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Walk Together: A Family-Based Intervention for Hypertension In African Americans

Primary Purpose

Hypertension, Family Relations

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Walk Together
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Family support, Integrated health care systems, Healthy lifestyle, Community-based participatory research, African Americans

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Black or African American Age 18 to 75 Two blood pressure values ≥ 130/ ≥ 80 in 12 months prior Available family support person to join the intervention who agrees to participate English-speaking Exclusion Criteria: Family support person is under the age of 18 Documented cognitive impairment in patient's medical record Presence of severe psychiatric condition (i.e., current psychotic disorder or suicidality) Participation in prior hypertension health education intervention Prior participation in formative study activities (i.e., study focus groups)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Walk Together

    Arm Description

    Walk Together involves four sessions delivered in patients' primary care clinic over approximately two months. Sessions are dyadic (i.e., all sessions include the patient and a family support person), last 30-90 minutes, and are delivered by a trained family therapist. The intervention is a culturally-response, family-based intervention that is strengths-based and includes components of integrative behavioral couples therapy and motivational interviewing. The goals of the intervention are to (a) optimize family support and communication, (b) improve hypertension knowledge, (c) enhance self-management goal-setting, and (d) increase shared problem-solving to address self-management adherence barriers. Environmental barriers to adherence are also addressed consistent with standard care.

    Outcomes

    Primary Outcome Measures

    Feasibility of intervention as measured by the number of participants accrued
    Feasibility of intervention is measured by the number of participants accrued or consented and ready to participate to meet the recruitment goal of 30 dyads
    Feasibility of intervention as measured by the rate of refusal among eligible patients/family members
    Feasibility of intervention is measured by the rate of refusal among eligible patients/family members which is the number of participants refusing to consent
    Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components
    Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components
    Adherence to the intervention as measured by the proportion of participants completing post-treatment assessments
    Adherence to the intervention as measured by the proportion of participants completing post-treatment assessment
    Attrition as measured by the proportion of consented participants who dropped out of the entire study
    Attrition is defined as measured by the proportion of consented participants who dropped out of the entire study. If the dropout rate is more than 20% then it will be considered as attrition
    Acceptability of intervention as measured by 8-item Client Satisfaction Questionnaire
    Acceptability of intervention is measured by 8-item Client Satisfaction Questionnaire. Possible scores range from 8 to 32, with higher values indicating higher satisfaction

    Secondary Outcome Measures

    Family relationship quality as measured by the FACES-IV Short Form at Baseline
    Family relationship quality is measured by the Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form. Possible scores range from 1-5 where higher scores indicate better outcome.
    Family relationship quality as measured by the FACES-IV Short Form at following session 3
    Family relationship quality is measured by the Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form. Possible scores range from 1-5 where higher scores indicate better outcome.
    Family relationship quality as measured by the FACES-IV Short Form at following session 4
    Family relationship quality is measured by the Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form. Possible scores range from 1-5 where higher scores indicate better outcome.
    Family relationship quality as measured by the Chronic Illness Resources Survey at Baseline
    Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
    Family relationship quality as measured by the Chronic Illness Resources Survey following session 3
    Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
    Family relationship quality as measured by the Chronic Illness Resources Survey following session 4
    Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
    Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale at Baseline
    Health knowledge is measured by the HTN Evaluation of Lifestyle and Management Knowledge scale. Possible scores range from 0-14 where higher scores indicate better health knowledge.
    Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 3
    Health knowledge is measured by the HTN Evaluation of Lifestyle and Management Knowledge scale. Possible scores range from 0-14 where higher scores indicate better health knowledge.
    Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 4
    Health knowledge is measured by the HTN Evaluation of Lifestyle and Management Knowledge scale. Possible scores range from 0-14 where higher scores indicate better health knowledge.
    HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
    HTN self-management is measured by the HTN Self-Care Activity Level Effects measure. The Hypertension Self-Care Activity Level Effects (H-SCALE) questionnaire assesses adherence to hypertension medication (possible subscale scores range from 0-21), physical activity engagement (possible subscale scores range from 0-14), eating a healthy diet (possible subscale scores range from 0-77), alcohol intake (possible subscale scores range from 0-1), tobacco exposure (possible subscale scores range from 0-14), and weight management (possible subscale scores range from 10-50). Possible cumulative adherence (index) scores range from 0-6 where higher scores indicate better adherence.
    HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
    HTN self-management is measured by the HTN Self-Care Activity Level Effects measure. The Hypertension Self-Care Activity Level Effects (H-SCALE) questionnaire assesses adherence to hypertension medication (possible subscale scores range from 0-21), physical activity engagement (possible subscale scores range from 0-14), eating a healthy diet (possible subscale scores range from 0-77), alcohol intake (possible subscale scores range from 0-1), tobacco exposure (possible subscale scores range from 0-14), and weight management (possible subscale scores range from 10-50). Possible cumulative adherence (index) scores range from 0-6 where higher scores indicate better adherence.
    HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
    HTN self-management is measured by the HTN Self-Care Activity Level Effects measure. The Hypertension Self-Care Activity Level Effects (H-SCALE) questionnaire assesses adherence to hypertension medication (possible subscale scores range from 0-21), physical activity engagement (possible subscale scores range from 0-14), eating a healthy diet (possible subscale scores range from 0-77), alcohol intake (possible subscale scores range from 0-1), tobacco exposure (possible subscale scores range from 0-14), and weight management (possible subscale scores range from 10-50). Possible cumulative adherence (index) scores range from 0-6 where higher scores indicate better adherence.
    HTN self-management as measured by Morisky Medication Adherence Scale at Baseline
    HTN self-management is measured by Morisky Medication Adherence Scale. Possible scores range from 0-8 where higher scores indicate better adherence.
    HTN self-management as measured by Morisky Medication Adherence Scale at Baseline
    HTN self-management is measured by Morisky Medication Adherence Scale. Possible scores range from 0-8 where higher scores indicate better adherence.
    HTN self-management as measured by Morisky Medication Adherence Scale at Baseline
    HTN self-management is measured by Morisky Medication Adherence Scale. Possible scores range from 0-8 where higher scores indicate better adherence.

    Full Information

    First Posted
    October 13, 2022
    Last Updated
    January 2, 2023
    Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    National Institute on Minority Health and Health Disparities (NIMHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05671302
    Brief Title
    Walk Together: A Family-Based Intervention for Hypertension In African Americans
    Official Title
    Walk Together: A Family-Based Intervention for Hypertension In African Americans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 3, 2023 (Anticipated)
    Primary Completion Date
    May 3, 2024 (Anticipated)
    Study Completion Date
    June 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    National Institute on Minority Health and Health Disparities (NIMHD)

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this study is to determine the feasibility and acceptability of a novel family-based hypertension self-management intervention, Walk Together, adapted from an existing empirically-supported dyadic intervention, for implementation in primary care.
    Detailed Description
    Hypertension is the driving risk factor for disparities in mortality and life expectancy between African Americans and Whites. Hypertension self-management (including blood pressure monitoring, diet, exercise, and other lifestyle changes) is critical for improving hypertension control, and prior interventions have emphasized promoting patient-level behavior change to improve self-management adherence. Though family members make substantial contributions to hypertension self-management for African Americans, family support is consistently underutilized by current hypertension self-management interventions. Family-based interventions for improving self-management are effective for other chronic conditions, including for African Americans. Evidence has demonstrated the unique and important role of family support in African Americans' hypertension management, and African Americans' preferences for the direct involvement of family in hypertension interventions. The study team will develop a family-based hypertension self-management intervention ("Walk Together") for African Americans with uncontrolled hypertension that integrates community-based participatory perspectives in the specifics of the intervention. The study team will pilot trial the culturally-adapted intervention in a primary care setting in order to examine the feasibility and acceptability of the Walk Together protocol.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Family Relations
    Keywords
    Family support, Integrated health care systems, Healthy lifestyle, Community-based participatory research, African Americans

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Walk Together
    Arm Type
    Experimental
    Arm Description
    Walk Together involves four sessions delivered in patients' primary care clinic over approximately two months. Sessions are dyadic (i.e., all sessions include the patient and a family support person), last 30-90 minutes, and are delivered by a trained family therapist. The intervention is a culturally-response, family-based intervention that is strengths-based and includes components of integrative behavioral couples therapy and motivational interviewing. The goals of the intervention are to (a) optimize family support and communication, (b) improve hypertension knowledge, (c) enhance self-management goal-setting, and (d) increase shared problem-solving to address self-management adherence barriers. Environmental barriers to adherence are also addressed consistent with standard care.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Walk Together
    Intervention Description
    Receive training in the use of a study-provided blood pressure cuff and hypertension education; engage in hypertension self-management goal-setting; identify barriers to self-management adherence and utilize shared problem-solving to address barriers; connect to existing clinic resources to address environmental barriers; promote relationship strengths; practice communication and behavioral skills to address relationship concerns; engage family in support of patient self-management goals.
    Primary Outcome Measure Information:
    Title
    Feasibility of intervention as measured by the number of participants accrued
    Description
    Feasibility of intervention is measured by the number of participants accrued or consented and ready to participate to meet the recruitment goal of 30 dyads
    Time Frame
    11 months
    Title
    Feasibility of intervention as measured by the rate of refusal among eligible patients/family members
    Description
    Feasibility of intervention is measured by the rate of refusal among eligible patients/family members which is the number of participants refusing to consent
    Time Frame
    11 months
    Title
    Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components
    Description
    Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components
    Time Frame
    11 months
    Title
    Adherence to the intervention as measured by the proportion of participants completing post-treatment assessments
    Description
    Adherence to the intervention as measured by the proportion of participants completing post-treatment assessment
    Time Frame
    11 months
    Title
    Attrition as measured by the proportion of consented participants who dropped out of the entire study
    Description
    Attrition is defined as measured by the proportion of consented participants who dropped out of the entire study. If the dropout rate is more than 20% then it will be considered as attrition
    Time Frame
    11 months
    Title
    Acceptability of intervention as measured by 8-item Client Satisfaction Questionnaire
    Description
    Acceptability of intervention is measured by 8-item Client Satisfaction Questionnaire. Possible scores range from 8 to 32, with higher values indicating higher satisfaction
    Time Frame
    Protocol completion (approx. 24 months)
    Secondary Outcome Measure Information:
    Title
    Family relationship quality as measured by the FACES-IV Short Form at Baseline
    Description
    Family relationship quality is measured by the Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form. Possible scores range from 1-5 where higher scores indicate better outcome.
    Time Frame
    Baseline
    Title
    Family relationship quality as measured by the FACES-IV Short Form at following session 3
    Description
    Family relationship quality is measured by the Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form. Possible scores range from 1-5 where higher scores indicate better outcome.
    Time Frame
    Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
    Title
    Family relationship quality as measured by the FACES-IV Short Form at following session 4
    Description
    Family relationship quality is measured by the Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form. Possible scores range from 1-5 where higher scores indicate better outcome.
    Time Frame
    Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
    Title
    Family relationship quality as measured by the Chronic Illness Resources Survey at Baseline
    Description
    Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
    Time Frame
    Baseline
    Title
    Family relationship quality as measured by the Chronic Illness Resources Survey following session 3
    Description
    Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
    Time Frame
    Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
    Title
    Family relationship quality as measured by the Chronic Illness Resources Survey following session 4
    Description
    Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
    Time Frame
    Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
    Title
    Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale at Baseline
    Description
    Health knowledge is measured by the HTN Evaluation of Lifestyle and Management Knowledge scale. Possible scores range from 0-14 where higher scores indicate better health knowledge.
    Time Frame
    Baseline
    Title
    Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 3
    Description
    Health knowledge is measured by the HTN Evaluation of Lifestyle and Management Knowledge scale. Possible scores range from 0-14 where higher scores indicate better health knowledge.
    Time Frame
    Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
    Title
    Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 4
    Description
    Health knowledge is measured by the HTN Evaluation of Lifestyle and Management Knowledge scale. Possible scores range from 0-14 where higher scores indicate better health knowledge.
    Time Frame
    Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
    Title
    HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
    Description
    HTN self-management is measured by the HTN Self-Care Activity Level Effects measure. The Hypertension Self-Care Activity Level Effects (H-SCALE) questionnaire assesses adherence to hypertension medication (possible subscale scores range from 0-21), physical activity engagement (possible subscale scores range from 0-14), eating a healthy diet (possible subscale scores range from 0-77), alcohol intake (possible subscale scores range from 0-1), tobacco exposure (possible subscale scores range from 0-14), and weight management (possible subscale scores range from 10-50). Possible cumulative adherence (index) scores range from 0-6 where higher scores indicate better adherence.
    Time Frame
    Baseline
    Title
    HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
    Description
    HTN self-management is measured by the HTN Self-Care Activity Level Effects measure. The Hypertension Self-Care Activity Level Effects (H-SCALE) questionnaire assesses adherence to hypertension medication (possible subscale scores range from 0-21), physical activity engagement (possible subscale scores range from 0-14), eating a healthy diet (possible subscale scores range from 0-77), alcohol intake (possible subscale scores range from 0-1), tobacco exposure (possible subscale scores range from 0-14), and weight management (possible subscale scores range from 10-50). Possible cumulative adherence (index) scores range from 0-6 where higher scores indicate better adherence.
    Time Frame
    Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
    Title
    HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
    Description
    HTN self-management is measured by the HTN Self-Care Activity Level Effects measure. The Hypertension Self-Care Activity Level Effects (H-SCALE) questionnaire assesses adherence to hypertension medication (possible subscale scores range from 0-21), physical activity engagement (possible subscale scores range from 0-14), eating a healthy diet (possible subscale scores range from 0-77), alcohol intake (possible subscale scores range from 0-1), tobacco exposure (possible subscale scores range from 0-14), and weight management (possible subscale scores range from 10-50). Possible cumulative adherence (index) scores range from 0-6 where higher scores indicate better adherence.
    Time Frame
    Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
    Title
    HTN self-management as measured by Morisky Medication Adherence Scale at Baseline
    Description
    HTN self-management is measured by Morisky Medication Adherence Scale. Possible scores range from 0-8 where higher scores indicate better adherence.
    Time Frame
    Baseline
    Title
    HTN self-management as measured by Morisky Medication Adherence Scale at Baseline
    Description
    HTN self-management is measured by Morisky Medication Adherence Scale. Possible scores range from 0-8 where higher scores indicate better adherence.
    Time Frame
    Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
    Title
    HTN self-management as measured by Morisky Medication Adherence Scale at Baseline
    Description
    HTN self-management is measured by Morisky Medication Adherence Scale. Possible scores range from 0-8 where higher scores indicate better adherence.
    Time Frame
    Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Black or African American Age 18 to 75 Two blood pressure values ≥ 130/ ≥ 80 in 12 months prior Available family support person to join the intervention who agrees to participate English-speaking Exclusion Criteria: Family support person is under the age of 18 Documented cognitive impairment in patient's medical record Presence of severe psychiatric condition (i.e., current psychotic disorder or suicidality) Participation in prior hypertension health education intervention Prior participation in formative study activities (i.e., study focus groups)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarah B Woods, PhD
    Phone
    214-648-6225
    Email
    Sarah.Woods@UTsouthwestern.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sarah Woods, PhD
    Organizational Affiliation
    UT Southwestern Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35227154
    Citation
    Woods SB, Hiefner AR, Udezi V, Slaughter G, Moore R, Arnold EM. 'They should walk with you': the perspectives of African Americans living with hypertension and their family members on disease self-management. Ethn Health. 2023 Apr;28(3):373-398. doi: 10.1080/13557858.2022.2040958. Epub 2022 Feb 28.
    Results Reference
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    Walk Together: A Family-Based Intervention for Hypertension In African Americans

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