NCT05671302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 5, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

October 13, 2022

Last Update Submit

September 15, 2025

Conditions

HypertensionFamily Relations

Keywords

Family supportIntegrated health care systemsHealthy lifestyleCommunity-based participatory researchAfrican Americans

Outcome Measures

Primary Outcomes (6)

  • 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

    11 months

  • 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

    11 months

  • 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

    11 months

  • 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

    11 months

  • 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

    11 months

  • 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

    Protocol completion (approx. 24 months)

Secondary Outcomes (12)

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

    Baseline

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

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

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

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

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

    Baseline

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

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

  • +7 more secondary outcomes

Study Arms (1)

Walk Together

EXPERIMENTAL

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.

Behavioral: Walk Together

Interventions

Walk TogetherBEHAVIORAL

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.

Walk Together

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Family Medicine Clinic at Texas Health Dallas

Dallas, Texas, 75231, United States

Location

Related Publications (1)

  • 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.

    PMID: 35227154BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Sarah Woods, PhD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOC PROFESSOR - Family Medicine

Study Record Dates

First Submitted

October 13, 2022

First Posted

January 4, 2023

Study Start

April 5, 2024

Primary Completion

August 11, 2025

Study Completion

August 25, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)