HypertensionNCT07849920
Walk Together Efficacy Trial
A study testing Walk Together and Hypertension education in people with Hypertension, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Walk Together and Hypertension education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2027to 18 Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT Southwestern Department of Family and Community Medicine
Dallas, Texas, 75390
About this study
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.
Read more
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
Read the detailed description
Hypertension is the most significant risk factor for racial disparities in mortality and life expectancy. African Americans, in particular, are at greater risk of developing hypertension earlier and experiencing worse hypertension-related outcomes. Hypertension is also a modifiable risk factor for cardiovascular disease, in part via self-management behavior which is critical for achieving hypertension control. Black and African American individuals often report difficulties with self-management adherence due in part to challenges in sustaining necessary lifestyle changes, and environmental barriers to engaging in self-care. African Americans also frequently report family emotional and behavioral support is critical for achieving self-management goals, while shared health behaviors, insufficient support, and family stress are often identified as barriers to self-management. Yet, family support has remained an untapped resource in hypertension self-management interventions. This study will test the efficacy of a new family-based hypertension self-management intervention which was designed and adapted with and for Black and African American primary care patients living with uncontrolled hypertension and their family support persons via prior community-based participatory research. The intervention -- Walk Together -- includes four dyadic (i.e., patient plus family support person) sessions over approximately eight weeks with the goal of optimizing family relationship quality including family support for hypertension self-management, plus improving hypertension knowledge, while addressing common barriers to hypertension management via referrals to standard of care resources, health information technology, and integration into patients' primary care clinics. Using a randomized controlled trial design, the investigators will (1) identify the extent to which the Walk Together intervention increases hypertension self-management adherence and improves blood pressure control compared to a hypertension education control condition (HypEd); (2) examine family support (i.e., patient-family support person relationship quality, and family support for hypertension management behaviors) and hypertension knowledge as mechanisms of effect through which Walk Together leads to improvements in self-management adherence and blood pressure control outcomes; and, (3) evaluate the family-level positive health impacts of the Walk Together intervention on participating family support persons' hypertension knowledge and health behaviors.
- Conditions
- Hypertension
- Being tested
- Walk Together, Hypertension education
- Keywords
- Family support, Integrated health care systems, Healthy lifestyle, Hypertension, Community-based participatory research, Primary care, African American, Blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk TogetherBehavioural
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 educationBehavioural
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 National Heart Lung and Blood Institute'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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Hypertension education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Measured: 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 Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Measured: 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 Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Measured: 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 Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Measured: 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 Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Measured: Baseline
Blood pressure control
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Measured: 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. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Measured: 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. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Measured: 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. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Measured: 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. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.
Measured: Baseline
Blood pressure control
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.
Measured: Month 1
Blood pressure control
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.
Measured: Month 2
Blood pressure control
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.
Measured: Month 7
Secondary outcomes (20)
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Dyadic (i.e., patient-family support person) relationship satisfaction is measured by the Relationship Satisfaction Index (adapted for this study from the Couples Satisfaction Index). Possible scores range from 0 to 21, where higher scores mean greater satisfaction.
Measured: Baseline
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Dyadic (i.e., patient-family support person) relationship satisfaction is measured by the Relationship Satisfaction Index (adapted for this study from the Couples Satisfaction Index). Possible scores range from 0 to 21, where higher scores mean greater satisfaction.
Measured: Following session 3 (approx. 3 weeks after Baseline)
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Dyadic (i.e., patient-family support person) relationship satisfaction is measured by the Relationship Satisfaction Index (adapted for this study from the Couples Satisfaction Index). Possible scores range from 0 to 21, where higher scores mean greater satisfaction.
Measured: Following session 4 (approx. 7-10 weeks after Baseline)
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Dyadic (i.e., patient-family support person) relationship satisfaction is measured by the Relationship Satisfaction Index (adapted for this study from the Couples Satisfaction Index). Possible scores range from 0 to 21, where higher scores mean greater satisfaction.
Measured: 1 month post-protocol (approximately 3 months after Baseline)
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Dyadic (i.e., patient-family support person) relationship satisfaction is measured by the Relationship Satisfaction Index (adapted for this study from the Couples Satisfaction Index). Possible scores range from 0 to 21, where higher scores mean greater satisfaction.
Measured: 6 months post-protocol (approximately 9 months after Baseline)
Family relationship quality as measured by the FACES-IV Short Form
Family relationship quality (broadly, in family relationships specified by the participant) is measured by the 24-item, 8-subscale Family Adaptability and Cohesion Scale IV - Short Form (FACES IV-SF). Possible scores range from 3-15 for each subscale where higher scores indicate higher levels of the subscale's dimension.
Measured: Baseline
Family relationship quality as measured by the FACES-IV Short Form
Family relationship quality (broadly, in family relationships specified by the participant) is measured by the 24-item, 8-subscale Family Adaptability and Cohesion Scale IV - Short Form (FACES IV-SF). Possible scores range from 3-15 for each subscale where higher scores indicate higher levels of the subscale's dimension.
Measured: Following session 3 (approx. 3 weeks after Baseline)
Family relationship quality as measured by the FACES-IV Short Form
Family relationship quality (broadly, in family relationships specified by the participant) is measured by the 24-item, 8-subscale Family Adaptability and Cohesion Scale IV - Short Form (FACES IV-SF). Possible scores range from 3-15 for each subscale where higher scores indicate higher levels of the subscale's dimension.
Measured: Following session 4 (approx. 7-10 weeks after Baseline)
Family relationship quality as measured by the FACES-IV Short Form
Family relationship quality (broadly, in family relationships specified by the participant) is measured by the 24-item, 8-subscale Family Adaptability and Cohesion Scale IV - Short Form (FACES IV-SF). Possible scores range from 3-15 for each subscale where higher scores indicate higher levels of the subscale's dimension.
Measured: 1 month post-protocol (approximately 3 months after Baseline)
Family relationship quality as measured by the FACES-IV Short Form
Family relationship quality (broadly, in family relationships specified by the participant) is measured by the 24-item, 8-subscale Family Adaptability and Cohesion Scale IV - Short Form (FACES IV-SF). Possible scores range from 3-15 for each subscale where higher scores indicate higher levels of the subscale's dimension.
Measured: 6 months post-protocol (approximately 9 months after Baseline)
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Family support for hypertension management is measured by the family and friends subscale of the Chronic Illness Resources Survey. Possible scores range from 1-5, where higher scores indicate greater support.
Measured: Baseline
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Family support for hypertension management is measured by the family and friends subscale of the Chronic Illness Resources Survey. Possible scores range from 1-5, where higher scores indicate greater support.
Measured: Following session 3 (approx. 3 weeks after Baseline)
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Family support for hypertension management is measured by the family and friends subscale of the Chronic Illness Resources Survey. Possible scores range from 1-5, where higher scores indicate greater support.
Measured: Following session 4 (approx. 7-10 weeks after Baseline)
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Family support for hypertension management is measured by the family and friends subscale of the Chronic Illness Resources Survey. Possible scores range from 1-5, where higher scores indicate greater support.
Measured: 1 month post-protocol (approximately 3 months after Baseline)
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Family support for hypertension management is measured by the family and friends subscale of the Chronic Illness Resources Survey. Possible scores range from 1-5, where higher scores indicate greater support.
Measured: 6 months post-protocol (approximately 9 months after Baseline)
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Patients' knowledge of hypertension facts will be assessed via the Hypertension Evaluation of Lifestyle and Management Knowledge Scale. Possible scores range from 0 to 13 with higher scores indicating greater knowledge.
Measured: Baseline
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Patients' knowledge of hypertension facts will be assessed via the Hypertension Evaluation of Lifestyle and Management Knowledge Scale. Possible scores range from 0 to 13 with higher scores indicating greater knowledge.
Measured: Following session 3 (approx. 3 weeks after Baseline)
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Patients' knowledge of hypertension facts will be assessed via the Hypertension Evaluation of Lifestyle and Management Knowledge Scale. Possible scores range from 0 to 13 with higher scores indicating greater knowledge.
Measured: Following session 4 (approx. 7-10 weeks after Baseline)
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Patients' knowledge of hypertension facts will be assessed via the Hypertension Evaluation of Lifestyle and Management Knowledge Scale. Possible scores range from 0 to 13 with higher scores indicating greater knowledge.
Measured: 1 month post-protocol (approximately 3 months after Baseline)
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Patients' knowledge of hypertension facts will be assessed via the Hypertension Evaluation of Lifestyle and Management Knowledge Scale. Possible scores range from 0 to 13 with higher scores indicating greater knowledge.
Measured: 6 months post-protocol (approximately 9 months after Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start18 Jan 2027 (estimated)
- Primary completion18 Apr 2031 (estimated)
- Study completion18 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Sarah Woods, University of Texas Southwestern Medical Center
- Investigators
- Sarah Woods, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849920
- Sponsor's protocol ID
- STU20261188
- Other IDs
- R01MD021505
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All direct respondent identifiers (e.g., names, EHR chart numbers) will be removed and maintained in a secure file for data linkage purposes, and will not be shared. Deidentification will be completed by the end of data processing, prior to the finalization of the public use data files. All other scientific data (survey data, EHR medical and blood pressure data) will be both preserved and shared, once deidentification is complete. A data dictionary which includes variable names, variable labels, question text as allowable, values, value labels, explanations of missing data, and scale-level descriptions and calculations, will also be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walk Together Efficacy Trial
- ClinicalTrials.gov ID
- NCT07849920
- Acronym / sponsor ID
- STU20261188
- Conditions
- Hypertension
- Keywords
- Family support, Integrated health care systems, Healthy lifestyle, Hypertension, Community-based participatory research, Primary care, African American, Blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 18 Jan 2027 (estimated)
- Primary completion
- 18 Apr 2031 (estimated)
- Study completion
- 18 Apr 2031 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Hypertension is the most significant risk factor for racial disparities in mortality and life expectancy. African Americans, in particular, are at greater risk of developing hypertension earlier and experiencing worse hypertension-related outcomes. Hypertension is also a modifiable risk factor for cardiovascular disease, in part via self-management behavior which is critical for achieving hypertension control. Black and African American individuals often report difficulties with self-management adherence due in part to challenges in sustaining necessary lifestyle changes, and environmental barriers to engaging in self-care. African Americans also frequently report family emotional and behavioral support is critical for achieving self-management goals, while shared health behaviors, insufficient support, and family stress are often identified as barriers to self-management. Yet, family support has remained an untapped resource in hypertension self-management interventions. This study will test the efficacy of a new family-based hypertension self-management intervention which was designed and adapted with and for Black and African American primary care patients living with uncontrolled hypertension and their family support persons via prior community-based participatory research. The intervention -- Walk Together -- includes four dyadic (i.e., patient plus family support person) sessions over approximately eight weeks with the goal of optimizing family relationship quality including family support for hypertension self-management, plus improving hypertension knowledge, while addressing common barriers to hypertension management via referrals to standard of care resources, health information technology, and integration into patients' primary care clinics. Using a randomized controlled trial design, the investigators will (1) identify the extent to which the Walk Together intervention increases hypertension self-management adherence and improves blood pressure control compared to a hypertension education control condition (HypEd); (2) examine family support (i.e., patient-family support person relationship quality, and family support for hypertension management behaviors) and hypertension knowledge as mechanisms of effect through which Walk Together leads to improvements in self-management adherence and blood pressure control outcomes; and, (3) evaluate the family-level positive health impacts of the Walk Together intervention on participating family support persons' hypertension knowledge and health behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walk Together | Experimental | Behavioral: Walk TogetherWalk 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. |
| Hypertension Education (HypEd) | Sham comparator | Behavioral: Hypertension educationHypertension education control condition includes four points of contact providing hypertension education and follow-up regarding hypertension self-management. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk TogetherWalk 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. | Behavioural | Walk Together |
| Hypertension educationHypEd 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 National Heart Lung and Blood Institute'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. | Behavioural | Hypertension Education (HypEd) |
Primary outcome
Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)
Time frame: Baseline
Patients' hypertension self-management adherence will be measured by the Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)
Time frame: Following session 3 (approx. 3 weeks after Baseline)
Patients' hypertension self-management adherence will be measured by the Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)
Time frame: Following session 4 (approx. 7-10 weeks after Baseline)
Patients' hypertension self-management adherence will be measured by the Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)
Time frame: 1 month post-protocol (approximately 3 months after Baseline)
Patients' hypertension self-management adherence will be measured by the Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)
Time frame: 6 months post-protocol (approximately 9 months after Baseline)
Patients' hypertension self-management adherence will be measured by the Hypertension Self-Care Activity Level Effects (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. Higher scores indicate greater adherence.
Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence
Time frame: Baseline
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
Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence
Time frame: Following session 3 (approx. 3 weeks after Baseline)
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
Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence
Time frame: Following session 4 (approx. 7-10 weeks after Baseline)
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
Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence
Time frame: 1 month post-protocol (approximately 3 months after Baseline)
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
Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence
Time frame: 6 months post-protocol (approximately 9 months after Baseline)
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
Blood pressure control
Time frame: Baseline
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Blood pressure control
Time frame: 1 month (readings completed within 7 days of session 3)
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Blood pressure control
Time frame: 2 months (readings completed within 7 days of session 4)
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Blood pressure control
Time frame: 1 month post-protocol (approximately 3 months after Baseline, using 7-day averages)
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Blood pressure control
Time frame: 6 months post-protocol (approximately 9 months after Baseline, using 7-day averages)
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed within 7 days of the primary outcome timeframe.
Blood pressure control
Time frame: Baseline
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.
Blood pressure control
Time frame: Month 1
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.
Blood pressure control
Time frame: Month 2
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.
Blood pressure control
Time frame: Month 7
Patients will be asked to complete three consecutive measurements, once daily, in the morning. All three measurements, and the last two measurements, will be averaged at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used). Blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and/or diastolic BP less than or equal to 80) will be assessed using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.
20 secondary outcomes
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Time frame: Baseline
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Time frame: Following session 3 (approx. 3 weeks after Baseline)
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Time frame: Following session 4 (approx. 7-10 weeks after Baseline)
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Time frame: 1 month post-protocol (approximately 3 months after Baseline)
Dyadic relationship satisfaction as measured by the adapted Relationship Satisfaction Index
Time frame: 6 months post-protocol (approximately 9 months after Baseline)
Family relationship quality as measured by the FACES-IV Short Form
Time frame: Baseline
Family relationship quality as measured by the FACES-IV Short Form
Time frame: Following session 3 (approx. 3 weeks after Baseline)
Family relationship quality as measured by the FACES-IV Short Form
Time frame: Following session 4 (approx. 7-10 weeks after Baseline)
Family relationship quality as measured by the FACES-IV Short Form
Time frame: 1 month post-protocol (approximately 3 months after Baseline)
Family relationship quality as measured by the FACES-IV Short Form
Time frame: 6 months post-protocol (approximately 9 months after Baseline)
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Time frame: Baseline
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Time frame: Following session 3 (approx. 3 weeks after Baseline)
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Time frame: Following session 4 (approx. 7-10 weeks after Baseline)
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Time frame: 1 month post-protocol (approximately 3 months after Baseline)
Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey
Time frame: 6 months post-protocol (approximately 9 months after Baseline)
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Time frame: Baseline
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Time frame: Following session 3 (approx. 3 weeks after Baseline)
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Time frame: Following session 4 (approx. 7-10 weeks after Baseline)
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Time frame: 1 month post-protocol (approximately 3 months after Baseline)
Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale
Time frame: 6 months post-protocol (approximately 9 months after Baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. All direct respondent identifiers (e.g., names, EHR chart numbers) will be removed and maintained in a secure file for data linkage purposes, and will not be shared. Deidentification will be completed by the end of data processing, prior to the finalization of the public use data files. All other scientific data (survey data, EHR medical and blood pressure data) will be both preserved and shared, once deidentification is complete. A data dictionary which includes variable names, variable labels, question text as allowable, values, value labels, explanations of missing data, and scale-level descriptions and calculations, will also be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Woods, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk Together and Hypertension education in people with Hypertension, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (214-645-9532, WalkTogether@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension self-management behavior adherence as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE) (time frame: Baseline). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.