Walk Together Efficacy Trial

NCT07849920 | Not Yet Recruiting

• 2 other identifiers: STU20261188R01MD021505
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

Family support; Integrated health care systems; Healthy lifestyle; Hypertension; Community-based participatory research; Primary care; African American; Blood pressure

Outcome Measures

Primary Outcomes (19)

• Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)

  Patients' hypertension self-management adherence will be measured by the H-SCALE, a self-report scale with that assesses adherence to hypertension medications, physical activity, healthy (DASH) diet, alcohol intake, tobacco exposure, and weight management recommendations across 6 subscales using (a) continuous subscale scores, (b) validated dichotomized cutoffs to indicate adherence within each subscale, and (c) an overall adherence index measuring cumulative adherence, ranging from 0 to 6.

  Baseline

• Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)

  Patients' hypertension self-management adherence will be measured by the H-SCALE, a self-report scale with that assesses adherence to hypertension medications, physical activity, healthy (DASH) diet, alcohol intake, tobacco exposure, and weight management recommendations across 6 subscales using (a) continuous subscale scores, (b) validated dichotomized cutoffs to indicate adherence within each subscale, and (c) an overall adherence index measuring cumulative adherence, ranging from 0 to 6.

  Following session 3 (approx. 3 weeks after Baseline)

• Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)

  Patients' hypertension self-management adherence will be measured by the H-SCALE, a self-report scale with that assesses adherence to hypertension medications, physical activity, healthy (DASH) diet, alcohol intake, tobacco exposure, and weight management recommendations across 6 subscales using (a) continuous subscale scores, (b) validated dichotomized cutoffs to indicate adherence within each subscale, and (c) an overall adherence index measuring cumulative adherence, ranging from 0 to 6.

  Following session 4 (approx. 7-10 weeks after Baseline)

• Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)

  Patients' hypertension self-management adherence will be measured by the H-SCALE, a self-report scale with that assesses adherence to hypertension medications, physical activity, healthy (DASH) diet, alcohol intake, tobacco exposure, and weight management recommendations across 6 subscales using (a) continuous subscale scores, (b) validated dichotomized cutoffs to indicate adherence within each subscale, and (c) an overall adherence index measuring cumulative adherence, ranging from 0 to 6.

  1 month post-protocol (approximately 3 months after Baseline)

• Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)

  Patients' hypertension self-management adherence will be measured by the H-SCALE, a self-report scale with that assesses adherence to hypertension medications, physical activity, healthy (DASH) diet, alcohol intake, tobacco exposure, and weight management recommendations across 6 subscales using (a) continuous subscale scores, (b) validated dichotomized cutoffs to indicate adherence within each subscale, and (c) an overall adherence index measuring cumulative adherence, ranging from 0 to 6.

  6 months post-protocol (approximately 9 months after Baseline)

• Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence

  Hypertension self-management adherence will be, in part, assessed via adherence to blood pressure monitor (BPM) use calculated as (a) the ratio of days patient participants use their study-provided BPM to days enrolled in the study and (b) dichotomizing BPM use at greater than or equal to 70% versus less than 70% of enrolled days

  Baseline

• Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence

  Hypertension self-management adherence will be, in part, assessed via adherence to blood pressure monitor (BPM) use calculated as (a) the ratio of days patient participants use their study-provided BPM to days enrolled in the study and (b) dichotomizing BPM use at greater than or equal to 70% versus less than 70% of enrolled days

  Following session 3 (approx. 3 weeks after Baseline)

• Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence

  Hypertension self-management adherence will be, in part, assessed via adherence to blood pressure monitor (BPM) use calculated as (a) the ratio of days patient participants use their study-provided BPM to days enrolled in the study and (b) dichotomizing BPM use at greater than or equal to 70% versus less than 70% of enrolled days

  Following session 4 (approx. 7-10 weeks after Baseline)

• Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence

  Hypertension self-management adherence will be, in part, assessed via adherence to blood pressure monitor (BPM) use calculated as (a) the ratio of days patient participants use their study-provided BPM to days enrolled in the study and (b) dichotomizing BPM use at greater than or equal to 70% versus less than 70% of enrolled days

  1 month post-protocol (approximately 3 months after Baseline)

• Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence

  Hypertension self-management adherence will be, in part, assessed via adherence to blood pressure monitor (BPM) use calculated as (a) the ratio of days patient participants use their study-provided BPM to days enrolled in the study and (b) dichotomizing BPM use at greater than or equal to 70% versus less than 70% of enrolled days

  6 months post-protocol (approximately 9 months after Baseline)

• Blood pressure control

  Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) using an average of readings completed within 7 days of the primary outcome timeframe.

  Baseline

• Blood pressure control

  Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) using an average of readings completed within 7 days of the primary outcome timeframe.

  1 month (readings completed within 7 days of session 3)

• Blood pressure control

  Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) using an average of readings completed within 7 days of the primary outcome timeframe.

  2 months (readings completed within 7 days of session 4)

• Blood pressure control

  Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) using an average of readings completed within 7 days of the primary outcome timeframe.

  1 month post-protocol (approximately 3 months after Baseline, using 7-day averages)

• Blood pressure control

  Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) using an average of readings completed within 7 days of the primary outcome timeframe.

  6 months post-protocol (approximately 9 months after Baseline, using 7-day averages)

• Blood pressure control

  Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.

  Baseline

• Blood pressure control

  Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.

  Month 1

• Blood pressure control

  Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.

  Month 2

• Blood pressure control

  Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.

  Month 7

Secondary Outcomes (20)

• Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index

  Baseline

• Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index

  Following session 3 (approx. 3 weeks after Baseline)

• Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index

  Following session 4 (approx. 7-10 weeks after Baseline)

• Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index

  1 month post-protocol (approximately 3 months after Baseline)

• Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index

  6 months post-protocol (approximately 9 months after Baseline)

Other Outcomes (35)

• Hypertension knowledge as measured by the Hypertension Evaluation of Lifestyle and Management Knowledge Scale

  Baseline

• Hypertension knowledge as measured by the Hypertension Evaluation of Lifestyle and Management Knowledge Scale

  Following session 3 (approx. 3 weeks after Baseline)

• Hypertension knowledge as measured by the Hypertension Evaluation of Lifestyle and Management Knowledge Scale

  Following session 4 (approx. 7-10 weeks after Baseline)

Study Arms (2)

Walk Together

EXPERIMENTAL

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.

Behavioral: Walk Together

Hypertension Education (HypEd)

SHAM COMPARATOR

Hypertension education control condition includes four points of contact providing hypertension education and follow-up regarding hypertension self-management.

Behavioral: Hypertension education

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.

Walk Together

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.

Hypertension Education (HypEd)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Black or African American
• Age 18 to 75
• Diagnosis of essential hypertension
• Two clinic-based blood pressure values ≥ 130/ ≥ 80 in 12 months prior
• Available family support person to join the study who agrees to participate
• English-speaking

You may not qualify if:

• Diagnosis of hypertension is made exclusively during pregnancy
• Documented cognitive impairment in patient's medical record
• Presence of severe psychiatric condition (i.e., current psychotic disorder or suicidality)
• Diagnosis of sustained atrial fibrillation
• Past-year myocardial infarction
• Diagnosis of chronic kidney disease (eGFR \<20)
• Malignancy (other than non-melanoma skin cancer) in past 2 years
• Prior organ transplant
• Prior participation in earlier Walk Together studies
• Participation in prior hypertension health education intervention
• Family support person is under the age of 18 or over age of 25

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

UT Southwestern Department of Family and Community Medicine

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sarah Woods, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

214-645-9532; WalkTogether@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): January 18, 2027
• Primary Completion (Estimated): April 18, 2031
• Study Completion (Estimated): April 18, 2031
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Datasets will be made available as soon as possible following study-associated publications documenting the study's outcomes. Datasets in the repository will be maintained for at least ten years.
• Access Criteria: Data and metadata will be shared through an open access repository (the online UT Southwestern Research Data Repository, part of the Texas Data Repository Dataverse). Data users will agree not to share or redistribute any data downloads. Data downloads (usage) will be tracked by the Repository. A Creative Commons copyright (CC0) is the default license used by the Texas Data Repository, which will support discoverability and use of the collection. The Repository also requires a Data Usage Agreement for downloaders, which creates an agreement between the downloader and owner of the data governing use of the data and related materials to be downloaded.

Locations

US (1)