Fostering Sustainability Through Diabetes Self-Management Support

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Diabetes Self Management Support (DSMS)

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 Type: Interventional
• Enrollment (Actual): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Gretchen Piatt, MPH, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Actual): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: African-American
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: HUM00104965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO