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Healthy Living for You

Primary Purpose

Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Culturally tailored HLWD
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes focused on measuring diabetes self-management, cultural tailoring, Healthy Living with Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: self-identify as Black/African American have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes Exclusion Criteria: -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Culturally tailored HLWD

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Blood Glucose
    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
    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
    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.

    Full Information

    First Posted
    June 14, 2023
    Last Updated
    June 22, 2023
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    UW Institute of Clinical and Translational Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05917093
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2024 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    UW Institute of Clinical and Translational Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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: (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. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes
    Keywords
    diabetes self-management, cultural tailoring, Healthy Living with Diabetes

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Culturally tailored HLWD
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Culturally tailored HLWD
    Other Intervention Name(s)
    Healthy Living With Diabetes
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Blood Glucose
    Description
    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.
    Time Frame
    Baseline, 6 months
    Secondary Outcome Measure Information:
    Title
    DOSE-Nonadherence Survey
    Description
    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.
    Time Frame
    Baseline, 6 weeks, 6 months
    Title
    Adherence to Refills and Medicines Scale for Diabetes (ARMS-D) Score
    Description
    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.
    Time Frame
    Baseline, 6 weeks, 6 months
    Other Pre-specified Outcome Measures:
    Title
    Systolic Blood Pressure
    Time Frame
    Baseline, 6 weeks, 6 months
    Title
    Diastolic Blood Pressure
    Time Frame
    Baseline, 6 weeks, 6 months
    Title
    Self-Reported Health Status
    Description
    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.
    Time Frame
    Baseline, 6 weeks, 6 months
    Title
    Brief Illness Perception Questionnaire (B-IPQ)
    Description
    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.
    Time Frame
    Baseline, 6 weeks, 6 months
    Title
    Beliefs about Medicines Questionnaire (BMQ)
    Description
    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.
    Time Frame
    Baseline, 6 weeks, 6 months
    Title
    Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale
    Description
    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.
    Time Frame
    Baseline, 6 weeks, 6 months
    Title
    Diabetes Distress Scale (DDS-2)
    Description
    DDS-2 is a 2-item survey scored from 1-6 where higher scores indicate more distress.
    Time Frame
    Baseline, 6 weeks, 6 months
    Title
    Patient's Perceived Involvement in Care Scale (PICS)
    Description
    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.
    Time Frame
    Baseline, 6 weeks, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: self-identify as Black/African American have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes Exclusion Criteria: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Martha Maurer, MSSW, MPH, PhD
    Phone
    608-265-2662
    Email
    mamaurer@wisc.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olayinka Shiyanbola, PhD, BPharm
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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