Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT02158741|
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : May 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus NIDDM Non-insulin Dependent Diabetes Mellitus||Behavioral: Home Visits and Lifestyle Education Support||Not Applicable|
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?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||291 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (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|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
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|
- Summary of Diabetes Self-Care Activities [ Time Frame: Every two months from study onset until the end of study (6 months from baseline) ]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) ]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) ]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) ]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 ]• 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158741
|Edmonton Oliver PCN|
|Edmonton, Alberta, Canada|
|Leduc Beaumont Devon PCN|
|Leduc, Alberta, Canada, T9E 6W2|
|Sherwood Park PCN|
|Sherwood Park, Alberta, Canada|
|Hamilton, Ontario, Canada, L8S 4K1|
|Ross Memorial Hospital|
|Lindsay, Ontario, Canada|
|St. Joseph's Health Care|
|London, Ontario, Canada|
|Peterborough Regional Health Centre|
|Peterborough, Ontario, Canada|
|Port Hope Community Health Centre|
|Port Hope, Ontario, Canada|
|Principal Investigator:||Maureen Markle-Reid, PhD||McMaster University|
|Principal Investigator:||Jenny Ploeg, PhD||McMaster University|