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

NCT ID: NCT05671302

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2025-08-25

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.

Conditions

Hypertension; Family Relations

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Walk Together

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.

Group Type: EXPERIMENTAL

Walk Together

Intervention Type: 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.

Interventions

Walk Together

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sarah Woods

ASSOC PROFESSOR - Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Woods, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Family Medicine Clinic at Texas Health Dallas

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 35227154 (View on PubMed)

Other Identifiers

R21MD017658-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU-2022-0568

Identifier Type: -

Identifier Source: org_study_id