Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 88 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

Fostering Sustainability Through Diabetes Self-Management Support

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03021746
Recruitment Status : Recruiting
First Posted : January 16, 2017
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Gretchen Piatt, University of Michigan

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 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
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

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)



Primary Outcome Measures :
  1. A1C Blood Glucose level [ Time Frame: 33 months after baseline ]


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.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Diana Hall, MPH 734-764-3807 halldz@umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Diana Hall, MPH    734-764-3807    halldz@umich.edu   
Principal Investigator: Gretchen Piatt, MPH, PhD         
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Gretchen Piatt, MPH, PhD University of Michigan

Layout table for additonal information
Responsible Party: Gretchen Piatt, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03021746     History of Changes
Other Study ID Numbers: HUM00104965
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
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:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases