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Clinical Trials/NCT05917093
NCT05917093
Completed
Not Applicable

Culturally Tailoring the Delivery of an Evidence-Based Diabetes Self-Management Program for Black Adults to Enhance Its Reach, Adoption, Implementation, and Effectiveness

University of Wisconsin, Madison2 sites in 1 country32 target enrollmentApril 9, 2024
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
University of Wisconsin, Madison
Enrollment
32
Locations
2
Primary Endpoint
Recruitment: Number of Miles Participants are Willing to Travel for a Workshop
Status
Completed
Last Updated
last year

Overview

Brief Summary

The goal of the study is to conduct the Healthy Living with Diabetes (HLWD) program among Black individuals in a culturally appropriate manner. This study will involve 24-30 participants in total. Participants can expect to be on study for approximately 6 months.

Detailed Description

The study objectives are to recruit and empower Black Healthy Living with Diabetes (HLWD) facilitators to deliver culturally tailored HLWD content and pilot the culturally tailored HLWD program, using the RE-AIM framework and Proctor implementation outcomes to gather preliminary implementation data. The study team will partner with stakeholders and community organizations serving Black adults, including Grace Fellowship Church and YMCA of Metropolitan Milwaukee. The central hypothesis is that the cultural tailoring of HLWD will increase the reach, adoption, implementation, and effectiveness of HLWD among Black adults. The study aims are: 1. Co-design a culturally relevant approach to the recruitment and training of Black HLWD facilitators. The study team will partner with a stakeholder advisory board including: * (1) Black adults with diabetes (prior HLWD participants) * (2) Black community leaders * (3) current Black HLWD facilitators, and * (4) current HLWD program providers (organizational leaders in settings delivering HLWD to Black adults) to co-design: (a) an asset-based approach to recruiting Black facilitators and (b) an adjunct training that empowers the facilitator to use a culturally relevant approach to deliver HLWD content to Black adults. 2. Implement the culturally tailored HLWD program among Black adults. Using a mixed methods design, the investigators will assess recruitment/retention rates among Black adults (reach), feasibility of adoption among facilitators and program providers (adoption), participant adherence, fidelity of enactment and acceptability, fidelity of program delivery by facilitators (implementation), and pre-post impact on diabetes outcomes (effectiveness).

Registry
clinicaltrials.gov
Start Date
April 9, 2024
End Date
October 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • self-identify as Black/African American
  • have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Recruitment: Number of Miles Participants are Willing to Travel for a Workshop

Time Frame: up to 6 months

Retention: Proportion of Participants who Completed the HLWD Workshop and Final Assessments

Time Frame: up to 6 months

Summary of Reasons for Declining to Participate Reported by Participant Count

Time Frame: up to 6 months

Qualitative measure where reasons will be coded and grouped into themes for reporting.

Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll

Time Frame: up to 6 months

Summary of Reasons for Agreeing to Participate Reported by Participant Count

Time Frame: up to 6 months

Qualitative measure where reasons will be coded and grouped into themes for reporting.

Retention Rate during a 6-week Session

Time Frame: Up to 6 weeks

Summary of Reasons for Dropping Out by Participant Count

Time Frame: up to 6 months

Qualitative measure where reasons will be coded and grouped into themes for reporting.

Secondary Outcomes

  • Effectiveness: Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale(Baseline, 6 weeks, 6 months)
  • Implementation: Participant Satisfaction Ratings(up to 6 weeks)
  • Facilitator Evaluation Reported in binary Yes / No(up to 6 months)
  • Implementation: Summary of Diabetes Self-Care Activities (SDSCA)(up to 6 weeks)
  • Effectiveness: Self-Reported Health Status(Baseline, 6 weeks, 6 months)
  • Facilitator Adoption: Number Agreeing to be a Facilitator divided by the Number Approached(up to 6 months)
  • Effectiveness: Patient's Perceived Involvement in Care Scale (PICS)(Baseline, 6 weeks, 6 months)
  • Facilitator Feedback(up to 6 months)
  • Implementation: Weekly Session Attendance(up to 6 weeks)

Study Sites (2)

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