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 trialReportar como inadecuado




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Trials

, 18:55

First Online: 06 February 2017Received: 06 July 2016Accepted: 11 January 2017DOI: 10.1186-s13063-017-1795-9

Cite this article as: Markle-Reid, M., Ploeg, J., Fraser, K.D. et al. Trials 2017 18: 55. doi:10.1186-s13063-017-1795-9

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.

KeywordsType-2 diabetes mellitus Randomized controlled trial Pragmatic Hybrid effectiveness-implementation design Self-management Group-based programs Community-based settings Health-related quality of life Older adults AbbreviationsACHRUAging, Community and Health Research Unit McMaster University

ACHRU-CPPAging, Community and Health Research Unit-Community Partnership Program

CES-D-10Center for Epidemiological Studies on Depression 10 items

CFIRConsolidated Framework for Implementation Research

CSIModified Caregiver Strain Index

DECDiabetes Education Center

DPPDiabetes Prevention Program

FDPSFinnish Diabetes Prevention Study

GAD-7Generalized Anxiety Disorder 7 items

HiREBHamilton Integrated Research Ethics Board

HRQoLHealth-related quality of life

HSSUIHealth and Social Services Utilization Inventory

MCCMultiple chronic conditions

MCS-12Mental Component Summary Score SF-12

MIDMinimally important difference

PCProgram coordinator

PCNPrimary Care Network

PCS-12Physical Component Summary Score SF-12

RAResearch assistant

RCTRandomized control trial

RDRegistered dietitian

RNRegistered nurse

SDSCASummary of Diabetes Self Care Activities

SF-12Short-Form Health Survey 12 items

T2DMType-2 diabetes mellitus

TCITeam Climate Inventory

YMCAYoung Men’s Christian Association

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-017-1795-9 contains supplementary material, which is available to authorized users.





Autor: Maureen Markle-Reid - Jenny Ploeg - Kimberly D. Fraser - Kathryn Ann Fisher - Noori Akhtar-Danesh - Amy Bartholomew - Amir

Fuente: https://link.springer.com/







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