Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03664583
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-31
First Post:
2018-08-23
Brief Title:
ACHRU Community Partnership Program for Diabetes Self-Management for Older Adults - Canada
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
ACHRU Community Partnership Program for Diabetes Self-Management for Older Adults - Canada
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACHRU-CPP
Brief Summary:
Living with diabetes and other chronic ongoing conditions is common in older adults These individuals have poorer health and higher use of health services compared to older adults with diabetes alone Programs that help older adults self-manage their diabetes and other health conditions benefit both individuals and the healthcare system The McMaster University Aging Community and Health Research Unit developed and tested a new patient-centered community-based program CPP to improve the delivery and outcomes of care for older adults with diabetes and other chronic conditions This 6-month program was developed in partnership with patients caregivers primary and community care providers and researchers The program is delivered by nurses dietitians and community providers It involves in-home or virtual visits by nurses and dietitians monthly group wellness sessions at community centers or virtually and monthly virtual team meetings Wellness sessions include exercise education and social support Caregivers are invited to be active participants along with patients The program was successfully implemented in Ontario and Alberta Participants who received the program had better quality of life self-management and mental health at no additional cost from a societal perspective compared to those receiving usual care To determine how the program can best help people more testing is needed with different communities and groups of people We will partner with primary healthcare teams eg family doctors offices in three provinces to adapt and test the program in a variety of real-world settings We will assess how to best put this program into practice and measure outcomes important to patients and caregivers so study results are relevant to them Study findings will guide the development of a plan for expanding the program to reach and benefit more older adults with diabetes and other chronic health conditions Patients and caregivers will be involved as key partners in all aspects of the research
Detailed Description:
The purpose of this study is to examine the implementation and effectiveness of the CPP intervention in new settings and populations to demonstrate widespread effectiveness and ways to adapt CPP for diverse population subgroups and primary care setting and community care contexts Based on the investigators previous work we expect that the CPP intervention will result in a greater improvement in mental health and will be cost neutral relative to usual care because program costs will be offset by lower use of other health services A cross-jurisdictional multi-site implementation-effectiveness type II hybrid randomized controlled trial will be conducted The trial will be conducted in two sites in each of Ontario Quebec and Prince Edward Island Each of the six sites will involve a primary care setting and a community care organization Study participants will be randomly assigned to the intervention or usual care group Participants randomly assigned to the intervention group will be offered the 6-month CPP intervention in addition to their usual primary care services offered by their local diabetes education centre or primary care setting The primary outcome of intervention effectiveness is patient mental health Other health outcomes for patients and their caregivers will be assessed eg depression anxiety use of health and social services etc Implementation will be examined in-detail through qualitative evaluations with providers patients and caregivers Engagement of patients and caregivers will occur in all stages of the research study Qualitative evaluation of patients and caregivers as research partners will be conducted through annual evaluations Patient Public eg caregivers knowledge users and Community eg local providersrepresentatives Research Partners will be engaged in the research study by way of the studys established governance structures Community Advisory Boards Patient Advisory Council and Steering Committee Qualitative evaluation of Patient Public and Community Research Partners will be conducted to inform implementation of the CPP intervention at the local context and the potential for widespread implementation and scale-up Both quantitative and qualitative evaluations will be used to interpret study findings and in the development of scale-up plans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None