NCT02158741

Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes

A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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?

Conditions

• Type 2 Diabetes Mellitus
• NIDDM
• Non-insulin Dependent Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Home Visits and Lifestyle Education Support

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-06-09
• Last updated: 2019-08-30

Locations

8 sites across 1 country: Canada