Effects of Telenursing-Based Family Centered Empowerment on the Fatigue and Sexual Satisfaction of Heart Failure Patients and Their Partners: A Randomized Controled Trial

Effects of Telenursing-Based Family Centered Empowerment on the Fatigue and Sexual Satisfaction of Heart Failure Patients and Their Partners: A Randomized Controled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effects of Telenursing-Based Family Centered Empowerment on the Fatigue and Sexual Satisfaction of Heart Failure Patients and Their Partners: A Randomized Controled Trial Mahnaz Rakhshan, Camellia Torabizadeh, Raha Azarban This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7623533/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 10 You are reading this latest preprint version Abstract Background: Heart failure (HF) is a chronic and progressive disease with extensive physical and psychological sequelae that affects not only patients but also their partners’ quality of life (QoL). This study aimed to determine the effects of telenursing-based family-centered empowerment (TFE) on the level of fatigue and sexual satisfaction of HF patients and their partners. Materials and Methods: This randomized clinical trial (RCT) was performed between February and June 2025 on a total of 100 participants (50 patients and 50 partners). The participants were randomly assigned to experimental and control groups. The experimental group received family-centered empowerment (FE) training via the WhatsApp platform for six weeks, followed by two-week telephone follow-up. However, the control group received only routine care. Data were collected via the Smets’ Multidimensional Fatigue Inventory (MFI) and Hudson’s Index of Sexual Satisfaction (ISS) before and eight weeks after the intervention and analyzed via appropriate statistical tests in SPSS version 25. Findings: The findings revealed that implementing the TFE intervention caused patients in the experimental group to experience a significant reduction in physical and mental fatigue and reduced activity components (P < 0.05). For the sexual satisfaction variable, only the two "quality of sexual life" and "sexual attitude" components significantly differed in the inter and intragroup analyses. Conclusion: The results of this study demonstrate that TFE is an effective approach for reducing fatigue in HF patients, improving the sexual satisfaction level of their partners, and can be used as part of care and rehabilitation programs for these patients and their partners. Trial registration: This study was prospectively registered in the Iranian Registry of Clinical Trials (IRCT) on January 28, 2025, under the registration number IRCT20241231064226N1. https://www.irct.ir/trial/64226 heart failure family-centered empowerment fatigue sexual satisfaction telenursing Figures Figure 1 Background Cardiovascular diseases (CVDs) are among the leading causes of mortality worldwide and have widespread physical, psychological, and social consequences [ 1 ]. According to the WHO, these diseases were responsible for approximately one-third of all deaths in 2021 [ 2 ]. Among the types of CVD, HF is considered a chronic and debilitating disease and one of the major health challenges in the U.S.A, with approximately 6.7 million people over the age of 20 currently suffering from it. This prevalence rate is expected to rise to 8.5 million by 2030 [ 3 ]. HF has a significant prevalence rate in Iran as well and is identified as one of the major public health challenges [ 4 ]. This disease imposes heavy costs on individuals and society as well as a significant physical and psychological burden on patients and families [ 5 ]. HF can cause various symptoms and complications such as fatigue, dyspnea, eoedema, and sexual dysfunction [ 6 ]. Fatigue is one of the most commonly reported and debilitating symptoms of these patients, affecting approximately 76–84% of them [ 7 , 8 ] and reducing their QoL and participation in self-care activities [ 9 ]. This type of fatigue affects not only HF patients but also their partners, affecting the physical, emotional, and social functioning of their families [ 10 ], and reducing the QoL of patients and their partners [ 11 ]. Sexual dysfunction has also been reported to be highly prevalent in these patients [ 12 ]and can lead to reduced mental health, marital dissatisfaction, and family tension [ 13 ]. Despite the importance of this issue, cultural and social taboos prevent many patients from speaking openly about their sexual problems, causing these problems to remain untreated [ 14 ]. Considering the major role of the family in caring for chronic patients, the FE model was developed in Iran by Alhani et al. (2003) the basis of a grounded theory (GT) qualitative approach with the aim of strengthening the role of the family in healthcare and improving the health outcomes of patients. Emphasizing the active participation of the family in the care process, this educational model promotes patients’ self-efficacy, self-esteem, and disease control. This model has four steps including the perception of threat, self-efficacy promotion, educational participation, and evaluation, which can be implemented in a structured manner in nursing education [ 15 ]. Previous studies have demonstrated that implementing this model not only improves patients’ health status, but also improves caregivers’ resilience and mental health and reduces their care burden [ 16 , 17 ]. Owing to the advent of digital transformation in the health system, the use of technologies such as telenursing presents a valuable opportunity to provide ongoing education and remote follow-up, and improve the quality of care [ 18 ]. This method has successfully reduced the mortality rate and readmissions, and improved QoL in the management of chronic diseases such as HF [ 19 ]. Despite numerous studies on the effects of telenursing on heart patients’ QoL [ 20 ], few studies have addressed the effects the effect of TFE on components such as fatigue and the sexual satisfaction of HF patients and their partners. These two components play a significant role in mental health, marital relationships, and QoL, and can be associated with significant negative consequences if they are neglected. With this in mind, we performed the present study to evaluate the effects of TFE on the fatigue and sexual satisfaction levels of HF patients and their partners. Methods Research Method The present study was an RCT with the registration code IRCT20241231064226N1, that was performed in Iran between February and June 2025. Participants and sampling The study population included heart failure (HF) patients and their spouses who attended the cardiology clinics of Imam Reza (AS) Polyclinic and Al-Zahra (SA) Heart Hospital, both affiliated with Shiraz University of Medical Sciences in Shiraz, Iran, and who met the inclusion criteria. Given that there has been little research on the topic under study, the sample size was determined via a pilot study and the opinions of a statistical consultant. Accordingly, 100 samples (50 couples) were selected using the convenience sampling method. To enssure the adequacy of the sample size to measure the effectiveness of the intervention on the fatigue and sexual satisfaction variables, a power analysis was performed via the MedCalc software package after the intervention to compare the means of two independent groups. On the basis of the patients’ fatigue scores, the power of the test was calculated as 98.7%. $$\:\varvec{n}=\frac{{({\varvec{Z}}_{1-\raisebox{1ex}{$\varvec{\alpha\:}$}\!\left/\:\!\raisebox{-1ex}{$2$}\right.}+{\varvec{Z}}_{1-\varvec{\beta\:}})}^{2}\:({\varvec{\sigma\:}}_{1}^{2}+{\varvec{\sigma\:}}_{2}^{2})\:}{{({\varvec{\mu\:}}_{1}-{\varvec{\mu\:}}_{2})}^{2}}$$ $$\:\varvec{n}=\frac{\left(\right(1.96\:+\:2.24)²\:\times\:\:(7.81²\:+\:14.13²\left)\right)}{(53.20\:-\:67.12)²}\varvec{˷}̴23.71$$ Participants were recruited and enrolled gradually. For every 10 eligible couples (a patient with heart failure and their spouse), the intervention process was initiated, allowing for staggered implementation across the study period. The inclusion criteria for patients were clinically stable HF (reduced ejection fraction or NYHA functional class of II–III for at least six months [ 21 ]), an age of 18 _ 65 years, marriage, ability to read and write in Persian, access to a smartphone and the internet, and willingness to participate in the study. The patients’ partners were also required to be within the age range of 18 _ 65 years, lack chronic debilitating diseases or psychiatric disorders, and have similar conditions. The exclusion criteria were the absence of more than two training sessions, hospitalization, withdrawal from the study, death of the patient, partial completion of questionnaires, or participation in similar training programs. Participants were randomly assigned to intervention or control groups using block randomization via software, implemented by the second research assistant. The first research assistant, unaware of the group allocation assignment method, was responsible for distributing and collecting the questionnaires. Moreover, the data were analyzed by a statistician unaware of the participants’ groupings to ensure that the conditions were blinded at different stages of the research. Data collection tools Data were collected in this study via the following three tools: 1. Demographic Survey : This survey was designed on the basis relevant literature and articles [ 22 , 23 ] and the opinions of the clinical team. The questionaire included questions asking about participants’ information such as age, gender, occupation, education level, body mass index (BMI), smoking history, and place of residence. 2. Hudson’s Index of Sexual Satisfaction (ISS) : A modified version of Hudson’s ISS developed by Larson was used. This instrument consists of 25 items in the four components of desire for sexual relations, sexual attitude, quality of sexual life, and sexual compatibility scored on a five-point Likert scale (from 1 (= never) to 5 (= always). The scores range from 25 to 125 and are categorized as follows: scores below 50 indicate sexual dissatisfaction, scores between 51 and 75 indicate low satisfaction, scores between 76 and 100 indicate moderate satisfaction and scores of 101 and above indicate high satisfaction [ 24 ]. The Persian version of this inventory was validated by Bahrami et al. (2016) and its reliability was confirmed with a Cronbach’s alpha of more than 0.70. Its validity was also evaluated and confirmed in terms of different psychometric properties including face, content, and construct via qualitative and quantitative methods [ 25 ]. 3. Multidimensional Fatigue Inventory (MFI-20) : This instrument was designed by Smets et al. (1995) in the Netherlands. It consists of 20 items and covers the following five components: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. It is scored on a five-point Likert scale from 1 (= strongly agree) to 5 (= strongly disagree); the total score ranges from 20 to 100, with higher scores indicating a higher level of fatigue. The reliability of the inventory was confirmed with a Cronbach’s alpha coefficient of more than 0.80 and convergent validity was confirmed with a visual analog scale [ 26 ]. The Persian version of this questionnaire was validated in a study by Safari et al. (2017), and its reliability and convergent validity were reported with a Cronbach’s alpha of 0.89 and a significance level of 0.01, respectively [ 27 ]. Implementation of the intervention After receiving the necessary permits from the ethics committee and registering the study in the clinical trial system, the researcher first coordinated with the officials of the medical centers in the selected medical centers and then reviewed the HF patients’ medical records to select those meeting the inclusion criteria. Sampling was carried out gradually and after the couples (HF patients and their partners) meeting the inclusion criteria, were identified, they were given informed consent forms (ICFs) as well as relevant questionnaires. After completing the questionnaires, the participants were divided into two experimental and control groups. This process continued in consecutive time intervals until the sample size (50 couples) was completed. In cases where a patient’s partner was not present at the time of the visit, the questionnaires were sent by phone or messenger and the patients were briefed on the phone to ensure the accuracy of their completion. The participation process is depicted in the CONSORT diagram (Fig. 1 ). The training intervention was subsequently implemented for the experimental group. The training intervention was designed for the experimental group on the basis of the FE model, and the educational content was extracted from scientific sources[ 28 , 29 ] and on the basis of the opinions of a panel of experts (a cardiologist, one with a PhD degree in nursing, a clinical educational supervisor, one with an M.S degree in midwifery). The training was presented through multimedia files (audio, video, PowerPoint) via the WhatsApp platform, which was preferred by 82% of the participants because of its ease of use and high interactivity. The training program comprised six structured online sessions held on a weekly basis, and then the continuous in-group interaction of the experimental group with the researcher on the educational platform and their individual communication by phone and SMS throughout the week enhanced their active participation as well as the effectiveness of the training process. The intervention was designed and implemented on the basis of the four steps of the FE model: Step 1 (Perception of threat) During two sessions, training was provided on the nature of the disease, its symptoms, complications, medication and regimen, and its impact on fatigue and sexual satisfaction. Step 2 (Improving self-efficacy) During three sessions, training was provided on deep breathing techniques in the correct way, the use of motivational spirometry, Kegel exercises, sexual hygiene, fatigue control, and relaxation. Step 3 (Improving self-esteem through educational participation) Participants reviewed the educational materials, exchanged information and practiced educational content in their family environment. Step 4 (Evaluation) At the beginning of each session, a process evaluation was conducted by asking questions from the previous session, and at the end of the intervention, a final evaluation was conducted in the eighth week on the basis of the questionnaires completed by participants in both the intervention and control groups. After the intervention, the researcher conducted educational follow-up and answered questions via phone calls every three days for two weeks (intervention group only). The participants were also allowed to call the researcher at any time. To observe the principles of research ethics, educational content was sent to the control group after the end of the study. All participants continued to receive standard medical care for heart failure throughout the trial, with no differences in concomitant treatments between the intervention and control groups. Data analysis Quantitative variables were reported as mean and standard deviation, and qualitative variables as frequency and percentage. Normality of data distribution was assessed using the Shapiro-Wilk and Kolmogorov-Smirnov tests. For normally distributed data, between-group comparisons were performed using independent t-tests, and within-group comparisons using paired t-tests. For non-normal data, appropriate non-parametric tests such as Mann–Whitney and Wilcoxon were used. Chi-square tests were applied for categorical variables. No missing data were observed during the trial; therefore, all analyses were performed on complete cases. No additional analyses, such as subgroup or sensitivity analyses, were performed.A significance level of P < 0.05 was considered for all analyses. Data were analyzed using SPSS version 25, and block randomization lists were generated using Random Allocation Software. Ethical consideration This study was performed after approval was obtained from the Ethics Committee of Shiraz University of Medical Sciences with an ethics code (IR.SUMS.NUMIMG.REC.1403.096). Before the start of the study, written informed consent was obtained from the participants, and the principles of data confidentiality, protection of the privacy of patients and their partners, and the right to withdraw from the study at any time without any negative consequences were observed in all stages of the study. The protocol of this study was developed according to the ethical guidelines of the Declaration of Helsinki adopted in 1975 and its subsequent amendments. This study was conducted and reported in accordance with the CONSORT guidelines for randomized controlled trials. Results The results of the study demonstrated that the mean (standard deviation) age of the patients was 48.64 ± 9.11 and that of their partners was 47.66 ± 9.65. Most of the patients were housewives and their partners were unemployed (17 each). Other baseline demographic data are presented in Table 1 . The results of the chi-square test, Fisher’s exact test, and independent t-test, revealed that the distributions of the demographic variables of the patients and their partners in the experimental and control groups were not significantly different (P > 0.05). Therefore, the two groups were homogeneous in terms of baseline characteristics (Table 1 ). The results of the paired t-test revealed a significant reduction in fatigue scores after the intervention in the patients in the experimental group (P = 0.017), but an insignificant reduction in the corresponding scores in the control group (P = 0.515). Moreover, no significant inter- intra group differences were observed in the fatigue scores of the patients’ partners (P > 0.05) (Table 2 ). With respect to the fatigue level of the patients and their partners, the FE intervention led to a significant reduction in physical and mental fatigue and reduced physical activity on the basis of paired t-tests, whereas the observed reductions in the general fatigue and reduced motivation components were not statistically significant. In the case of the patients’ partners, there was a significant intergroup difference only in the reduced motivation component after the intervention on the basis of the Mann‒Whitney test (P = 0.015), whereas none of the intragroup changes in the different components of fatigue reached a significant level (P > 0.05) (Table 3 ). The patients’ sexual satisfaction scores before and after the intervention did not differ significantly between the two groups (P > 0.05), and the intragroup changes were also insignificant. However, there was a significant difference between the groups of their partners after the intervention (P = 0.028) and within the control group (P = 0.002) (Table 4 ). The results of the test for the components of sexual satisfaction of patients and their partners indicated that none of the components underwent a significant intragroup change in the patients. However, the quality of sexual life after the intervention was significantly different between the two groups according to the Mann‒Whitney test (P = 0.001). In the case of their partners, the sexual attitude component improved significantly in the experimental group onaccording to the Wilcoxon test (P = 0.033). The quality of sexual life also showed a significant difference in the intergroup comparison after the intervention according to the independent t-test (P = 0.001), but the other components did not change significantly (Table 5 ). Finally, the findings of the test on the relationship between fatigue and the sexual satisfaction scores of the HF patients and their partners on the basis of their demographic characteristics revealed that, according to the Mann‒Whitney and Kruskal‒Wallis tests, the patients’ gender, education, and employment were significantly associated with the "reduced motivation" component (with a P-value of 0.014 for gender, 0.010 for education, and 0.033 for occupation), whereas the other variables showed no such relationship. Moreover, their partners’ gender, education, and smoking history were associated with the general fatigue (P = 0.043), reduced activity (P = 0.008), and mental fatigue (P = 0.009) components, respectively. None of the demographic characteristics had a statistically significant relationship with the sexual satisfaction of the patients or their partners (P > 0.05). Discussion The findings of this study demonstrated that the intervention led to a significant reduction in the patients’ levels of physical and mental fatigue and physical activity, whereas no significant change was observed in their general fatigue and motivation. These findings are consistent with those of Nagatomi et al. (2022), who reported that a comprehensive home-based cardiac rehabilitation (HBCR) program using ICT for HF patients with physical frailty improved exercise tolerance and improved lower extremity muscle strength [ 30 ]. Ziaeirad et al. (2017) also confirmed the effectiveness of energy conservation training techniques in reducing physical and mental fatigue [ 28 ], which is consistent with the mental fatigue component. The results of Kim et al. (2019) who reported a significant reduction in fatigue level through six-week telephone-delivered interventions indicate that telenursing is an effective tool for managing fatigue and improving participation in sedentary activities in these patients [ 21 ], which is consistent with the results of the reduced activity component. These studies highlight the effectiveness of training and rehabilitation interventions in reducing the fatigue level of HF patients. However, no statistically significant reduction in fatigue was recorded in the partners’ scores, although an insignificant decreasing trend was observed in some components. This finding could be attributed to factors such as differences in the partners’ participation in training sessions, their supportive role, or the lack of direct focus of the intervention on their psychological needs. Although previous studies have reported similar results in terms of patients’ fatigue levels, the present study provides a different and more comprehensive framework in the family environment by employing a dyadic approach, i.e. involving both patients and partners, and a limited sample size. These features make it distinctive in terms of intervention structure and the scope of assessment. With respect to sexual satisfaction, the intervention had a significant effect on the patients only in terms of the quality of sexual life component in the intergroup comparison, whereas a significant difference was observed in their partners in terms of components such as sexual attitude and quality of sexual life. However, there were no significant differences in other components including the desire to have sexual relationships and sexual compatibility. These findings are consistent with those of Rabeipoor et al. (2024) [ 31 ], who reported a significant improvement in the scores of quality of sexual life and marital satisfaction of the wives of men suffering from myocardial infarction after in-person couple-centered counseling on the basis of the CHARMS model. Differences in the presentation method (online vs. in-person), assessment method (both partners vs. one partner), and cultural context could explain the differences in the results of the present study and those of Rabeipoor. FE intervention was effective in improving sexual attitudes and QoL, especially among patients’ partners, but did not significantly affect behavioral aspects such as sexual desire and compatibility. One possible reason for this is the use of cardiac medications such as beta-blockers, which have also been shown in previous studies to be associated with reduced sexual desire [ 32 ]. These results indicate the need to design more comprehensive interventions focusing on psychosexual dimensions and drug effects in couples with chronic diseases. Statistical analyses revealed that some demographic characteristics such as sex, education, smoking history, and employment level were significantly associated with certain components of fatigue. This finding was also confirmed by Ziaeirad et al. (2017), who reported that the severity of fatigue was associated with the level of education and the presence of chronic diseases [ 22 ], whereas none of these characteristics had a statistically significant relationship with sexual satisfaction. This finding indicates that sexual satisfaction is more affected by psychological factors and interpersonal relationships than by demographic factors, which was confirmed by Baert et al. (2019) [ 33 ]. Research limitations and suggestions This study has limitations that should be taken into consideration when interpreting the results. The focus on patients and their partners in a specific region may limit the generalizability of the findings. The use of self-report questionnaires may also have affected the accuracy of the responses. To increase the validity of the results, future studies should use larger samples, a combination of quantitative (questionnaire) and qualitative (interview) methods, and multistage measurements. Furthermore, the implementation of the intervention over a short period of time and the lack of long-term evaluation have limited the sustainability of the effects. External factors such as differences in access to technology, clinical conditions, and the level of partner participation may also have influenced the results. The study lacked standardized tools to assess sexual barriers and did not control for medications affecting sexual function, which may have influenced the interpretation of sexual satisfaction outcomes. Future research should use larger, more diverse samples, combine quantitative and qualitative methods, and include long-term follow-up. Controlling for confounding factors and using validated instruments in sensitive domains like sexual health is also recommended. Conclusion The results of this study demonstrated that TFE intervention can significantly improve physical and mental fatigue in HF patients reduced activity. Despite limited changes in the partners’ sexual satisfaction levels, relative improvements were observed in components such as sexual attitudes and quality of sexual life. These findings confirm the effective role of a family-centered approach in the care of HF patients and highlight the effective use of modern technologies in reducing fatigue and improving some aspects of sexual satisfaction. Considering the advantages of this method, including its cost-effectiveness, elimination of spatial and temporal constraints, and easier acceptance, similar interventions should be implemented with a larger sample size, for a longer follow-up period, and in different groups of chronic patients to ensure a more accurate evaluation of the effectiveness and sustainability of the results. Declarations Ethics approval and consent to participate: This study was performed after approval was obtained from the Ethics Committee of Shiraz University of Medical Sciences with an ethics code (IR.SUMS.NUMIMG.REC.1403.096). Before the start of the study, written informed consent was obtained from the participants, and the principles of data confidentiality, protection of the privacy of patients and their partners, and the right to withdraw from the study at any time without any negative consequences were observed in all stages of the study. The protocol of this study was developed according to the ethical guidelines of the Declaration of Helsinki adopted in 1975 and its subsequent amendments. Consent for publication : Not applicable Availability of data and materials: The datasets generated and/or analysed during the current study will be made publicly available upon publication of this article. Competing interests: The authors declare that they have no competing interests. Funding: This research was financially supported by Shiraz University of Medical Sciences. Authors' contributions: MR conceptualized and supervised the study, led the project, analyzed and interpreted the data, and served as the guarantor and corresponding author. CT contributed to the study design and statistical analysis, developed the intellectual content, and critically reviewed and edited the manuscript. RA conducted the literature review and clinical implementation, collected the data, drafted the manuscript, and assisted in preparing the final version for submission. All authors read and approved the final manuscript. Acknowledgement The authors would like to appreciate the Vice Chancellor for Research and Technology of Shiraz University of Medical Sciences for financial support of this research project. They also sincerely thank the staff and management of the School of Nursing and Midwifery and the patients who participated in this study. References Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, et al. Global burden of cardiovascular diseases and risk factors, 1990–2019: update from the GBD 2019 study. Journal of the American college of cardiology. 2020;76(25):2982-3021. Di Cesare M, Perel P, Taylor S, Kabudula C, Bixby H, Gaziano TA, et al. The Heart of the World. Glob Heart. 2024;19(1):11. 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Investigating the impact of couple counseling based on the CHARMS model on sexual quality of life and marital satisfaction of wives of men suffering from myocardial infarction: a study protocol. Reproductive Health. 2024;21(1):55. Corona G, Vena W, Pizzocaro A, Salvio G, Sparano C, Sforza A, et al. Anti-hypertensive medications and erectile dysfunction: focus on β-blockers. Endocrine. 2025;87(1):11-26. Baert A, Pardaens S, De Smedt D, Puddu PE, Ciancarelli MC, Dawodu A, et al. Sexual activity in heart failure patients: information needs and association with health-related quality of life. International journal of environmental research and public health. 2019;16(9):1570. Tables Tables 1 to 5 are available in the Supplementary Files section Additional Declarations No competing interests reported. Supplementary Files Tables.docx Cite Share Download PDF Status: Under Review Version 1 posted Reviews received at journal 12 Nov, 2025 Reviewers agreed at journal 09 Nov, 2025 Reviews received at journal 04 Nov, 2025 Reviewers agreed at journal 28 Oct, 2025 Reviewers agreed at journal 27 Oct, 2025 Reviewers invited by journal 27 Oct, 2025 Editor assigned by journal 20 Oct, 2025 Editor invited by journal 29 Sep, 2025 Submission checks completed at journal 27 Sep, 2025 First submitted to journal 27 Sep, 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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1","display":"","copyAsset":false,"role":"figure","size":93473,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart of participant recruitment, randomization, and retention based on CONSORT guidelines.\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7623533/v1/bd3805a8e0d60f791dfa1e06.jpg"},{"id":95653866,"identity":"026146fa-b210-4e29-a58f-4a82ff1c793c","added_by":"auto","created_at":"2025-11-11 16:03:01","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":768910,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7623533/v1/557363c8-57f3-476b-9026-c2e4445a3850.pdf"},{"id":95321984,"identity":"b2a05a07-1508-416b-83e2-3c3faad7a7ec","added_by":"auto","created_at":"2025-11-06 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According to the WHO, these diseases were responsible for approximately one-third of all deaths in 2021 [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAmong the types of CVD, HF is considered a chronic and debilitating disease and one of the major health challenges in the U.S.A, with approximately 6.7\u0026nbsp;million people over the age of 20 currently suffering from it. This prevalence rate is expected to rise to 8.5\u0026nbsp;million by 2030 [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. HF has a significant prevalence rate in Iran as well and is identified as one of the major public health challenges [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. This disease imposes heavy costs on individuals and society as well as a significant physical and psychological burden on patients and families [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eHF can cause various symptoms and complications such as fatigue, dyspnea, eoedema, and sexual dysfunction [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Fatigue is one of the most commonly reported and debilitating symptoms of these patients, affecting approximately 76\u0026ndash;84% of them [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] and reducing their QoL and participation in self-care activities [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. This type of fatigue affects not only HF patients but also their partners, affecting the physical, emotional, and social functioning of their families [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], and reducing the QoL of patients and their partners [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eSexual dysfunction has also been reported to be highly prevalent in these patients [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]and can lead to reduced mental health, marital dissatisfaction, and family tension [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Despite the importance of this issue, cultural and social taboos prevent many patients from speaking openly about their sexual problems, causing these problems to remain untreated [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eConsidering the major role of the family in caring for chronic patients, the FE model was developed in Iran by Alhani et al. (2003) the basis of a grounded theory (GT) qualitative approach with the aim of strengthening the role of the family in healthcare and improving the health outcomes of patients. Emphasizing the active participation of the family in the care process, this educational model promotes patients\u0026rsquo; self-efficacy, self-esteem, and disease control. This model has four steps including the perception of threat, self-efficacy promotion, educational participation, and evaluation, which can be implemented in a structured manner in nursing education [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Previous studies have demonstrated that implementing this model not only improves patients\u0026rsquo; health status, but also improves caregivers\u0026rsquo; resilience and mental health and reduces their care burden [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eOwing to the advent of digital transformation in the health system, the use of technologies such as telenursing presents a valuable opportunity to provide ongoing education and remote follow-up, and improve the quality of care [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. This method has successfully reduced the mortality rate and readmissions, and improved QoL in the management of chronic diseases such as HF [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eDespite numerous studies on the effects of telenursing on heart patients\u0026rsquo; QoL [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], few studies have addressed the effects the effect of TFE on components such as fatigue and the sexual satisfaction of HF patients and their partners. These two components play a significant role in mental health, marital relationships, and QoL, and can be associated with significant negative consequences if they are neglected. With this in mind, we performed the present study to evaluate the effects of TFE on the fatigue and sexual satisfaction levels of HF patients and their partners.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003eResearch Method\u003c/h2\u003e\n \u003cp\u003eThe present study was an RCT with the registration code IRCT20241231064226N1, that was performed in Iran between February and June 2025.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eParticipants and sampling\u003c/h3\u003e\n\u003cp\u003eThe study population included heart failure (HF) patients and their spouses who attended the cardiology clinics of Imam Reza (AS) Polyclinic and Al-Zahra (SA) Heart Hospital, both affiliated with Shiraz University of Medical Sciences in Shiraz, Iran, and who met the inclusion criteria.\u003c/p\u003e\n\u003cp\u003eGiven that there has been little research on the topic under study, the sample size was determined via a pilot study and the opinions of a statistical consultant. Accordingly, 100 samples (50 couples) were selected using the convenience sampling method. To enssure the adequacy of the sample size to measure the effectiveness of the intervention on the fatigue and sexual satisfaction variables, a power analysis was performed via the MedCalc software package after the intervention to compare the means of two independent groups. On the basis of the patients\u0026rsquo; fatigue scores, the power of the test was calculated as 98.7%.\u003c/p\u003e\n\u003cdiv id=\"Equa\" class=\"Equation\"\u003e\n \u003cdiv class=\"mathdisplay\" id=\"FileID_Equa\" name=\"EquationSource\"\u003e$$\\:\\varvec{n}=\\frac{{({\\varvec{Z}}_{1-\\raisebox{1ex}{$\\varvec{\\alpha\\:}$}\\!\\left/\\:\\!\\raisebox{-1ex}{$2$}\\right.}+{\\varvec{Z}}_{1-\\varvec{\\beta\\:}})}^{2}\\:({\\varvec{\\sigma\\:}}_{1}^{2}+{\\varvec{\\sigma\\:}}_{2}^{2})\\:}{{({\\varvec{\\mu\\:}}_{1}-{\\varvec{\\mu\\:}}_{2})}^{2}}$$\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Equb\" class=\"Equation\"\u003e\n \u003cdiv class=\"mathdisplay\" id=\"FileID_Equb\" name=\"EquationSource\"\u003e$$\\:\\varvec{n}=\\frac{\\left(\\right(1.96\\:+\\:2.24)\u0026sup2;\\:\\times\\:\\:(7.81\u0026sup2;\\:+\\:14.13\u0026sup2;\\left)\\right)}{(53.20\\:-\\:67.12)\u0026sup2;}\\varvec{˷}̴23.71$$\u003c/div\u003e\n\u003c/div\u003e\n\u003cp\u003eParticipants were recruited and enrolled gradually. For every 10 eligible couples (a patient with heart failure and their spouse), the intervention process was initiated, allowing for staggered implementation across the study period.\u003c/p\u003e\n\u003cp\u003eThe inclusion criteria for patients were clinically stable HF (reduced ejection fraction or NYHA functional class of II\u0026ndash;III for at least six months [\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e]), an age of 18\u003csup\u003e_\u003c/sup\u003e 65 years, marriage, ability to read and write in Persian, access to a smartphone and the internet, and willingness to participate in the study. The patients\u0026rsquo; partners were also required to be within the age range of 18\u003csup\u003e_\u003c/sup\u003e65 years, lack chronic debilitating diseases or psychiatric disorders, and have similar conditions. The exclusion criteria were the absence of more than two training sessions, hospitalization, withdrawal from the study, death of the patient, partial completion of questionnaires, or participation in similar training programs. Participants were randomly assigned to intervention or control groups using block randomization via software, implemented by the second research assistant. The first research assistant, unaware of the group allocation assignment method, was responsible for distributing and collecting the questionnaires. Moreover, the data were analyzed by a statistician unaware of the participants\u0026rsquo; groupings to ensure that the conditions were blinded at different stages of the research.\u003c/p\u003e\n\u003ch3\u003eData collection tools\u003c/h3\u003e\n\u003cp\u003eData were collected in this study via the following three tools:\u003c/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1. Demographic Survey\u003c/strong\u003e: This survey was designed on the basis relevant literature and articles [\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e] and the opinions of the clinical team. The questionaire included questions asking about participants\u0026rsquo; information such as age, gender, occupation, education level, body mass index (BMI), smoking history, and place of residence.\u003c/p\u003e\u003cspan\u003e\n \u003cp\u003e2. \u003cstrong\u003eHudson\u0026rsquo;s Index of Sexual Satisfaction (ISS)\u003c/strong\u003e: A modified version of Hudson\u0026rsquo;s ISS developed by Larson was used. This instrument consists of 25 items in the four components of desire for sexual relations, sexual attitude, quality of sexual life, and sexual compatibility scored on a five-point Likert scale (from 1 (=\u0026thinsp;never) to 5 (=\u0026thinsp;always). The scores range from 25 to 125 and are categorized as follows: scores below 50 indicate sexual dissatisfaction, scores between 51 and 75 indicate low satisfaction, scores between 76 and 100 indicate moderate satisfaction and scores of 101 and above indicate high satisfaction [\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e]. The Persian version of this inventory was validated by Bahrami et al. (2016) and its reliability was confirmed with a Cronbach\u0026rsquo;s alpha of more than 0.70. Its validity was also evaluated and confirmed in terms of different psychometric properties including face, content, and construct via qualitative and quantitative methods [\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e].\u003c/p\u003e\n\u003c/span\u003e\u003cspan\u003e\n \u003cp\u003e3. \u003cstrong\u003eMultidimensional Fatigue Inventory (MFI-20)\u003c/strong\u003e: This instrument was designed by Smets et al. (1995) in the Netherlands. It consists of 20 items and covers the following five components: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. It is scored on a five-point Likert scale from 1 (=\u0026thinsp;strongly agree) to 5 (=\u0026thinsp;strongly disagree); the total score ranges from 20 to 100, with higher scores indicating a higher level of fatigue. The reliability of the inventory was confirmed with a Cronbach\u0026rsquo;s alpha coefficient of more than 0.80 and convergent validity was confirmed with a visual analog scale [\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e]. The Persian version of this questionnaire was validated in a study by Safari et al. (2017), and its reliability and convergent validity were reported with a Cronbach\u0026rsquo;s alpha of 0.89 and a significance level of 0.01, respectively [\u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e\n\u003c/span\u003e\n\u003cp\u003e\u003c/p\u003e\n\u003ch3\u003eImplementation of the intervention\u003c/h3\u003e\n\u003cp\u003eAfter receiving the necessary permits from the ethics committee and registering the study in the clinical trial system, the researcher first coordinated with the officials of the medical centers in the selected medical centers and then reviewed the HF patients\u0026rsquo; medical records to select those meeting the inclusion criteria. Sampling was carried out gradually and after the couples (HF patients and their partners) meeting the inclusion criteria, were identified, they were given informed consent forms (ICFs) as well as relevant questionnaires. After completing the questionnaires, the participants were divided into two experimental and control groups. This process continued in consecutive time intervals until the sample size (50 couples) was completed. In cases where a patient\u0026rsquo;s partner was not present at the time of the visit, the questionnaires were sent by phone or messenger and the patients were briefed on the phone to ensure the accuracy of their completion. The participation process is depicted in the CONSORT diagram (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). The training intervention was subsequently implemented for the experimental group.\u003c/p\u003e\n\u003cp\u003eThe training intervention was designed for the experimental group on the basis of the FE model, and the educational content was extracted from scientific sources[\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e] and on the basis of the opinions of a panel of experts (a cardiologist, one with a PhD degree in nursing, a clinical educational supervisor, one with an M.S degree in midwifery). The training was presented through multimedia files (audio, video, PowerPoint) via the WhatsApp platform, which was preferred by 82% of the participants because of its ease of use and high interactivity. The training program comprised six structured online sessions held on a weekly basis, and then the continuous in-group interaction of the experimental group with the researcher on the educational platform and their individual communication by phone and SMS throughout the week enhanced their active participation as well as the effectiveness of the training process.\u003c/p\u003e\n\u003cp\u003eThe intervention was designed and implemented on the basis of the four steps of the FE model:\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStep 1 (Perception of threat)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDuring two sessions, training was provided on the nature of the disease, its symptoms, complications, medication and regimen, and its impact on fatigue and sexual satisfaction.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStep 2 (Improving self-efficacy)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDuring three sessions, training was provided on deep breathing techniques in the correct way, the use of motivational spirometry, Kegel exercises, sexual hygiene, fatigue control, and relaxation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStep 3 (Improving self-esteem through educational participation)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants reviewed the educational materials, exchanged information and practiced educational content in their family environment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStep 4 (Evaluation)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAt the beginning of each session, a process evaluation was conducted by asking questions from the previous session, and at the end of the intervention, a final evaluation was conducted in the eighth week on the basis of the questionnaires completed by participants in both the intervention and control groups.\u003c/p\u003e\n\u003cp\u003eAfter the intervention, the researcher conducted educational follow-up and answered questions via phone calls every three days for two weeks (intervention group only). The participants were also allowed to call the researcher at any time. To observe the principles of research ethics, educational content was sent to the control group after the end of the study.\u003c/p\u003e\n\u003cp\u003eAll participants continued to receive standard medical care for heart failure throughout the trial, with no differences in concomitant treatments between the intervention and control groups.\u003c/p\u003e\n\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\n \u003ch2\u003eData analysis\u003c/h2\u003e\n \u003cp\u003eQuantitative variables were reported as mean and standard deviation, and qualitative variables as frequency and percentage. Normality of data distribution was assessed using the Shapiro-Wilk and Kolmogorov-Smirnov tests. For normally distributed data, between-group comparisons were performed using independent t-tests, and within-group comparisons using paired t-tests. For non-normal data, appropriate non-parametric tests such as Mann\u0026ndash;Whitney and Wilcoxon were used. Chi-square tests were applied for categorical variables. No missing data were observed during the trial; therefore, all analyses were performed on complete cases. No additional analyses, such as subgroup or sensitivity analyses, were performed.A significance level of P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered for all analyses. Data were analyzed using SPSS version 25, and block randomization lists were generated using Random Allocation Software.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003eEthical consideration\u003c/h2\u003e\n \u003cp\u003eThis study was performed after approval was obtained from the Ethics Committee of Shiraz University of Medical Sciences with an ethics code (IR.SUMS.NUMIMG.REC.1403.096). Before the start of the study, written informed consent was obtained from the participants, and the principles of data confidentiality, protection of the privacy of patients and their partners, and the right to withdraw from the study at any time without any negative consequences were observed in all stages of the study. The protocol of this study was developed according to the ethical guidelines of the Declaration of Helsinki adopted in 1975 and its subsequent amendments.\u003c/p\u003e\n \u003cp\u003eThis study was conducted and reported in accordance with the CONSORT guidelines for randomized controlled trials.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThe results of the study demonstrated that the mean (standard deviation) age of the patients was 48.64\u0026thinsp;\u0026plusmn;\u0026thinsp;9.11 and that of their partners was 47.66\u0026thinsp;\u0026plusmn;\u0026thinsp;9.65. Most of the patients were housewives and their partners were unemployed (17 each). Other baseline demographic data are presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The results of the chi-square test, Fisher\u0026rsquo;s exact test, and independent t-test, revealed that the distributions of the demographic variables of the patients and their partners in the experimental and control groups were not significantly different (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Therefore, the two groups were homogeneous in terms of baseline characteristics (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe results of the paired t-test revealed a significant reduction in fatigue scores after the intervention in the patients in the experimental group (P\u0026thinsp;=\u0026thinsp;0.017), but an insignificant reduction in the corresponding scores in the control group (P\u0026thinsp;=\u0026thinsp;0.515). Moreover, no significant inter- intra group differences were observed in the fatigue scores of the patients\u0026rsquo; partners (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05) (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eWith respect to the fatigue level of the patients and their partners, the FE intervention led to a significant reduction in physical and mental fatigue and reduced physical activity on the basis of paired t-tests, whereas the observed reductions in the general fatigue and reduced motivation components were not statistically significant. In the case of the patients\u0026rsquo; partners, there was a significant intergroup difference only in the reduced motivation component after the intervention on the basis of the Mann‒Whitney test (P\u0026thinsp;=\u0026thinsp;0.015), whereas none of the intragroup changes in the different components of fatigue reached a significant level (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe patients\u0026rsquo; sexual satisfaction scores before and after the intervention did not differ significantly between the two groups (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05), and the intragroup changes were also insignificant. However, there was a significant difference between the groups of their partners after the intervention (P\u0026thinsp;=\u0026thinsp;0.028) and within the control group (P\u0026thinsp;=\u0026thinsp;0.002) (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eThe results of the test for the components of sexual satisfaction of patients and their partners indicated that none of the components underwent a significant intragroup change in the patients. However, the quality of sexual life after the intervention was significantly different between the two groups according to the Mann‒Whitney test (P\u0026thinsp;=\u0026thinsp;0.001). In the case of their partners, the sexual attitude component improved significantly in the experimental group onaccording to the Wilcoxon test (P\u0026thinsp;=\u0026thinsp;0.033). The quality of sexual life also showed a significant difference in the intergroup comparison after the intervention according to the independent t-test (P\u0026thinsp;=\u0026thinsp;0.001), but the other components did not change significantly (Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eFinally, the findings of the test on the relationship between fatigue and the sexual satisfaction scores of the HF patients and their partners on the basis of their demographic characteristics revealed that, according to the Mann‒Whitney and Kruskal‒Wallis tests, the patients\u0026rsquo; gender, education, and employment were significantly associated with the \"reduced motivation\" component (with a P-value of 0.014 for gender, 0.010 for education, and 0.033 for occupation), whereas the other variables showed no such relationship. Moreover, their partners\u0026rsquo; gender, education, and smoking history were associated with the general fatigue (P\u0026thinsp;=\u0026thinsp;0.043), reduced activity (P\u0026thinsp;=\u0026thinsp;0.008), and mental fatigue (P\u0026thinsp;=\u0026thinsp;0.009) components, respectively. None of the demographic characteristics had a statistically significant relationship with the sexual satisfaction of the patients or their partners (P\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe findings of this study demonstrated that the intervention led to a significant reduction in the patients\u0026rsquo; levels of physical and mental fatigue and physical activity, whereas no significant change was observed in their general fatigue and motivation. These findings are consistent with those of Nagatomi et al. (2022), who reported that a comprehensive home-based cardiac rehabilitation (HBCR) program using ICT for HF patients with physical frailty improved exercise tolerance and improved lower extremity muscle strength [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Ziaeirad et al. (2017) also confirmed the effectiveness of energy conservation training techniques in reducing physical and mental fatigue [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e], which is consistent with the mental fatigue component. The results of Kim et al. (2019) who reported a significant reduction in fatigue level through six-week telephone-delivered interventions indicate that telenursing is an effective tool for managing fatigue and improving participation in sedentary activities in these patients [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e], which is consistent with the results of the reduced activity component. These studies highlight the effectiveness of training and rehabilitation interventions in reducing the fatigue level of HF patients.\u003c/p\u003e\u003cp\u003eHowever, no statistically significant reduction in fatigue was recorded in the partners\u0026rsquo; scores, although an insignificant decreasing trend was observed in some components. This finding could be attributed to factors such as differences in the partners\u0026rsquo; participation in training sessions, their supportive role, or the lack of direct focus of the intervention on their psychological needs.\u003c/p\u003e\u003cp\u003eAlthough previous studies have reported similar results in terms of patients\u0026rsquo; fatigue levels, the present study provides a different and more comprehensive framework in the family environment by employing a dyadic approach, i.e. involving both patients and partners, and a limited sample size. These features make it distinctive in terms of intervention structure and the scope of assessment.\u003c/p\u003e\u003cp\u003eWith respect to sexual satisfaction, the intervention had a significant effect on the patients only in terms of the quality of sexual life component in the intergroup comparison, whereas a significant difference was observed in their partners in terms of components such as sexual attitude and quality of sexual life. However, there were no significant differences in other components including the desire to have sexual relationships and sexual compatibility. These findings are consistent with those of Rabeipoor et al. (2024) [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e], who reported a significant improvement in the scores of quality of sexual life and marital satisfaction of the wives of men suffering from myocardial infarction after in-person couple-centered counseling on the basis of the CHARMS model. Differences in the presentation method (online vs. in-person), assessment method (both partners vs. one partner), and cultural context could explain the differences in the results of the present study and those of Rabeipoor.\u003c/p\u003e\u003cp\u003eFE intervention was effective in improving sexual attitudes and QoL, especially among patients\u0026rsquo; partners, but did not significantly affect behavioral aspects such as sexual desire and compatibility. One possible reason for this is the use of cardiac medications such as beta-blockers, which have also been shown in previous studies to be associated with reduced sexual desire [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. These results indicate the need to design more comprehensive interventions focusing on psychosexual dimensions and drug effects in couples with chronic diseases.\u003c/p\u003e\u003cp\u003eStatistical analyses revealed that some demographic characteristics such as sex, education, smoking history, and employment level were significantly associated with certain components of fatigue. This finding was also confirmed by Ziaeirad et al. (2017), who reported that the severity of fatigue was associated with the level of education and the presence of chronic diseases [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e], whereas none of these characteristics had a statistically significant relationship with sexual satisfaction. This finding indicates that sexual satisfaction is more affected by psychological factors and interpersonal relationships than by demographic factors, which was confirmed by Baert et al. (2019) [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e].\u003c/p\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eResearch limitations and suggestions\u003c/h2\u003e\u003cp\u003eThis study has limitations that should be taken into consideration when interpreting the results. The focus on patients and their partners in a specific region may limit the generalizability of the findings. The use of self-report questionnaires may also have affected the accuracy of the responses. To increase the validity of the results, future studies should use larger samples, a combination of quantitative (questionnaire) and qualitative (interview) methods, and multistage measurements. Furthermore, the implementation of the intervention over a short period of time and the lack of long-term evaluation have limited the sustainability of the effects. External factors such as differences in access to technology, clinical conditions, and the level of partner participation may also have influenced the results. The study lacked standardized tools to assess sexual barriers and did not control for medications affecting sexual function, which may have influenced the interpretation of sexual satisfaction outcomes. Future research should use larger, more diverse samples, combine quantitative and qualitative methods, and include long-term follow-up. Controlling for confounding factors and using validated instruments in sensitive domains like sexual health is also recommended.\u003c/p\u003e\u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe results of this study demonstrated that TFE intervention can significantly improve physical and mental fatigue in HF patients reduced activity. Despite limited changes in the partners\u0026rsquo; sexual satisfaction levels, relative improvements were observed in components such as sexual attitudes and quality of sexual life. These findings confirm the effective role of a family-centered approach in the care of HF patients and highlight the effective use of modern technologies in reducing fatigue and improving some aspects of sexual satisfaction. Considering the advantages of this method, including its cost-effectiveness, elimination of spatial and temporal constraints, and easier acceptance, similar interventions should be implemented with a larger sample size, for a longer follow-up period, and in different groups of chronic patients to ensure a more accurate evaluation of the effectiveness and sustainability of the results.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u0026nbsp;\u003c/strong\u003eThis study was performed after approval was obtained from the Ethics Committee of Shiraz University of Medical Sciences with an ethics code (IR.SUMS.NUMIMG.REC.1403.096). Before the start of the study, written informed consent was obtained from the participants, and the principles of data confidentiality, protection of the privacy of patients and their partners, and the right to withdraw from the study at any time without any negative consequences were observed in all stages of the study. The protocol of this study was developed according to the ethical guidelines of the Declaration of Helsinki adopted in 1975 and its subsequent amendments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e: Not applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u0026nbsp;\u003c/strong\u003eThe datasets generated and/or analysed during the current study will be made publicly available upon publication of this article.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u0026nbsp;\u003c/strong\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eThis research was financially supported by Shiraz University of Medical Sciences.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions:\u0026nbsp;\u003c/strong\u003eMR conceptualized and supervised the study, led the project, analyzed and interpreted the data, and served as the guarantor and corresponding author. CT contributed to the study design and statistical analysis, developed the intellectual content, and critically reviewed and edited the manuscript. RA conducted the literature review and clinical implementation, collected the data, drafted the manuscript, and assisted in preparing the final version for submission. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to appreciate the Vice Chancellor for Research and Technology of Shiraz University of Medical Sciences for financial support of this research project. They also sincerely thank the staff and management of the School of Nursing and Midwifery and the patients who participated in this study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eRoth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, et al. Global burden of cardiovascular diseases and risk factors, 1990\u0026ndash;2019: update from the GBD 2019 study. Journal of the American college of cardiology. 2020;76(25):2982-3021.\u003c/li\u003e\n\u003cli\u003eDi Cesare M, Perel P, Taylor S, Kabudula C, Bixby H, Gaziano TA, et al. The Heart of the World. Glob Heart. 2024;19(1):11.\u003c/li\u003e\n\u003cli\u003eBozkurt B, Ahmad T, Alexander K, Baker W, Bosak K, Breathett K, et al. TEMPORARY REMOVAL: Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. Journal of Cardiac Failure. 2023:S1071-9164 (23) 00264.\u003c/li\u003e\n\u003cli\u003eAllahyari J, Jahantigh F, Saadatifar B, Jafari J, Sargolzaei MS. Readmission determinants in Iranian people with heart failure: A literature review. 2022.\u003c/li\u003e\n\u003cli\u003eKazi DS, Elkind MS, Deutsch A, Dowd WN, Heidenreich P, Khavjou O, et al. Forecasting the economic burden of cardiovascular disease and stroke in the United States through 2050: a presidential advisory from the American Heart Association. Circulation. 2024;150(4):e89-e101.\u003c/li\u003e\n\u003cli\u003eSnipelisky D, Chaudhry S-P, Stewart GC. The many faces of heart failure. Cardiac electrophysiology clinics. 2019;11(1):11-20.\u003c/li\u003e\n\u003cli\u003eKwekkeboom KL, Bratzke LC. A systematic review of relaxation, meditation, and guided imagery strategies for symptom management in heart failure. Journal of Cardiovascular Nursing. 2016;31(5):457-68.\u003c/li\u003e\n\u003cli\u003eFini A, Cruz DdALMd. Characteristics of fatigue in heart failure patients: a literature review. Revista latino-americana de enfermagem. 2009;17:557-65.\u003c/li\u003e\n\u003cli\u003ePavlovic NV, Gilotra NA, Lee CS, Ndumele C, Mammos D, Dennisonhimmelfarb C, et al. Fatigue in persons with heart failure: a systematic literature review and meta-synthesis using the biopsychosocial model of health. Journal of cardiac failure. 2022;28(2):283-315.\u003c/li\u003e\n\u003cli\u003eWhitehead L. The family experience of fatigue in heart failure. Journal of Family Nursing. 2017;23(1):138-56.\u003c/li\u003e\n\u003cli\u003eBiałek K, Sadowski M. Caregivers\u0026rsquo; burden and other selected problems of patients treated for heart failure. Medical Studies/Studia Medyczne. 2019;35(1):82-8.\u003c/li\u003e\n\u003cli\u003eBaert A. Sexual activity and health-related quality of life in heart failure: an exploration of the patients\u0026rsquo; and healthcare providers\u0026rsquo; perspective: Ghent University; 2019.\u003c/li\u003e\n\u003cli\u003eAbdollahi E, Shokrgozar S, Sheerojan M, Golshahi M, Zare R. Relationship between sexual satisfaction and mental health in married older women. Journal of Guilan University of Medical Sciences. 2021;30(1):14-27.\u003c/li\u003e\n\u003cli\u003ePourghane P, Amiri Nejad P, Razavi Tousi SMT. Effect of cardiac rehabilitation on sexual satisfaction of patients after coronary artery bypass graft surgery. Journal of Guilan University of Medical Sciences. 2021;30(1):2-13.\u003c/li\u003e\n\u003cli\u003eAlhani F. Design and evaluation of family-centered empowerment model to prevent iron deficiency anemia. Tehran: Tarbiat Modarres University. 2003.\u003c/li\u003e\n\u003cli\u003eMousaei FM, Mirhosseini S, Mafi MH, G\u0026uuml;naydın N, Zendehtalab HR. Effect of support based on family centered empowerment model on care burden in family caregivers of patients with multiple sclerosis. Frontiers in Public Health. 2023;11:1115311.\u003c/li\u003e\n\u003cli\u003eKiani F, Salmani F, Azarbarzin M. Effect of an Intervention Based on the Family-centered Empowerment Model on the Resilience of Family Caregivers of Hemodialysis Patients: A Randomized Controlled Clinical Trial. Qom Univ Med Sci J. 2023;16(10):844-57.\u003c/li\u003e\n\u003cli\u003eAlotaibi WMA, Al Otaibi JM, Almutairi SSM, Alrsheedi AAA, Alshlwi MSM, Alanazi ABA, et al. The Role and Impact of Telemedicine in Modern Nursing Practice: Advancements, Benefits, and Challenges in Patient Care. Journal of International Crisis and Risk Communication Research. 2024;7(S3):57.\u003c/li\u003e\n\u003cli\u003eMamashli L. Telenursing in cardiovascular diseases: a critical review of systematic reviews of evidence. Iranian Journal of Systematic Review in Medical Sciences. 2023;1(3):20-32.\u003c/li\u003e\n\u003cli\u003eAriyanto H, Rosa EM. Effectiveness of telenursing in improving quality of life in patients with heart failure: A systematic review and meta-analysis. Journal of Taibah University Medical Sciences. 2024;19(3):664-76.\u003c/li\u003e\n\u003cli\u003eKim YJ, Radloff JC, Crane PA, Bolin LP. Rehabilitation intervention for individuals with heart failure and fatigue to reduce fatigue impact: A feasibility study. Annals of Rehabilitation Medicine. 2019;43(6):686-99.\u003c/li\u003e\n\u003cli\u003eZiaeirad M, Ziaei G, Mohammady M. Correlation of fatigue intensity with demographic and clinical characteristics of patients with congestive heart failure. 2017.\u003c/li\u003e\n\u003cli\u003eNavidhamidi M, Salehi T, Ranjbar H, Alipoor F. Relationship of marital satisfaction and self-care behavior in people with. Iranian Journal of Cardiovascular Nursing. 2019;8(1):110-9.\u003c/li\u003e\n\u003cli\u003eLarson JH, Anderson SM, Holman TB, Niemann BK. A longitudinal study of the effects of premarital communication, relationship stability, and self-esteem on sexual satisfaction in the first year of marriage. Journal of sex \u0026amp; marital therapy. 1998;24(3):193-206.\u003c/li\u003e\n\u003cli\u003eBahrami N, Yaghoobzadeh A, Nia HS, Soliemani M, Haghdoost A. Psychometric properties of the Persian version of Larson\u0026apos;s sexual satisfaction questionnaire in a sample of Iranian infertile couples. 2016.\u003c/li\u003e\n\u003cli\u003eSmets E, Garssen B, Bonke Bd, De Haes J. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. Journal of psychosomatic research. 1995;39(3):315-25.\u003c/li\u003e\n\u003cli\u003eSaffari M, Naderi MK, Piper CN, Koenig HG. Multidimensional fatigue inventory in people with hepatitis B infection: cross-cultural adaptation and psychometric evaluation of the Persian version. Gastroenterology nursing. 2017;40(5):380-92.\u003c/li\u003e\n\u003cli\u003eZiaeirad M, Davari Dolatabadi E, Ziaei G. The effect of applying energy conservation techniques in daily activities on the fatigue of patients with heart failure. Nursing and Midwifery Journal. 2017;14(12):1003-12.\u003c/li\u003e\n\u003cli\u003eRakhshan M, Toufigh A, Dehghani A, Yaktatalab S. Effect of cardiac rehabilitation on sexual satisfaction among patients after coronary artery bypass graft surgery. Journal of Cardiopulmonary Rehabilitation and Prevention. 2019;39(6):E26-E30.\u003c/li\u003e\n\u003cli\u003eNagatomi Y, Ide T, Higuchi T, Nezu T, Fujino T, Tohyama T, et al. Home‐based cardiac rehabilitation using information and communication technology for heart failure patients with frailty. ESC heart failure. 2022;9(4):2407-18.\u003c/li\u003e\n\u003cli\u003eRabeipoor S, Khademvatani K, Barjasteh S, Ghafuri D. Investigating the impact of couple counseling based on the CHARMS model on sexual quality of life and marital satisfaction of wives of men suffering from myocardial infarction: a study protocol. Reproductive Health. 2024;21(1):55.\u003c/li\u003e\n\u003cli\u003eCorona G, Vena W, Pizzocaro A, Salvio G, Sparano C, Sforza A, et al. Anti-hypertensive medications and erectile dysfunction: focus on \u0026beta;-blockers. Endocrine. 2025;87(1):11-26.\u003c/li\u003e\n\u003cli\u003eBaert A, Pardaens S, De Smedt D, Puddu PE, Ciancarelli MC, Dawodu A, et al. Sexual activity in heart failure patients: information needs and association with health-related quality of life. International journal of environmental research and public health. 2019;16(9):1570.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 5 are available in the Supplementary Files section\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-cardiovascular-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bcar","sideBox":"Learn more about [BMC Cardiovascular Disorders](http://bmccardiovascdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bcar/default.aspx","title":"BMC Cardiovascular Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"heart failure, family-centered empowerment, fatigue, sexual satisfaction, telenursing","lastPublishedDoi":"10.21203/rs.3.rs-7623533/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7623533/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHeart failure (HF) is a chronic and progressive disease with extensive physical and psychological sequelae that affects not only patients but also their partners’ quality of life (QoL). This study aimed to determine the effects of telenursing-based family-centered empowerment (TFE) on the level of fatigue and sexual satisfaction of HF patients and their partners.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and Methods:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis randomized clinical trial (RCT) was performed between February and June 2025 on a total of 100 participants (50 patients and 50 partners). The participants were randomly assigned to experimental and control groups. The experimental group received family-centered empowerment (FE) training via the WhatsApp platform for six weeks, followed by two-week telephone follow-up. However, the control group received only routine care. Data were collected via the Smets’ Multidimensional Fatigue Inventory (MFI) and Hudson’s Index of Sexual Satisfaction (ISS) before and eight weeks after the intervention and analyzed via appropriate statistical tests in SPSS version 25.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFindings:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe findings revealed that implementing the TFE intervention caused patients in the experimental group to experience a significant reduction in physical and mental fatigue and reduced activity components (P \u0026lt; 0.05). For the sexual satisfaction variable, only the two \"quality of sexual life\" and \"sexual attitude\" components significantly differed in the inter and intragroup analyses.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe results of this study demonstrate that TFE is an effective approach for reducing fatigue in HF patients, improving the sexual satisfaction level of their partners, and can be used as part of care and rehabilitation programs for these patients and their partners.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis study was prospectively registered in the Iranian Registry of Clinical Trials (IRCT) on January 28, 2025, under the registration number IRCT20241231064226N1. https://www.irct.ir/trial/64226\u003c/p\u003e","manuscriptTitle":"Effects of Telenursing-Based Family Centered Empowerment on the Fatigue and Sexual Satisfaction of Heart Failure Patients and Their Partners: A Randomized Controled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-11-06 16:51:43","doi":"10.21203/rs.3.rs-7623533/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2025-11-13T01:34:24+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"172096154248471575381657846940412727469","date":"2025-11-10T01:28:28+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-11-04T13:22:28+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"319551935485351937105893692801456375278","date":"2025-10-28T06:00:38+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"246321355988996484531958603450246901315","date":"2025-10-27T17:28:27+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-27T16:38:02+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-20T11:00:31+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-09-29T06:27:45+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-09-27T17:50:21+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Cardiovascular Disorders","date":"2025-09-27T11:13:02+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-cardiovascular-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bcar","sideBox":"Learn more about [BMC Cardiovascular Disorders](http://bmccardiovascdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bcar/default.aspx","title":"BMC Cardiovascular Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"dd8ffd48-9547-4ed6-a0d3-09358ce3888a","owner":[],"postedDate":"November 6th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-11-06T16:51:43+00:00","versionOfRecord":[],"versionCreatedAt":"2025-11-06 16:51:43","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7623533","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7623533","identity":"rs-7623533","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}