Healthy Living for You
Primary Purpose
Diabetes
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Culturally tailored HLWD
Sponsored by
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
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
NCT ID
NCT05917093
First Posted
June 14, 2023
Last Updated
June 22, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
UW Institute of Clinical and Translational Research
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
Learn more about this trial
Healthy Living for You
We'll reach out to this number within 24 hrs