Journal Article

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

Ganann, Rebecca, Poitras, Marie-Eve, Blais, Johanne, Paquette, Jean-Sébastien, Fisher, Kathryn, Légaré, France, MacIntyre, Janet, Ploeg, Jenny, Chambers, Tracey, Yous, Marie-Lee, Valaitis, Ruta, Connors, Robyn, Montelpare, William, Gruneir, Andrea, Markle-Reid, Maureen, Riveroll, Angela

2022

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Activities of daily living / Adaptation / Aged / Aging / Care and treatment / Caregivers / Chronic diseases / Chronic illnesses / Clinical trials / Community health services / Comorbidity / Coronaviruses / Cost-Benefit Analysis / Costs / COVID-19 / Demographic aspects / Diabetes / Diabetes mellitus (insulin dependent) / Diabetes Mellitus - diagnosis / Diabetes Mellitus - therapy / Diabetes therapy / Geriatrics / Geriatrics/Gerontology / Health care / Health services / Humans / Intervention / Medical research / Medicine / Medicine & Public Health / Mental health / Methods / Multiple Chronic Conditions / Older adults / Older people / Patient education / Patient-oriented intervention / Planning / Pragmatic Clinical Trials as Topic / Pragmatic effectiveness-implementation trial / Primary care / Quality of Life / Randomized Controlled Trials as Topic / Rehabilitation / Self-care, Health / Self-management / Socioeconomic factors / Study Protocol / Systematic review