Healthy Living for You

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917093
• Other study ID #: 2023-0821
• Secondary ID: Protocol Version
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: Martha Maurer, MSSW, MPH, PhD
• Phone: 608-265-2662
• Email: mamaurer[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• self-identify as Black/African American

• have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Behavioral:
• Culturally tailored HLWD
Participants receive the culturally tailored HLWD intervention for 6 weeks Week 0 - Baseline enrollment. Weeks 1-6 will consist of 6 separate group sessions. Diabetes self-management topics will be covered by 2 Black HLWD Facilitators. Participants will meet once a week, for a 2½-hour session, in community settings such as a community center, or church.

Locations

Country	Name	City	State
United States	Grace Fellowship Church	Milwaukee	Wisconsin
United States	YMCA	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	UW Institute of Clinical and Translational Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll		up to 6 months
Primary	Recruitment: Number of Miles Participants are Willing to Travel for a Workshop		up to 6 months
Primary	Summary of Reasons for Agreeing to Participate Reported by Participant Count	Qualitative measure where reasons will be coded and grouped into themes for reporting.	up to 6 months
Primary	Summary of Reasons for Declining to Participate Reported by Participant Count	Qualitative measure where reasons will be coded and grouped into themes for reporting.	up to 6 months
Primary	Retention: Proportion of Participants who Completed the HLWD Workshop and Final Assessments		up to 6 months
Primary	Retention Rate during a 6-week Session		Up to 6 weeks
Primary	Summary of Reasons for Dropping Out by Participant Count	Qualitative measure where reasons will be coded and grouped into themes for reporting.	up to 6 months
Secondary	Effectiveness: Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale	The Diabetes Empowerment Scale is a 8-item survey each scored on a 5 point likert scale. This scale assesses the patients' perceived ability to obtain social support, manage stress, be self-motivating and make diabetes-related decisions. A total range of score is from 0-40. Higher score indicate higher diabetes empowerment.	Baseline, 6 weeks, 6 months
Secondary	Effectiveness: Patient's Perceived Involvement in Care Scale (PICS)	PICS is a 13-item survey where each item is scored yes (1) or no (0) for a total range of scores from 0-13. This instrument is designed to examine three relatively distinct factors: (1) doctor facilitation of patient involvement, (2) level of information exchange, and (3) patient participation in decision making. Higher score indicate higher patient/provider communication quality.	Baseline, 6 weeks, 6 months
Secondary	Effectiveness: Self-Reported Health Status	Participants self-reported their overall health on a scale of by selecting one of the 5 options: poor, fair, good , very good, or excellent. Scoring is from 1-5 with higher scores indicating poor health.	Baseline, 6 weeks, 6 months
Secondary	Facilitator Adoption: Number Agreeing to be a Facilitator divided by the Number Approached		up to 6 months
Secondary	Facilitator Evaluation Reported in binary Yes / No	Facilitators will be asked if they satisfied with the training and experience of being a facilitator? Would they consider leading another program? Would they recommend being a facilitator?	up to 6 months
Secondary	Facilitator Feedback	Qualitative measure to be coded and themed, summarizing barriers to adoption.	up to 6 months
Secondary	Implementation: Weekly Session Attendance		up to 6 weeks
Secondary	Implementation: Summary of Diabetes Self-Care Activities (SDSCA)	The SDSCA is a 7-item survey with each item scored from 0-7. The total possible range of scores is from 0-112, with higher scores indicating better self-care.	up to 6 weeks
Secondary	Implementation: Participant Satisfaction Ratings	Participant Satisfaction Ratings are scored from 1-5, with higher scores indicating higher satisfaction.	up to 6 weeks