected to last between 50 and 75 minutes. However, no time limit will be imposed on participants. They will be allowed to terminate the discussion at any time. Should the discussion topics start to become redundant, the interviewer will lead the discussion to an end. The interview guide is provided in supplemental file C.\u003c/p\u003e\n\u003cp\u003e\u0026middot; Focus groups with staff participants are expected to last between 90-120 minutes, and interviews between 60-75 minutes. No time limit will be imposed on participants. When discussion topics have been sufficiently explored, the moderator or participants will suggest adjourning the meeting. They will be led by a trained moderator, while another research team member will observe and collect information pertaining to non-verbal communication. The focus-group and semi-structured interview guides are provided in supplemental file D.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eData analysis\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuantitative data analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStatistical analyses will provide a description of distress and well-being scores measured using quantitative questionnaires (GIQ, KDQoL, HADS, DT, RTQ-V2) from patients with kidney disease. These analyses will determine whether differences exist between subgroups of kidney disease patients and examine the effect of various underlying sociodemographic and clinical factors. Statistical analyses will be conducted using SAS Statistical Software v.9.4 (SAS Institute, Cary, NC, USA),\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDistress and well-being scores, as well as other continuous variables, will be presented as means, standard deviations, 95% confidence intervals, medians, and interquartile ranges. ANOVA (or Kruskal-Wallis) with subsequent t-test (or Mann-Whitney U test) will be used to assess differences across categories of renal replacement therapy. Categorical variables will be described using frequencies and percentages. Chi-square or Fisher\u0026rsquo;s exact tests will be used to assess differences across categories of renal replacement therapy. Associations between distress and well-being scores, and socio-demographical, clinical parameters will be explored using univariate and multivariate regression models. Tukey-Kramer adjustment will be applied for multiple comparisons. A two-tailed p-value of \u0026lt; 0.05 is considered statistically significant.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualitative data analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData from the semi-structured interviews and focus groups will be analyzed using thematic analysis, following the approach outlined by Braun and Clarke (32). Recordings will be transcribed and coded both manually and using NVivo (QSR International Pty Ltd., Melbourne, Australia) to support data management. Analysis will continue until thematic saturation is reached, that is, when no new themes emerge from the data.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eData interpretation and integration\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is a cross-language study which will be conducted in French, using questionnaires that have either been validated for use in French speakers, or in-house questionnaires developed by Quebec French-speaking research staff. Data will be disseminated locally in French, but to broader audiences in English (articles, conferences). Recognizing that translation is an interpretive act that can affect meaning, we will ensure that data are initially analyzed in the original language (coding and thematic analysis) to preserve linguistic and cultural nuance. Key quotations will be translated by bilingual team members, with translator annotations to contextualize culturally specific terms or concepts. When possible, collaborative review will be employed to enhance interpretive fidelity. This approach aims to maintain the authenticity of participants\u0026rsquo; voices while ensuring clarity and coherence in reporting for an international audience (33-35).\u003c/p\u003e\n\u003cp\u003eQuantitative and qualitative findings will be integrated during the interpretation phase to provide a comprehensive understanding of psychological distress in patients with chronic kidney disease and the perspectives of nephrology staff. Both data strands will be given equal weight in the analysis. Triangulation will be used to identify points of convergence, divergence, and complementarity between questionnaire results and interview or focus group themes. This approach ensures that statistical patterns are enriched by contextual and experiential insights, thereby informing the development of person-centered interventions grounded in both empirical trends and lived realities (20).\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis study will employ a sequential explanatory mixed methods design to explore psychological distress among patients with advanced CKD and to understand how mental health care is perceived and addressed by nephrology staff. By integrating quantitative data on distress prevalence, anxiety, depression, and quality of life with qualitative insights into the lived experience of patients and the perspectives of staff, this study will provide a comprehensive understanding of psychological needs within a single integrated nephrology care network (20).\u003c/p\u003e\n\u003cp\u003eThe study is innovative in its dual focus: it will assess the extent of psychological distress experienced by patients while also exploring systemic and professional-level factors that shape the capacity to address this distress in practice. High levels of psychological distress, including anxiety and depression, are well documented in individuals with CKD, with prevalence rates reaching 55% across treatment modalities (11, 13, 14). However, psychological needs often remain under-identified and insufficiently addressed in routine nephrology care. This project addresses that gap by incorporating both patient and provider perspectives, which is essential for the design of interventions that are both feasible and contextually appropriate (27).\u003c/p\u003e\n\u003cp\u003eThis is one of the first studies in Quebec – a majority French speaking population in Canada- to apply a mixed-methods approach to simultaneously capture both patient and provider experiences with psychosocial aspects of CKD care. It is also among the few that aim to identify modifiable characteristics of the healthcare environment—such as staff preparedness, time constraints, and referral pathways—that influence the integration of mental health care into nephrology services (Fletcher et al., 2022).\u003c/p\u003e\n\u003cp\u003eFindings from this research will contribute to the development of targeted, context-sensitive interventions aimed at improving the identification and management of psychological distress in patients with CKD. These interventions may include validated screening tools enhanced access to psychosocial professionals and strengthened interdisciplinary collaboration. In turn, such improvements could lead to better treatment adherence, increased patient satisfaction, and reduced reliance on acute care services (36, 37).\u003c/p\u003e\n\u003cp\u003eIn addition to its clinical impact, this study will advance theoretical understanding in health psychology by contributing to a contextual model of psychological distress in CKD and reinforcing person-centered care models (38). Insights gained may be transferable to other chronic disease populations and inform broader strategies for system-wide transformation in chronic care delivery (39).\u003c/p\u003e\n\u003cp\u003eThe use of both quantitative and qualitative methods will enable a more nuanced and holistic interpretation of patient and staff experiences. Triangulation of findings will ensure that numerical trends are complemented and enriched by in-depth narratives, enhancing the validity and utility of the results (20). This balanced integration of data types is critical to ensure that intervention development is grounded not only in prevalence estimates but also in the lived realities of those affected.\u003c/p\u003e\n\u003cp\u003eHowever, some limitations must be acknowledged. The use of quota-based convenience sampling in the patient population may introduce selection bias, as individuals who access care more frequently or are more engaged in their care may be overrepresented (40). Additionally, while focus groups offer rich data on shared experiences among staff, they may limit disclosure of sensitive or dissenting views (41). Finally, the translation of qualitative data from French to English for publication purposes presents the risk of subtle meaning loss; to mitigate this, bilingual researchers will be involved in translation and review (42, 43).\u003c/p\u003e\n\u003cp\u003eDespite these limitations, this study will generate practical knowledge that can inform the co-design of sustainable, person-centered interventions to better support the mental health and well-being of individuals living with CKD.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eCASQ\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eClinical and Administrative Staff Questionnaire\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eCHU\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eCentre Hospitalier Universitaire\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eCHUQ-UL\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eCHU de Qu\u0026eacute;bec\u0026ndash;Universit\u0026eacute; Laval\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eCKD\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eChronic Kidney Disease\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eDT\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eDistress Thermometer\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eeGFR\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eEstimated Glomerular Filtration Rate\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eESKD\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eEnd-Stage Kidney Disease\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eGIQ\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eGeneral Information Questionnaire\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eHADS\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eHospital Anxiety and Depression Scale\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eKDQL\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eKidney Disease Quality of Life Instrument\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eRRT\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eRenal Replacement Therapy\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eRTQ-V2\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eRenal Transplant Questionnaire, Version 2\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv class=\"DefinitionListEntry\"\u003e\u003cdiv class=\"Term\"\u003eUKMRC\u003c/div\u003e\u003cdiv class=\"Description\"\u003e\u003cp\u003eUnited Kingdom Medical Research Council\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eCLINICAL TRIAL NUMBER:\u0026nbsp;\u003c/strong\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eEthics approval and consent to participate\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Research Ethics Committee of CHU de Qu\u0026eacute;bec-Universit\u0026eacute; Laval has approved this study, registered under 2025-6835 and ensures follow-up. The study will be conducted in accordance with the Declaration of Helsinki. Participants will be given full study information and asked to provide written informed consent if they wish to participate. Sequential identification numbers will be attributed to each consenting participant to protect the confidentiality of their information. Only the principal study investigators will have access to the identification key which will be kept on a protected research server.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eConsent for publication\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eAvailability of data and materials\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eCompeting interests\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone of the research team members have competing interests in relation to this publication.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eFunding\u0026nbsp;\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work is supported by the Fonds de recherche du Qu\u0026eacute;bec-Sant\u0026eacute; (FRQS) through the research centre grant for the CHU de Qu\u0026eacute;bec-Universit\u0026eacute; Laval Research Center (reference: 30641), by clinical research grants from the Fondation du CHU de Qu\u0026eacute;bec-Universit\u0026eacute; Laval and from the F\u0026eacute;d\u0026eacute;ration des m\u0026eacute;decins r\u0026eacute;sidents du Qu\u0026eacute;bec (FMRQ), along with funding from Amgen Canada. CF is supported by the Amgen Research Chair in Nephrology, from the Fondation de l\u0026rsquo;Universit\u0026eacute; Laval and the Fonds de recherche du Qu\u0026eacute;bec \u0026ndash; Sant\u0026eacute; (FRQS, https://doi.org/10.69777/368036).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eAuthors\u0026rsquo; contributions\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMP, NZ, RL, and LC developed the research protocol, with methodological inputs from JCP and ACG. CF and MA revised the study protocol before submission for ethical approval. This study protocol article was written by MP and NZ. All the other authors revised the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eAcknowledgments\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to acknowledge the contribution of Aline Haaj, Sylvain Iceta, Sacha de Serres, Fabrice Mac-Way, Francesca Taylor and H\u0026eacute;l\u0026egrave;ne St-Jacques who have agreed to answer specific methodological questions concerning the research protocol and this manuscript. We would also like to thank the research team members (Lyna Kali, Alice Mailloux, Adrian Felipe Castilla), along with the clinical teams who have supported the beginning of recruitment.\u0026nbsp;\u003cbr\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eLv JC, Zhang LX. Prevalence and Disease Burden of Chronic Kidney Disease. Adv Exp Med Biol. 2019;1165:3\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, et al. Chronic kidney disease: global dimension and perspectives. Lancet. 2013;382(9888):260\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKitzler TM, Chun J. Understanding the current landscape of kidney disease in Canada to advance precision medicine\u0026ndash;guided personalized care. Can J Kidney Health Disease. 2023;10:20543581231154185.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBello AK, Tangri N. Prevalence and demographics of chronic kidney disease in Canadian primary care settings: data from CPCSSN 2010\u0026ndash;2015. JAMA Netw Open. 2019;2(10):e1917040.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAltintepe L, Levendoglu F, Okudan N, Guney I, Savas Cilli A, Ugurlu H, et al. Physical disability, psychological status, and health-related quality of life in older hemodialysis patients and age-matched controls. Hemodial Int. 2006;10(3):260\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBelasco A, Barbosa D, Bettencourt AR, Diccini S, Sesso R. Quality of life of family caregivers of elderly patients on hemodialysis and peritoneal dialysis. Am J Kidney Dis. 2006;48(6):955\u0026ndash;63.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEvans RW, Manninen DL, Garrison LP Jr., Hart LG, Blagg CR, Gutman RA, et al. The quality of life of patients with end-stage renal disease. N Engl J Med. 1985;312(9):553\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKurella Tamura M, Covinsky KE, Chertow GM, Yaffe K, Landefeld CS, McCulloch CE. Functional status of elderly adults before and after initiation of dialysis. N Engl J Med. 2009;361(16):1539\u0026ndash;47.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSolano JP, Gomes B, Higginson IJ. A comparison of symptom prevalence in far advanced cancer, AIDS, heart disease, chronic obstructive pulmonary disease and renal disease. J Pain Symptom Manage. 2006;31(1):58\u0026ndash;69.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eUlutas O, Farragher J, Chiu E, Cook WL, Jassal SV. Functional Disability in Older Adults Maintained on Peritoneal Dialysis Therapy. Perit Dial Int. 2016;36(1):71\u0026ndash;. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e\u0026thinsp;8.\u0026lt;\u003c/span\u003e\u003cspan address=\"http://\u0026thinsp;8.%3C\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eFletcher BR, Damery S, Aiyegbusi OL, Anderson N, Calvert M, Cockwell P, et al. Symptom burden and health-related quality of life in chronic kidney disease: A global systematic review and meta-analysis. PLoS Med. 2022;19(4):e1003954.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJones DJ, Harvey K, Harris JP, Butler LT, Vaux EC. Understanding the impact of haemodialysis on UK National Health Service patients' well-being: A qualitative investigation. J Clin Nurs. 2018;27(1\u0026ndash;2):193\u0026ndash;204.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNagy E, Tharwat S, Elsayed AM, Shabaka SAE, Nassar MK. Anxiety and depression in maintenance hemodialysis patients: prevalence and their effects on health-related quality of life. Int Urol Nephrol. 2023;55(11):2905\u0026ndash;14.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eYe W, Wang L, Wang Y, Wang C, Zeng J. Depression and anxiety symptoms among patients receiving maintenance hemodialysis: a single center cross-sectional study. BMC Nephrol. 2022;23(1):417.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCukor D, Fruchter Y, Ver Halen N, Naidoo S, Patel A, Saggi SJ. Psychological Adaptation to Serious Illness: A Qualitative Study of Advanced CKD Patients of Low Socioeconomic Status. Am J Hospice Palliat Med. 2020;37(1):71\u0026ndash;81.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCukor D, Cohen SD, Fruchter Y. Depression and anxiety in chronic kidney disease and ESRD: prevalence, mechanisms, and management strategies. Nephrol Rev. 2019;19(2):132\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNair D, Bonnet K, Wild MG, Umeukeje EM, Fissell RB, Faulkner ML, et al. Psychological Adaptation to Serious Illness: A Qualitative Study of Culturally Diverse Patients With Advanced Chronic Kidney Disease. J Pain Symptom Manage. 2021;61(1):32\u0026ndash;e412.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSchick-Makaroff K, Molzahn AE, Kalfoss M. Symptoms, Coping, and Quality of Life of People with Chronic Kidney Disease. Nephrol Nurs J. 2018;45(4):339\u0026ndash;55.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDavison SN, Jhangri GS. Existential and supportive care needs among patients with chronic kidney disease. J Pain Symptom Manage. 2010;40(6):838\u0026ndash;43.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCreswell JW, Plano Clark VL. Designing and Conducting Mixed Methods Research. 3 ed. Thousand Oaks, CA: Sage; 2018.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGo AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004;351(13):1296\u0026ndash;305.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePatton MQ. Qualitative Research \u0026amp; Evaluation Methods. 4 ed. Thousand Oaks, CA: Sage; 2015.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCarlsen B, Glenton C. What about N? A methodological study of sample-size reporting in focus group studies. BMC Med Res Methodol. 2011;11:26.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBrysbaert M. How Many Participants Do We Have to Include in Properly Powered Experiments? A Tutorial of Power Analysis with Reference Tables. J Cogn. 2019;2(1):16.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGuest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18(1):59\u0026ndash;82.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKrueger RA, Casey MA. Focus Groups: A Practical Guide for Applied Research. 5 ed. Thousand Oaks, CA: Sage; 2015.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTaylor F, Taylor C, Baharani J, Nicholas J, Combes G. Integrating emotional and psychological support into the end-stage renal disease pathway: a protocol for mixed methods research to identify patients' lower-level support needs and how these can most effectively be addressed. BMC Nephrol. 2016;17(1):111.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the kidney disease quality of life (KDQOL) instrument. Qual Life Res. 1994;3(5):329\u0026ndash;38.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eZigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361\u0026ndash;70.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRoth AJ, Kornblith AB, Batel-Copel L, Peabody E, Scher HI, Holland JC. Rapid screening for psychologic distress in men with prostate carcinoma: A pilot study. Cancer. 1998;82(10):1904\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMolzahn AE, Northcott HC, Landeen J. The development and testing of a quality of life questionnaire for renal transplant recipients. Nephrol Nurs J. 1997;24(4):53\u0026ndash;60.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBraun V, Clarke V. Using thematic analysis in psychology. Qualitative Res Psychol. 2006;3(2):77\u0026ndash;101.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSantos HP Jr., Black AM, Sandelowski M. Timing of translation in cross-language qualitative research. Qual Health Res. 2015;25(1):134\u0026ndash;44.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003evan Nes F, Abma T, Jonsson H, Deeg D. Language differences in qualitative research: is meaning lost in translation? Eur J Ageing. 2010;7(4):313\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSquires A. Methodological challenges in cross-language qualitative research: a research review. Int J Nurs Stud. 2009;46(2):277\u0026ndash;87.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eFuertes JN, Friedman OB, Moore MT, Rubinstein S. CKD Patients\u0026rsquo; Emotional Well\u0026ndash;Being: An Examination of Their Psychological Stressors and Support Factors. Kidney Dialysis. 2025;5(2):26.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRivera E, Clark\u0026ndash;Cutaia MN, Schrauben SJ, Townsend RR, Lash JP, Hannan M, et al. Treatment Adherence in CKD and Support From Health Care Providers: A Qualitative Study. Kidney Med. 2022;4(11):100545.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePicker Institute E. Person-Centred Care: From Ideas to Action. Picker Institute Europe; 2015.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMedical Research C. Developing and evaluating complex interventions: new guidance. UK Medical Research Council; 2021.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEtikan I, Musa SA, Alkassim RS. Comparison of convenience sampling and purposive sampling. Am J Theoretical Appl Stat. 2016;5(1):1\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBarbour RS. Doing Focus Groups. London: Sage; 2007.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSquires A. Methodological challenges in cross-language qualitative research: A research review. Int J Nurs Stud. 2009;46(2):277\u0026ndash;87.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003evan Nes F, Abma T, Jonsson H, Deeg D. Language differences in qualitative research: Is meaning lost in translation? Eur J Ageing. 2010;7(4):313\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-nephrology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bnep","sideBox":"Learn more about [BMC Nephrology](http://bmcnephrol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bnep/default.aspx","title":"BMC Nephrology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Chronic kidney disease, dialysis, kidney transplant, psychological distress, anxiety, depression, psychosocial support","lastPublishedDoi":"10.21203/rs.3.rs-7403255/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7403255/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e\u003cbr\u003e\n Chronic kidney disease (CKD) affects 8–16% of adults worldwide, including nearly 4 million Canadians. As the disease progresses, patients often experience a significant decline in quality of life (QoL), driven by disease-related symptoms and the burden of renal replacement therapies (RRT) such as dialysis and transplantation. In addition to physical symptoms, up to 55% of patients report psychological distress, including depression and anxiety. Despite this, mental health needs are frequently under-identified and insufficiently addressed in nephrology care. There is limited understanding of how patients experience and cope with this distress, how staff perceive their role in responding to it, and how healthcare environments support or hinder psychosocial care. This study seeks to address these gaps within a single integrated nephrology care network.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e\u003cbr\u003e\n \u0026nbsp;This explanatory sequential mixed-methods study will be conducted in two phases. In the first phase, quantitative data will be collected from 200 patients with CKD and 40–60 nephrology staff members using validated questionnaires assessing psychological distress, anxiety, depression, and QoL. Group comparisons will assess differences across RRT modalities, and association analyses will explore relationships between psychological outcomes and demographic or clinical factors. In the second phase, semi-structured interviews and focus groups with patients and staff will explore experiences of psychological distress and care delivery in greater depth. Thematic analysis will be used for qualitative data. Integration of findings through triangulation will provide a comprehensive understanding of psychosocial needs and inform intervention development.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e\u003cbr\u003e\n This study uses a mixed-methods design to investigate psychosocial needs in CKD care from both patient and provider perspectives. It aims to identify modifiable clinical and organizational factors—such as staff preparedness, referral practices, and systemic barriers—that shape the delivery of mental health support. Findings will inform the development of person-centered interventions and may guide broader models for integrating psychological care into chronic disease management.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatus of trial:\u003c/strong\u003e\u003cbr\u003e\n The study began in June 2024. 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