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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02160639
First Posted: June 11, 2014
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
American Association of Diabetes Educators
  Purpose
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.

Condition Intervention
Diabetes Mellitus Type 2 Other: diabetes self management support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support

Further study details as provided by American Association of Diabetes Educators:

Primary Outcome Measures:
  • Change from baseline HbA1c at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ]
    HbA1c assessment

  • Change from baseline blood pressure at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ]
    blood pressure assessments

  • Change from baseline cholesterol at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ]
    cholesterol assessments

  • Change from baseline BMI at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ]
    body mass index (BMI) assessments

  • Change from baseline weight at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ]
    weight assessments

  • Change from baseline fasting glucose at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ]
    fasting glucose assessments


Secondary Outcome Measures:
  • Change from baseline patient credential at 3, 9, 15, and 27 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 0, 3, 9, 15, and 27 months ]
    Food Security Screening Questionnaire


Enrollment: 449
Study Start Date: January 2015
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160639


Locations
United States, Arizona
El Rio Community Health Center
Tucson, Arizona, United States, 85701
United States, Missouri
Cross Trails Medical Center
Cape Girardeau, Missouri, United States, 63703
United States, North Carolina
Triad Adult and Pediatric Medicine, Inc.
High Point, North Carolina, United States, 27262
United States, West Virginia
FamilyCare Health Center
Scott Depot, West Virginia, United States, 25560
Sponsors and Collaborators
American Association of Diabetes Educators
Bristol-Myers Squibb
Investigators
Principal Investigator: Dawn Sherr, MS, RD, CDE American Association of Diabetes Educators
  More Information

Responsible Party: American Association of Diabetes Educators
ClinicalTrials.gov Identifier: NCT02160639     History of Changes
Other Study ID Numbers: BMS-DSMES-2014
First Submitted: June 6, 2014
First Posted: June 11, 2014
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by American Association of Diabetes Educators:
diabetes self management education
diabetes self management support
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases


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