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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02160639
• Other study ID #: BMS-DSMES-2014
• Status: Active, not recruiting
• Phase: N/A
• First received: June 6, 2014
• Last updated: July 11, 2016
• Start date: January 2015
• Est. completion date: May 2017

Study information

• Verified date: July 2016
• Source: American Association of Diabetes Educators
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 449
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Other:
• diabetes self management support
diabetes self management support is telephonic and provided by health investigators

Locations

Country	Name	City	State
United States	Cross Trails Medical Center	Cape Girardeau	Missouri
United States	Triad Adult and Pediatric Medicine, Inc.	High Point	North Carolina
United States	FamilyCare Health Center	Scott Depot	West Virginia
United States	El Rio Community Health Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
American Association of Diabetes Educators	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline HbA1c at 3, 9, 15, and 27 months	HbA1c assessment	0, 3, 9, 15, and 27 months	No
Primary	Change from baseline blood pressure at 3, 9, 15, and 27 months	blood pressure assessments	0, 3, 9, 15, and 27 months	No
Primary	Change from baseline cholesterol at 3, 9, 15, and 27 months	cholesterol assessments	0, 3, 9, 15, and 27 months	No
Primary	Change from baseline BMI at 3, 9, 15, and 27 months	body mass index (BMI) assessments	0, 3, 9, 15, and 27 months	No
Primary	Change from baseline weight at 3, 9, 15, and 27 months	weight assessments	0, 3, 9, 15, and 27 months	No
Primary	Change from baseline fasting glucose at 3, 9, 15, and 27 months	fasting glucose assessments	0, 3, 9, 15, and 27 months	No
Secondary	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	No
Secondary	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	No
Secondary	Change from baseline food security at 3, 9, 15, and 27 months	Food Security Screening Questionnaire	0, 3, 9, 15, and 27 months	No