Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus Type 2
- Sponsor
- American Association of Diabetes Educators
- Enrollment
- 449
- Locations
- 4
- Primary Endpoint
- Change from baseline HbA1c at 3, 9, 15, and 27 months
- Last Updated
- 9 years ago
Overview
Brief Summary
Improving diabetes social support is associated with health improvement benefits. This study is a prospective randomized controlled trial comparing the effects of telephone-based diabetes self-management support (DSMS) compared with usual care, which includes diabetes self-management education (DSME), during a 1-year period. It will determine whether this specific model for providing on-going support to people with diabetes will better enable them to maintain the engagement in self-care behaviors, clinical improvements and diabetes-specific knowledge gained during the course of diabetes self-management education.
Detailed Description
Diabetes self management support is telephonic and will be provided by health navigators at a central call center
Investigators
Eligibility Criteria
Inclusion Criteria
- •English or Spanish speaking
- •Diagnosis of type 2 diabetes mellitus
- •HbA1c \> 8
- •Have not completed a diabetes self management education program in the past year
Exclusion Criteria
- •Current engagement in cancer treatment
- •Diagnosis of end-stage renal disease
- •Receiving immunosuppressant therapy following transplant
- •Diagnosis of serious mental illness
- •Undergoing systemic treatment with prednisone
Outcomes
Primary Outcomes
Change from baseline HbA1c at 3, 9, 15, and 27 months
Time Frame: 0, 3, 9, 15, and 27 months
HbA1c assessment
Change from baseline blood pressure at 3, 9, 15, and 27 months
Time Frame: 0, 3, 9, 15, and 27 months
blood pressure assessments
Change from baseline cholesterol at 3, 9, 15, and 27 months
Time Frame: 0, 3, 9, 15, and 27 months
cholesterol assessments
Change from baseline BMI at 3, 9, 15, and 27 months
Time Frame: 0, 3, 9, 15, and 27 months
body mass index (BMI) assessments
Change from baseline weight at 3, 9, 15, and 27 months
Time Frame: 0, 3, 9, 15, and 27 months
weight assessments
Change from baseline fasting glucose at 3, 9, 15, and 27 months
Time Frame: 0, 3, 9, 15, and 27 months
fasting glucose assessments
Secondary Outcomes
- Change from baseline patient credential at 3, 9, 15, and 27 months(0, 3, 9, 15, and 27 months)
- Change from baseline depression at 3, 9, 15, and 27 months(0, 3, 9, 15, and 27 months)
- Change from baseline food security at 3, 9, 15, and 27 months(0, 3, 9, 15, and 27 months)