Healthy Living for You
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
- 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:
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(1) Black adults with diabetes (prior HLWD participants)
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(2) Black community leaders
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(3) current Black HLWD facilitators, and
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(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.
- 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 Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- Change in Blood Glucose [Baseline, 6 months]
Hemoglobin A1c (A1C), will be measured using A1cNow+, the National Glycohemoglobin Standardization Program Certified, CLIA-waived, system that provides results using a finger stick test.
Secondary Outcome Measures
- DOSE-Nonadherence Survey [Baseline, 6 weeks, 6 months]
The DOSE-Nonadherence measure screens for nonadherence and is calculated by computing the mean of the 3 items (range of score is 1-5). Mean scores of 3 (i.e., scoring "1" on each of the 3 items) will be classified as nonadherent, while all mean scores >3 will be classified as adherent.
- Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score [Baseline, 6 weeks, 6 months]
The ARMS-D is a 12-item survey where each item is scored from from 1="none of the time" to 4="all of the time," summed for an overall adherence score from 12-48, with higher scores representing more problems with medication adherence.
Other Outcome Measures
- Systolic Blood Pressure [Baseline, 6 weeks, 6 months]
- Diastolic Blood Pressure [Baseline, 6 weeks, 6 months]
- Self-Reported Health Status [Baseline, 6 weeks, 6 months]
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.
- Brief Illness Perception Questionnaire (B-IPQ) [Baseline, 6 weeks, 6 months]
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.
- Beliefs about Medicines Questionnaire (BMQ) [Baseline, 6 weeks, 6 months]
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.
- Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale [Baseline, 6 weeks, 6 months]
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.
- Diabetes Distress Scale (DDS-2) [Baseline, 6 weeks, 6 months]
DDS-2 is a 2-item survey scored from 1-6 where higher scores indicate more distress.
- Patient's Perceived Involvement in Care Scale (PICS) [Baseline, 6 weeks, 6 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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self-identify as Black/African American
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have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes
Exclusion Criteria:
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Wisconsin, Madison
- UW Institute of Clinical and Translational Research
Investigators
- Principal Investigator: Olayinka Shiyanbola, PhD, BPharm, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-0821
- Protocol Version 5/24/2023
- PHARM/PHARMACY