Overview

This trial is active, not recruiting.

Condition diabetes mellitus type 2
Treatment diabetes self management support
Sponsor American Association of Diabetes Educators
Collaborator Bristol-Myers Squibb
Start date January 2015
End date May 2017
Trial size 449 participants
Trial identifier NCT02160639, BMS-DSMES-2014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(No Intervention)
usual care includes diabetes self management education
(Active Comparator)
diabetes self management support in addition to usual care, which includes diabetes self management education
diabetes self management support
diabetes self management support is telephonic and provided by health investigators

Primary Outcomes

Measure
Change from baseline HbA1c at 3, 9, 15, and 27 months
time frame: 0, 3, 9, 15, and 27 months
Change from baseline blood pressure at 3, 9, 15, and 27 months
time frame: 0, 3, 9, 15, and 27 months
Change from baseline cholesterol at 3, 9, 15, and 27 months
time frame: 0, 3, 9, 15, and 27 months
Change from baseline BMI at 3, 9, 15, and 27 months
time frame: 0, 3, 9, 15, and 27 months
Change from baseline weight at 3, 9, 15, and 27 months
time frame: 0, 3, 9, 15, and 27 months
Change from baseline fasting glucose at 3, 9, 15, and 27 months
time frame: 0, 3, 9, 15, and 27 months

Secondary Outcomes

Measure
Change from baseline patient credential at 3, 9, 15, and 27 months
time frame: 0, 3, 9, 15, and 27 months
Change from baseline depression at 3, 9, 15, and 27 months
time frame: 0, 3, 9, 15, and 27 months
Change from baseline food security at 3, 9, 15, and 27 months
time frame: 0, 3, 9, 15, and 27 months

Eligibility Criteria

Male or female participants from 21 years up to 85 years old.

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 - Pregnant - Receiving immunosuppressant therapy following transplant - Diagnosis of serious mental illness - Undergoing systemic treatment with prednisone

Additional Information

Official title Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
Principal investigator Dawn Sherr, MS, RD, CDE
Description Diabetes self management support is telephonic and will be provided by health navigators at a central call center
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by American Association of Diabetes Educators.