Walk Together Efficacy Trial

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07849920
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Walk Together — BEHAVIORAL
    Walk Together incudes four sessions delivered in patients' primary care clinics (in-person or via telehealth) over approximately eight weeks. Sessions are dyadic (i.e., all sessions include the patient participant plus the patient's self-identified family support person), last approximately 4 hours total (ranging from 30-90 minutes each), and are facilitated by a trained behavioral interventionist with expertise in couples and family therapy. The goals of the intervention are to (a) improve family relationship quality (i.e., dyadic relationship quality and family support for hypertension self-management) and (b) improve hypertension knowledge, in order to improve hypertension self-management adherence and improve blood pressure control. All participants are provided a blood pressure monitor for remote monitoring. Environmental barriers to self-management adherence are also addressed consistent with standard care.
  • Hypertension education — BEHAVIORAL
    HypEd includes four points of contact including one dyadic (i.e., patient participants plus patient-identified family support persons) baseline session (30 minutes) that includes education on use of study-provided blood pressure monitors and accurate blood pressure monitoring, hypertension basics, and hypertension self-management goal-setting. All dyads will receive a copy of NHLBI's "On the Move to Better Heart Health for African Americans" educational booklet. Patients will then receive a phone call to check-in regarding progress in their hypertension management goal and reviewing the educational booklet at 1-2 weeks, 3-4 weeks, and 7-10 weeks. All participants will receive a blood pressure monitor for remote monitoring.

Study Details

The goal of this clinical trial is to learn if the Walk Together family-based intervention can improve hypertension self-management and blood pressure control in Black and African American primary care patients living with uncontrolled hypertension. The main questions it aims to answer are: * Do patients and family members who complete Walk Together take better care of their health? * Does Walk Together lower blood pressure? Researchers will compare the Walk Together intervention to a hypertension education intervention to see if Walk Together works to improve blood pressure. Participants will: * Complete four study sessions over 7 to 10 weeks * Measure their blood pressure at home * Answer questions about their family and their health 6 times over 8 months

Key Dates

First listed
Sep 30, 2026
Start date
Jan 18, 2027
Status verified
Sep 2026
Primary completion
Apr 18, 2031
Completion
Apr 18, 2031

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Walk Together
    Walk Together incudes four dyadic sessions, integrated into patients' primary care, to improve hypertension self-management adherence and blood pressure control via optimizing family relationship quality and increasing hypertension knowledge.
  • Sham Comparator: Hypertension Education (HypEd)
    Hypertension education control condition includes four points of contact providing hypertension education and follow-up regarding hypertension self-management.

Primary Outcome Measure

Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE) [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Department of Family and Community MedicineDallasTexas75390-

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