The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial

Abstract

BackgroundMany community-based self-management programs have been developed for older adults with type-2 diabetes mellitus (T2DM), bolstered by evidence from randomized controlled trials (RCTs) that T2DM can be prevented and managed through lifestyle modifications. However, the evidence for their effectiveness is contradictory and weakened by reliance on single-group designs and/or small samples. Additionally, older adults with multiple chronic conditions (MCC) are often excluded because of recruiting and retention challenges. This paper presents a protocol for a two-armed, multisite, pragmatic, mixed-methods RCT examining the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP), a new 6-month interprofessional, nurse-led program to promote self-management in older adults (aged 65 years or older) with T2DM and MCC and support their caregivers (including family and friends).Methods/designThe study will enroll 160 participants in two Canadian provinces, Ontario and Alberta. Participants will be randomly assigned to the control (usual care) or program study arm. The program will be delivered by registered nurses (RNs) and registered dietitians (RDs) from participating diabetes education centers (Ontario) or primary care networks (Alberta) and program coordinators from partnering community-based organizations. The 6-month program includes three in-home visits, monthly group sessions, monthly team meetings for providers, and nurse-led care coordination. The primary outcome is the change in physical functioning as measured by the Physical Component Summary (PCS-12) score from the short form-12v2 health survey (SF-12). Secondary client outcomes include changes in mental functioning, depressive symptoms, anxiety, and self-efficacy. Caregiver outcomes include health-related quality of life and depressive symptoms. The study includes a comparison of health care service costs for the intervention and control groups, and a subgroup analysis to determine which clients benefit the most from the program. Descriptive and qualitative data will be collected to examine implementation of the program and effects on interprofessional/team collaboration.DiscussionThis study will provide evidence of the effectiveness of a community-based self-management program for a complex target population. By studying both implementation and effectiveness, we hope to improve the uptake of the program within the existing community-based structures, and reduce the research-to-practice gap.Trial registrationClinicalTrials.gov, Identifier: NCT02158741. Registered on 3 June 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1795-9) contains supplementary material, which is available to authorized users.

Factors Determining the Success of Therapeutic Lifestyle Interventions in Diabetes – Role of Partner and Family Support

“…37 Finally, it enhances motivational skills for self-sufficiency, positive behaviours and independent attitudes towards disease. 39–41…”

Community Program Improves Quality of Life and Self‐Management in Older Adults with Diabetes Mellitus and Comorbidity

“…Details regarding design and outcome measures are described in the study protocol. 19 HRQoL, mental health, self-efficacy, and self-management outcomes were selected based on effects evidence from T2DM self-management intervention reviews and metaanalyses. [24][25][26] Trained research assistants obtained outcome data at baseline and 6 months after the intervention.…”

Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial

“…The effectiveness of a 6-month self-management program for community-dwelling older adults with T2DM and MCC was assessed in comparison to a control group receiving usual care. Details of the study design and outcomes are reported in the published study protocol [19].…”

“…Details regarding outcome measures are described in the study protocol [19]. The primary study outcome was the Physical Component Summary (PCS) score from the 12item Medical Outcomes Study Short Form-12v1 Health Survey (SF-12) [29].…”

“…This paper presents the results of a trial that addresses these current gaps in the diabetes literature. It reports the results for the Alberta arm of a multisite pragmatic RCT examining whether a 6-month self-management program for older adults with T2DM and multimorbidity was more effective in improving health outcomes than usual care [19]. Results from the pilot study and Ontario arm of this trial are reported elsewhere [20,21].…”