Effectiveness of the Aging, Community and Health Research Unit’s Community Partnership Program (ACHRU-CPP) for Older Adults with Diabetes and Multiple Chronic Conditions: A Multi-Site, Pragmatic Randomized Controlled Trial

Abstract

Background: Modifiable risk factors for type 2 diabetes are primarily lifestyle related. However, we know little about the impact of low-intensity community-based lifestyle interventions on health and health services use. In this patient-oriented research, we sought to assess the effectiveness on quality of life of a 6-month, person-centred community-based lifestyle intervention (additional to usual care) for community-dwelling older adults (≥ 65 years) with diabetes and at least one other chronic condition, and their caregivers compared to usual care. Methods: We conducted a type II hybrid effectiveness-implementation randomized controlled trial (RCT) at two sites in each of three Canadian provinces. Knowledge user partners were engaged throughout. Participants were eligible if aged 65+ years, diagnosed with diabetes and multimorbidity, enrolled in a primary care setting or diabetes education program, capable of providing consent, and spoke English or French. Enrolled participants were randomly assigned to intervention and control arms (1:1). The intervention arm consisted of usual care plus: 1) up to 3 home/telephone visits; 2) up to 6 monthly group education sessions; 3) ongoing nurse-led care coordination and system navigation; 4) caregiver engagement/support; 5) monthly interdisciplinary team case conferences; and 6) collaboration with primary care, as needed. The control arm received usual care. The primary outcome was quality of life (measure: SF-12 Mental Component Summary [MCS]); intention-to-treat was used with missing data multiply imputed. Secondary outcomes and sensitivity analyses were tested. Results: The trial ran from July 2019 - May 2022; sites started at different points within this period. Of 619 eligible participants, 295 (48%) were enrolled and 246 (83%) completed 6-month data collection. Our primary analysis showed no difference between groups in the SF12-MCS (mean difference: ?0.71, 95% CI ?2.66 to 1.24, p = 0.47) or secondary outcomes (e.g., anxiety, self-care, physical activity); sensitivity analyses showed consistent results. Discussion: A low intensity 6-month community-based lifestyle intervention for community-dwelling older adults (≥65 years) with diabetes and at least one other chronic condition did not improve quality of life or other outcomes, in contrast to our previous studies. The trial ran during COVID-19, with disruptions and the shift to virtual delivery potentially diluting intervention effects.