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.
Many 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).



The 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.



This 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.



ClinicalTrials.gov, Identifier: NCT02158741 . Registered on 3 June 2014.
Aging, Community and Health Research Unit (ACHRU), School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. mreid@mcmaster.ca.
Maureen
M
Markle-Reid
Aging, Community and Health Research Unit (ACHRU), School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Jenny
J
Ploeg
Faculty of Nursing, University of Alberta, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada.
Kimberly D
KD
Fraser
Aging, Community and Health Research Unit (ACHRU), School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Kathryn Ann
KA
Fisher
School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Noori
N
Akhtar-Danesh
Aging, Community and Health Research Unit (ACHRU), School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Amy
A
Bartholomew
Department of Clinical Epidemiology and Biostatistics, Centre for Health Economics and Policy Analysis, McMaster University, 1280 Main Street, Hamilton, ON, L8S 4K1, Canada.
Amiram
A
Gafni
Department of Family Medicine, University of Alberta, 6-40 University Terrace, Edmonton, AB, T6G 2T4, Canada.
Andrea
A
Gruneir
Faculty of Nursing, University of Calgary, 2500 University Drive NW, Calgary, AB, T2N 1N4, Canada.
Sandra P
SP
Hirst
School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Sharon
S
Kaasalainen
Aging, Community and Health Research Unit (ACHRU), School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.
Caralyn Kelly
CK
Stradiotto
Faculty of Nursing, University of Alberta, 11405-87 Avenue, Edmonton, AB, T6G 1C9, Canada.
John
J
Miklavcic
Department of Family Medicine, McMaster School of Medicine, Principal, CRF Consulting, 763 Cedar Bend Drive, Waterloo, ON, N2V 2R6, Canada.
Carlos
C
Rojas-Fernandez
Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, 3-229 Edmonton Clinic Health Academy, 11405 87 Avenue, Edmonton, AB, T6G 1C9, Canada.
Cheryl A
CA
Sadowski
Department of Clinical Epidemiology and Biostatistics, St. Joseph's Healthcare Hamilton, Room H-325, 50 Charlton Avenue East, Hamilton, ON, L8N 4A6, Canada.
Lehana
L
Thabane
Care of the Elderly Division, Department of Family Medicine, University of Alberta, Edmonton, AB, T6G 2R7, Canada.
Jean A C
JA
Triscott
Division of Clinical Public Health, Dalla Lana School of Public Health, University of Toronto, 155 College Street, 6th floor, Toronto, ON, M5T 3M7, Canada.
Ross
R
Upshur
D000367:Age Factors; D000368:Aged; D000375:Aging / Q000523:psychology*; D000416:Alberta; D017028:Caregivers / Q000191:economics / Q000523:psychology*; D002985:Clinical Protocols; D003153:Community Health Services / Q000191:economics; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000191:economics / Q000451:nursing* / Q000523:psychology; D005260:Female; D017048:Health Care Costs; D000070497:Healthy Lifestyle; D006801:Humans; D008297:Male; D000071069:Multiple Chronic Conditions / Q000191:economics / Q000451:nursing* / Q000523:psychology; D009864:Ontario; D011788:Quality of Life; D012107:Research Design; D040242:Risk Reduction Behavior; D012648:Self Care / Q000191:economics / Q000379:methods* / Q000523:psychology; D012944:Social Support; D013997:Time Factors; D016896:Treatment Outcome
Community-based settings; Group-based programs; Health-related quality of life; Hybrid effectiveness-implementation design; Older adults; Pragmatic; Randomized controlled trial; Self-management; Type-2 diabetes mellitus