Self-management interventions for Type 2 Diabetes: systematic review protocol focusing on patient workload and capacity support

Introduction: People living with type 2 diabetes undertake a range of tasks to manage their condition, collectively referred to as self-management. Interventions designed to support self-management vary in their content, and efficacy. This systematic review will analyse self-management interventions for type 2 diabetes drawing on theoretical models of patient workload and capacity. Methods: and analysis: Five electronic databases (Medline, Embase, CENTRAL, CINAHL and PsycINFO) will be searched from inception to 27th April 2021, supplemented by citation searching and hand-searching of reference lists. Two reviewers will independently review titles, abstracts and full texts. Inclusion criteria include Population: Adults with type 2 diabetes mellitus; Intervention: Randomised controlled trials of self-management support interventions; Comparison: Usual care; Outcomes: HbA1c (primary outcome) health-related quality of life (QOL), medication adherence, self-efficacy, treatment burden, healthcare utilization (e.g. number of appointment, hospital admissions), complications of type 2 diabetes (e.g. nephropathy, retinopathy, neuropathy, macrovascular disease) and mortality; Setting: Community. Study quality will be assessed using the Effective Practice and Organisation of Care (EPOC) risk of bias tool. Interventions will be classified according to the EPOC taxonomy and the PRISMS self-management taxonomy and grouped into similar interventions for analysis. Clinical and methodological heterogeneity will be assessed within subgroups, and random effects meta-analyses performed if appropriate. Otherwise, a narrative synthesis will be performed. Interventions will be graded on their likely impact on patient workload and support for patient capacity. The impact of these theoretical constructs on study outcomes will be explored using meta-regression. Conclusion: This review will provide a broad overview of self-management interventions, analysed within the cumulative complexity model theoretical framework. Analyses will explore how the workload associated with self-management, and support for patient capacity, impact on outcomes of self-management interventions. Registration number: PROSPERO CRD42021236980.