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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 7/9/2024 | Other Identifier | UW Madison | |
| PHARM/PHARMACY | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| UW Institute of Clinical and Translational Research | UNKNOWN |
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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.
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:
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:
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culturally tailored HLWD | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally tailored HLWD | Behavioral | Participants receive the culturally tailored HLWD intervention for 6 weeks
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Chui, PharmD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| YMCA | Milwaukee | Wisconsin | 53205 | United States | ||
| Grace Fellowship Church |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 9, 2024 | Nov 19, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |
| Milwaukee |
| Wisconsin |
| 53212 |
| United States |