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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Other: diabetes self management support

Detailed Description

Diabetes self management support is telephonic and will be provided by health navigators at a central call center

• Study Type: Interventional
• Enrollment (Actual): 449
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85701
      • El Rio Community Health Center
  • Missouri
    • Cape Girardeau, Missouri, United States, 63703
      • Cross Trails Medical Center
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Triad Adult and Pediatric Medicine, Inc.
  • West Virginia
    • Scott Depot, West Virginia, United States, 25560
      • FamilyCare Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care; usual care includes diabetes self management education
Active Comparator: diabetes self management support; diabetes self management support in addition to usual care, which includes diabetes self management education	Other: diabetes self management support; diabetes self management support is telephonic and provided by health investigators

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: American Association of Diabetes Educators
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Dawn Sherr, MS, RD, CDE, American Association of Diabetes Educators

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: June 6, 2014
• First Submitted That Met QC Criteria: June 9, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: type 2 diabetes; diabetes self management education; diabetes self management support
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BMS-DSMES-2014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No