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.
Research Goal 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. Objectives 1. To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services? 2. 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? 3. To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care? 4. To assess whether or not the intervention improves clinical practice behaviours? 5. To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective? 6. To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention? 7. To determine the effectiveness of the intervention based on sex/gender and region? 8. 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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
291
Edmonton Oliver PCN
Edmonton, Alberta, Canada
Leduc Beaumont Devon PCN
Leduc, Alberta, Canada
Sherwood Park PCN
Sherwood Park, Alberta, Canada
McMaster University
Hamilton, Ontario, Canada
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
Summary of Diabetes Self-Care Activities
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.
Time frame: Every two months from study onset until the end of study (6 months from baseline)
SF12v2
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
Time frame: Baseline and end of study (6 months from baseline)
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