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Background Studies have shown the existence of health concordance between patients with type 2 diabetes mellitus (T2DM) and their spouses, and also that spouses could influence the effect of self-management, benefiting patients’ health. However, these studies are heterogeneous and the evidence is inconclusive. Objective To synthesize evidence from published randomized controlled trials: the interventional effects and the quality of study performance, also to identify the research gap and the directions for future studies. Methods We performed the scoping review by following the PRISMA-ScR guidance. We searched and examined the reports from MEDLINE, EMBASE, PsychInfo, CINAHL Plus by the pre-specified criteria. Key characteristics and information of eligible reports were extracted, analysed and synthesized comprehensively, and the results were presented in the form of words and diagrams. Results We identified 5 reports from 4 studies out of 3479 records included. Qualified studies indicated a positive effect of couple-based interventions on couples’ distress. Insufficient evidence on physiological health or health behaviours was identified owing to the small number of included studies and inconsistent assessment outcomes. The methodological quality across these studies was generally low due to inadequate reporting of study process and substantial biases. Conclusions Couple-based interventions for patients with T2DM showed small effects on the couple’s distress while the effects of other outcomes were inconclusive. Future studies should strengthen methodologies by using standard measures of core diabetic outcomes, including detailed assessments of implementation process, and taking a dyadic approach to systematically examine the effects.

Background China’s limited health care resources cannot meet the needs of chronic disease treatment and management of its rapid growing ageing population. The improvement and maintenance of patient’s self-management is essential to disease management. Given disease management mainly occurs in the context of family, this study proposes to validate a Couple-based Collaborative Management Model of chronic diseases that integrates health professionals and family supporters; such as to empower the couples with disease management knowledge and skills, and to improve the couples’ health and quality of life. Methods The proposed study will validate a couple-based collaborative management model of Type 2 Diabetes Mellitus (T2DM) in a community-based multicenter, two-arm, randomized controlled trial of block design in Guangzhou, China. Specifically, 194 T2DM patients aged ≥55 and their partners recruited from community health care centers will be randomized at the patient level for each center at a 1:1 ratio into the couple-based intervention arm and the individual-based control arm. For the intervention arm, both the patients and their spouses will receive four-weekly structured group education & training sessions and 2 months of weekly tailored behavior change boosters; while these interventions will be only provided to the patients in the control group. Behavior change incentives will be targeted at the couples or only at the patient respectively. Treatment effects on patients’ hemoglobin, spouses’ quality of life, alongside couples’ behavior outcomes will be compared between arms. Study implementation will be evaluated considering its Reach, Effectiveness, Adoption, Implementation and Maintenance following the RE-AIM framework. Discussion This study will generate a model of effective collaboration between community health professionals and patients’ family, which will shield light on chronic disease management strategy for the increasing ageing population. Trial registration Chinese Clinical Trial Registry, ChiCTR1900027137, Registered 1st Nov. 2019