Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support

Not Applicable

• Conditions: Diabetes Mellitus Type 2
• Interventions: Other: diabetes self management support

• Registration Number: NCT02160639
• Lead Sponsor: American Association of Diabetes Educators

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

Study Timeline

• Study First Submitted: 2014-06-06
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-11
• Study Start: 2015-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 449

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diabetes self management support	diabetes self management support	diabetes self management support in addition to usual care, which includes diabetes self management education

Primary Outcome Measures

Name	Time	Method
Change from baseline HbA1c at 3, 9, 15, and 27 months	0, 3, 9, 15, and 27 months	HbA1c assessment
Change from baseline blood pressure at 3, 9, 15, and 27 months	0, 3, 9, 15, and 27 months	blood pressure assessments
Change from baseline cholesterol at 3, 9, 15, and 27 months	0, 3, 9, 15, and 27 months	cholesterol assessments
Change from baseline BMI at 3, 9, 15, and 27 months	0, 3, 9, 15, and 27 months	body mass index (BMI) assessments
Change from baseline weight at 3, 9, 15, and 27 months	0, 3, 9, 15, and 27 months	weight assessments
Change from baseline fasting glucose at 3, 9, 15, and 27 months	0, 3, 9, 15, and 27 months	fasting glucose assessments

Secondary Outcome Measures

Name	Time	Method
Change from baseline patient credential at 3, 9, 15, and 27 months	0, 3, 9, 15, and 27 months	Patient Credential for Diabetes Patients developed by American Pharmacists Association Foundation (APhAF)
Change from baseline depression at 3, 9, 15, and 27 months	0, 3, 9, 15, and 27 months	Patient Health Questionnaire 2 Question Screening (PHQ-2)
Change from baseline food security at 3, 9, 15, and 27 months	0, 3, 9, 15, and 27 months	Food Security Screening Questionnaire

Trial Locations

Locations (4)

FamilyCare Health Center; 🇺🇸 Scott Depot, West Virginia, United States

El Rio Community Health Center; 🇺🇸 Tucson, Arizona, United States

Cross Trails Medical Center; 🇺🇸 Cape Girardeau, Missouri, United States

Triad Adult and Pediatric Medicine, Inc.; 🇺🇸 High Point, North Carolina, United States