Healthy Living for You

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Culturally tailored HLWD

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).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53205
      • YMCA
    • Milwaukee, Wisconsin, United States, 53212
      • Grace Fellowship Church

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Culturally tailored HLWD

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.; Other Names: Healthy Living With Diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll		up to 6 months
Recruitment: Number of Miles Participants are Willing to Travel for a Workshop		up to 6 months
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
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
Retention: Proportion of Participants who Completed the HLWD Workshop and Final Assessments		up to 6 months
Retention Rate during a 6-week Session		Up to 6 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Facilitator Adoption: Number Agreeing to be a Facilitator divided by the Number Approached		up to 6 months
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
Facilitator Feedback	Qualitative measure to be coded and themed, summarizing barriers to adoption.	up to 6 months
Implementation: Weekly Session Attendance		up to 6 weeks
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
Implementation: Participant Satisfaction Ratings	Participant Satisfaction Ratings are scored from 1-5, with higher scores indicating higher satisfaction.	up to 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure		Baseline, 6 weeks, 6 months
Diastolic Blood Pressure		Baseline, 6 weeks, 6 months
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
Brief Illness Perception Questionnaire (B-IPQ)	B-IPQ is an 8-item questionnaire where each item is scored from 0-10 for a total possible range of scores from 0-80. Higher scores are indicative of worse illness perception.	Baseline, 6 weeks, 6 months
Beliefs about Medicines Questionnaire (BMQ)	The BMQ is composed of 2, 5-item surveys each scored on a 5 point likert scale, one assessing the belief about Necessity of prescribed medication (total scores from 5-25), and the other assessing beliefs about Concerns of prescribed medications (total scores from 5-25). Higher scores indicate stronger beliefs.	Baseline, 6 weeks, 6 months
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
Diabetes Distress Scale (DDS-2)	DDS-2 is a 2-item survey scored from 1-6 where higher scores indicate more distress.	Baseline, 6 weeks, 6 months
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: UW Institute of Clinical and Translational Research
• Investigators: Principal Investigator: Michelle Chui, PharmD, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: diabetes self-management; cultural tailoring; Healthy Living with Diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: 2023-0821; PHARM/PHARMACY (Other Identifier: UW Madison); Protocol Version 7/9/2024 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No