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Completed

NCT Number: NCT05671302

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Family Relations Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Family Medicine Clinic at Texas Health Dallas

Dallas, Texas, 75231, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Walk Together

Behavioral

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 outcomes

  1. Feasibility of intervention as measured by the number of participants accrued

    Time frame: 11 months

    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

  2. Feasibility of intervention as measured by the rate of refusal among eligible patients/family members

    Time frame: 11 months

    Feasibility of intervention is measured by the rate of refusal among eligible patients/family members which is the number of participants refusing to consent

  3. Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components

    Time frame: 11 months

    Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components

  4. Adherence to the intervention as measured by the proportion of participants completing post-treatment assessments

    Time frame: 11 months

    Adherence to the intervention as measured by the proportion of participants completing post-treatment assessment

  5. Attrition as measured by the proportion of consented participants who dropped out of the entire study

    Time frame: 11 months

    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

  6. Acceptability of intervention as measured by 8-item Client Satisfaction Questionnaire

    Time frame: Protocol completion (approx. 24 months)

    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 outcomes

  1. Family relationship quality as measured by the FACES-IV Short Form at Baseline

    Time frame: 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.

  2. Family relationship quality as measured by the FACES-IV Short Form at following session 3

    Time frame: Following session 3 (Feedback Session, approx. 2-3 weeks after 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.

  3. Family relationship quality as measured by the FACES-IV Short Form at following session 4

    Time frame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after 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.

  4. Family relationship quality as measured by the Chronic Illness Resources Survey at Baseline

    Time frame: Baseline

    Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.

  5. Family relationship quality as measured by the Chronic Illness Resources Survey following session 3

    Time frame: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)

    Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.

  6. Family relationship quality as measured by the Chronic Illness Resources Survey following session 4

    Time frame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)

    Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.

  7. Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale at Baseline

    Time frame: 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.

  8. Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 3

    Time frame: Following session 3 (Feedback Session, approx. 2-3 weeks after 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.

  9. Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 4

    Time frame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after 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.

  10. HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline

    Time frame: 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.

  11. HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline

    Time frame: Following session 3 (Feedback Session, approx. 2-3 weeks after 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.

  12. HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline

    Time frame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 4, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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