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

Primary Purpose

Diabetes Mellitus Type 2

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
diabetes self management support
Sponsored by
American Association of Diabetes Educators
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus Type 2 focused on measuring diabetes self management education, diabetes self management support, type 2 diabetes

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • El Rio Community Health Center
  • Cross Trails Medical Center
  • Triad Adult and Pediatric Medicine, Inc.
  • FamilyCare Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

usual care

diabetes self management support

Arm Description

usual care includes diabetes self management education

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline patient credential at 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
Patient Health Questionnaire 2 Question Screening (PHQ-2)
Change from baseline food security at 3, 9, 15, and 27 months
Food Security Screening Questionnaire

Full Information

First Posted
June 6, 2014
Last Updated
July 11, 2016
Sponsor
American Association of Diabetes Educators
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02160639
Brief Title
Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
Official Title
Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Association of Diabetes Educators
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
diabetes self management education, diabetes self management support, type 2 diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
449 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care
Arm Type
No Intervention
Arm Description
usual care includes diabetes self management education
Arm Title
diabetes self management support
Arm Type
Active Comparator
Arm Description
diabetes self management support in addition to usual care, which includes diabetes self management education
Intervention Type
Other
Intervention Name(s)
diabetes self management support
Intervention Description
diabetes self management support is telephonic and provided by health investigators
Primary Outcome Measure Information:
Title
Change from baseline HbA1c at 3, 9, 15, and 27 months
Description
HbA1c assessment
Time Frame
0, 3, 9, 15, and 27 months
Title
Change from baseline blood pressure at 3, 9, 15, and 27 months
Description
blood pressure assessments
Time Frame
0, 3, 9, 15, and 27 months
Title
Change from baseline cholesterol at 3, 9, 15, and 27 months
Description
cholesterol assessments
Time Frame
0, 3, 9, 15, and 27 months
Title
Change from baseline BMI at 3, 9, 15, and 27 months
Description
body mass index (BMI) assessments
Time Frame
0, 3, 9, 15, and 27 months
Title
Change from baseline weight at 3, 9, 15, and 27 months
Description
weight assessments
Time Frame
0, 3, 9, 15, and 27 months
Title
Change from baseline fasting glucose at 3, 9, 15, and 27 months
Description
fasting glucose assessments
Time Frame
0, 3, 9, 15, and 27 months
Secondary Outcome Measure Information:
Title
Change from baseline patient credential at 3, 9, 15, and 27 months
Description
Patient Credential for Diabetes Patients developed by American Pharmacists Association Foundation (APhAF)
Time Frame
0, 3, 9, 15, and 27 months
Title
Change from baseline depression at 3, 9, 15, and 27 months
Description
Patient Health Questionnaire 2 Question Screening (PHQ-2)
Time Frame
0, 3, 9, 15, and 27 months
Title
Change from baseline food security at 3, 9, 15, and 27 months
Description
Food Security Screening Questionnaire
Time Frame
0, 3, 9, 15, and 27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 Pregnant Receiving immunosuppressant therapy following transplant Diagnosis of serious mental illness Undergoing systemic treatment with prednisone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Sherr, MS, RD, CDE
Organizational Affiliation
American Association of Diabetes Educators
Official's Role
Principal Investigator
Facility Information:
Facility Name
El Rio Community Health Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85701
Country
United States
Facility Name
Cross Trails Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Triad Adult and Pediatric Medicine, Inc.
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
FamilyCare Health Center
City
Scott Depot
State/Province
West Virginia
ZIP/Postal Code
25560
Country
United States

12. IPD Sharing Statement

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

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