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Fostering Sustainability Through Diabetes Self-Management Support

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ClinicalTrials.gov Identifier: NCT03021746
Recruitment Status : Completed
First Posted : January 16, 2017
Last Update Posted : December 16, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Gretchen Piatt, University of Michigan

Study Description
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Brief Summary:
To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Diabetes Self Management Support (DSMS) Not Applicable

Detailed Description:
To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Fostering Sustainability Through Diabetes Self-Management Support
Study Start Date : March 2016
Actual Primary Completion Date : August 31, 2021
Actual Study Completion Date : August 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Parish Nurse plus Peer Leader
The focus of this approach is for Peer Leaders (PL) to provide Diabetes Self Management Support (DSMS) with the oversight of Parish Nurses (PN). The first component starts with group-based Diabetes Self Management Education (DSME) provided by Certified Diabetes Educators (CDE), co-facilitated by PN and PL and held at the church. PL will also facilitate activities including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit, with oversight of PN. As the study progresses, PL and PN will have progressive leadership responsibilities. Following DSME, participants will be invited to attend 12 months of monthly DSMS support groups led by the PL, with oversight from the PN. This approach allows for PN to provide direct supervision to PL in areas of clinical content, educational methods, and group facilitation and communication skills.
 Behavioral: Diabetes Self Management Support (DSMS)
Experimental: Peer Leader Only
This approach will contain the same elements as the PN plus PL approach, except that a PN will not be used. Rather, PL will provide all aspects of DSMS, including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. This approach will be delivered in a group setting. DSME will be provided by CDEs and co-facilitated by a PL to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 monthly DSMS groups led by PL. Following the group sessions, participants will transition into a period of ongoing support. During this time, participants and PL will be encouraged to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. If needed, PL may contact the CDE for additional information
 Behavioral: Diabetes Self Management Support (DSMS)
Experimental: Parish Nurse Only
The main focus of this approach will contain all of the same elements as the PN plus PL approach, except that PL will not be used. Rather, the PN will provide all aspects of Diabetes Self Management Support (DSMS), including facilitation of goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. Diabetes Self Management Education (DSME) will be provided by CDEs and co-facilitated by a PN to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 months of monthly, DSMS support groups led by the PN. Following support sessions, participants will transition into a period of ongoing support, where the participants and PN will be encouraged to continue to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. The PN may answer clinical questions and may contact the CDE for additional information if needed.
 Behavioral: Diabetes Self Management Support (DSMS)


Outcome Measures
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Primary Outcome Measures :
  1. Change in A1C Blood Glucose level [ Time Frame: During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months. ]
    An A1C test is a blood test that reflects one's average blood glucose levels over the previous 3 months.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have Type 2 diabetes for at least 6 months
  • Be Black/African American
  • Be a resident of metro-Detroit, Toledo, or Flint
  • Be at least 21 years old
  • Be under the care of a physician for diabetes
  • Have transportation to attend the program

Exclusion Criteria:

  • Have Type 2 diabetes for less than 6 months
  • Under 21 years of age
  • Not under care of physician
  • Lack of transportation to attend the program
Contacts and Locations
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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): NCT03021746


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Gretchen Piatt, MPH, PhD University of Michigan
More Information
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Responsible Party: Gretchen Piatt, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03021746    
Other Study ID Numbers: HUM00104965
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gretchen Piatt, University of Michigan:
African-American
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases