Clinical trial NCT05917093: Healthy Living for You
Official title: Culturally Tailoring the Delivery of an Evidence-Based Diabetes Self-Management Program for Black Adults to Enhance Its Reach, Adoption, Implementation, and Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes self-management
cultural tailoring
Healthy Living with Diabetes
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: UW Institute of Clinical and Translational Research
First posted: 2023-06-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll
timeFrame: up to 6 months
measure: Recruitment: Number of Miles Participants are Willing to Travel for a Workshop
timeFrame: up to 6 months
measure: Summary of Reasons for Agreeing to Participate Reported by Participant Count
timeFrame: up to 6 months
measure: Summary of Reasons for Declining to Participate Reported by Participant Count
timeFrame: up to 6 months
measure: Retention: Proportion of Participants who Completed the HLWD Workshop and Final Assessments
timeFrame: up to 6 months
measure: Retention Rate during a 6-week Session
timeFrame: Up to 6 weeks
measure: Summary of Reasons for Dropping Out by Participant Count
timeFrame: up to 6 months
Secondary outcomes:
measure: Effectiveness: Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale
timeFrame: Baseline, 6 weeks, 6 months
measure: Effectiveness: Patient's Perceived Involvement in Care Scale (PICS)
timeFrame: Baseline, 6 weeks, 6 months
measure: Effectiveness: Self-Reported Health Status
timeFrame: Baseline, 6 weeks, 6 months
measure: Facilitator Adoption: Number Agreeing to be a Facilitator divided by the Number Approached
timeFrame: up to 6 months
measure: Facilitator Evaluation Reported in binary Yes / No
timeFrame: up to 6 months
measure: Facilitator Feedback
timeFrame: up to 6 months
measure: Implementation: Weekly Session Attendance
timeFrame: up to 6 weeks
measure: Implementation: Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: up to 6 weeks
measure: Implementation: Participant Satisfaction Ratings
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: YMCA
state: Wisconsin
city: Milwaukee
country: United States
facility: Grace Fellowship Church
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michelle Chui, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: