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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by American Association of Diabetes Educators
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
American Association of Diabetes Educators
ClinicalTrials.gov Identifier:
NCT02160639
First received: June 6, 2014
Last updated: June 11, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluating the Impact of Year Long, Augmented Diabetes Self Management Support

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    HbA1c assessment

  • Change from baseline blood pressure at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ] [ Designated as safety issue: No ]
    blood pressure assessments

  • Change from baseline cholesterol at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ] [ Designated as safety issue: No ]
    cholesterol assessments

  • Change from baseline BMI at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    weight assessments

  • Change from baseline fasting glucose at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ] [ Designated as safety issue: No ]
    fasting glucose assessments


Secondary Outcome Measures:
  • Change from baseline diabetes knowledge at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ] [ Designated as safety issue: No ]
    23-item Diabetes Knowledge Test (DKT) developed by Michigan Diabetes Research and Training Center

  • Change from baseline diabetes self-care behavior at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ] [ Designated as safety issue: No ]
    diabetes self-care engagement assessment

  • Change from baseline diabetes-specific quality of life at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ] [ Designated as safety issue: No ]
    Problem Areas in Diabetes (PAID) Questionnaire

  • Change from baseline health-related quality of life at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ] [ Designated as safety issue: No ]
    Short Form-12 Health Survey

  • Change from baseline depression at 3, 9, 15, and 27 months [ Time Frame: 0, 3, 9, 15, and 27 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Food Security Screening Questionnaire


Estimated Enrollment: 512
Study Start Date: September 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02160639

Contacts
Contact: Ruth Lipman, PhD 312-601-4854 rlipman@aadenet.org

Locations
United States, Arizona
El Rio Community Health Center Not yet recruiting
Tucson, Arizona, United States, 85701
Contact: Sandra Leal    520-302-5325    SLealPharmD@gmail.com   
Principal Investigator: Sandra Leal         
United States, Illinois
Mercy Hospital and Medical Center Not yet recruiting
Chicago, Illinois, United States, 60616
Contact: Beryl Larson    312-567-8775    blarson@mercy-chicago.org   
Principal Investigator: Beryl Larson         
United States, North Carolina
Triad Adult and Pediatric Medicine, Inc. Not yet recruiting
High Point, North Carolina, United States, 27262
Contact: Megan Kraskouskas    703-216-4975    MKraskouskas@tapmedicine.com   
Principal Investigator: Megan Kraskouskas         
United States, Wisconsin
Marshfield Clinic Not yet recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Marilyn Hodgson    715-387-9412    hodgson.marilyn@marshfieldclinic.org   
Principal Investigator: Marilyn Hodgson         
Sponsors and Collaborators
American Association of Diabetes Educators
Bristol-Myers Squibb
Investigators
Principal Investigator: Ruth Lipman, PhD American Association of Diabetes Educators
  More Information

No publications provided

Responsible Party: American Association of Diabetes Educators
ClinicalTrials.gov Identifier: NCT02160639     History of Changes
Other Study ID Numbers: BMS-DSMES-2014
Study First Received: June 6, 2014
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 31, 2014