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- Title
The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP) for older adults with diabetes and multiple chronic conditions: study protocol for a randomized controlled trial.
- Authors
Ploeg, Jenny; Markle-Reid, Maureen; Valaitis, Ruta; Fisher, Kathryn; Ganann, Rebecca; Blais, Johanne; Chambers, Tracey; Connors, Robyn; Gruneir, Andrea; Légaré, France; MacIntyre, Janet; Montelpare, William; Paquette, Jean-Sébastien; Poitras, Marie-Eve; Riveroll, Angela; Yous, Marie-Lee; on behalf of the ACHRU-CPP Research Team; Charif, Ali Ben; Eurich, Dean; Gafni, Amiram
- Abstract
Background: Older adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality. Many community-based self-management interventions have been developed for this group, however the evidence for their effectiveness is limited. This paper presents the protocol for a randomized controlled trial (RCT) comparing the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) to usual care in older adults with diabetes and MCC and their caregivers.Methods: We will conduct a cross-jurisdictional, multi-site implementation-effectiveness type II hybrid RCT. Eligibility criteria are: ≥65 years, diabetes diagnosis (Type 1 or 2) and at least one other chronic condition, and enrolled in a primary care or diabetes education program. Participants will be randomly assigned to the intervention (ACHRU-CPP) or control arm (1:1 ratio). The intervention arm consists of home/telephone visits, monthly group wellness sessions, multidisciplinary case conferences, and system navigation support. It will be delivered by registered nurses and registered dietitians/nutritionists from participating primary care or diabetes education programs and program coordinators from community-based organizations. The control arm consists of usual care provided by the primary care setting or diabetes education program. The primary outcome is the change from baseline to 6 months in mental functioning. Secondary outcomes will include, for example, the change from baseline to 6 months in physical functioning, diabetes self-management, depressive symptoms, and cost of use of healthcare services. Analysis of covariance (ANCOVA) models will be used to analyze all outcomes, with intention-to-treat analysis using multiple imputation to address missing data. Descriptive and qualitative data from older adults, caregivers and intervention teams will be used to examine intervention implementation, site-specific adaptations, and scalability potential.Discussion: An interprofessional intervention supporting self-management may be effective in improving health outcomes and client/caregiver experience and reducing service use and costs in this complex population. This pragmatic trial includes a scalability assessment which considers a range of effectiveness and implementation criteria to inform the future scale-up of the ACHRU-CPP.Trial Registration: Clinical Trials.gov Identifier NCT03664583 . Registration date: September 10, 2018.
- Subjects
OLDER people; RANDOMIZED controlled trials; SCIENTIFIC community; CHRONIC diseases; RESEARCH protocols; NUTRITIONISTS
- Publication
BMC Geriatrics, 2022, Vol 22, Issue 1, p1
- ISSN
1471-2318
- Publication type
Academic Journal
- DOI
10.1186/s12877-021-02651-7