Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes
The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers. Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.
Type 2 Diabetes Mellitus
Non-insulin Dependent Diabetes Mellitus
Behavioral: Home Visits and Lifestyle Education Support
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions|
- Summary of Diabetes Self-Care Activities [ Time Frame: Every two months from study onset until the end of study (6 months from baseline) ] [ Designated as safety issue: No ]The SDSCA is a multidimensional measure of diabetes self-management with adequate internal and test-retest reliability, and evidence of validity and sensitivity to change. The revised SDSCA consists of items that assess the following aspects of the diabetes regimen: general and specific diet, exercise, blood-glucose testing, foot care, and smoking. Scores are calculated for each of these five regimen areas. This data is collected by the interventionists at each visit.
- SF12v2 [ Time Frame: Baseline and end of study (6 months from baseline) ] [ Designated as safety issue: No ]This measurement is used to assess Health related quality of Life. This survey consists of 12 questions that measure functional health and well-being from the client's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health), and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores
- CES-D-10 [ Time Frame: Baseline and end of study (6 months from baseline) ] [ Designated as safety issue: No ]The CES-D has been used in prior studies of older adults with mood disorders, and has a high degree of reliability, content, construct and criterion related validity, distinguishes between depressed and non-depressed people, and is a sensitive tool for measuring changes in depressive symptoms over time in psychiatric populations.
- GAD-7 [ Time Frame: Baseline and end of study (6 months from baseline) ] [ Designated as safety issue: No ]Prevalence and severity of anxiety, measured by the Generalized Anxiety Disorder Screener
- Health Assessment forms [ Time Frame: Baseline intervention interview, at 3 months and again at 6 months ] [ Designated as safety issue: No ]• Diabetes parameters (fasting blood glucose, HbA1c, hypoglycemic episodes), and presence of diabetes-related complications and comorbid chronic conditions, obtained from health assessment forms submitted by the Diabetes Education Program RN and RD after the first home visit and at 3 months and 6 months.
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
No Intervention: Usual Primary Care
Usual Primary Care will be received by half the participants during the course of the Study
Active Comparator: Home Visits and educational support
Intervention comprised of Home Visits and group educational sessions. Home Visits and will be conducted by Diabetes Education staff in lieu of usual care conducted at the Diabetes clinic. Lifestyle support and educational will be offered in the form of monthly Diabetes Wellness Days offered in the community where nutrition, exercise and support will be given to help improve self-management of diabetes.
|Behavioral: Home Visits and Lifestyle Education Support|
To examine the comparative effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with T2DM and Multiple Chronic Conditions and their family caregivers.
- To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services?
- To compare the effectiveness of the intervention on HRQoL, physical activity, nutritional status, depression, anxiety, diabetes parameters (blood glucose levels [HbA1c, hypoglycemic episodes]), diabetes-related complications, number of vascular events, social support number of falls, fall risk and medication safety with usual primary care services?
- To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care?
- To assess whether or not the intervention improves clinical practice behaviours?
- To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective?
- To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention?
- To determine the effectiveness of the intervention based on sex/gender and region?
- To determine the overall feasibility and acceptability of an IP community-based health promotion intervention and what can be identified as barriers and facilitators to implementation?
Please refer to this study by its ClinicalTrials.gov identifier: NCT02158741
|Contact: Amy Bartholomew, RN, BScN||905-525-9140 ext email@example.com|
|McMaster University||Not yet recruiting|
|Hamilton, Ontario, Canada, L8S 4K1|
|Contact: Amy Bartholomew, RN, BScN 905-525-9140 ext 20294 firstname.lastname@example.org|
|Principal Investigator: Maureen Markle-Reid, PhD|
|Sub-Investigator: Jenny Ploeg, PhD|
|Principal Investigator:||Maureen Markle-Reid, PhD||McMaster University|
|Principal Investigator:||Ross Upshur, MD||University of Toronto|