HypertensionNCT05671302
Walk Together: A Family-Based Intervention for Hypertension In African Americans
A study testing Walk Together in people with Hypertension and Family Relations, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Family Relations
- What is being tested?
- Walk Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2024to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Two blood pressure values ≥ 130/ ≥ 80 in 12 months prior
- Available family support person to join the intervention who agrees to participate
- English-speaking
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Family Medicine Clinic at Texas Health Dallas
Dallas, Texas, 75231
About this study
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.
Read the 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
- Being tested
- Walk Together
- Keywords
- Family support, Integrated health care systems, Healthy lifestyle, Community-based participatory research, African Americans
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Walk Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Protocol completion (approx. 24 months)
Secondary outcomes (12)
Family relationship quality as measured by the FACES-IV Short Form at Baseline
Family relationship quality is measured by the Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form. Possible scores range from 1-5 where higher scores indicate better outcome.
Measured: Baseline
Family relationship quality as measured by the FACES-IV Short Form at following session 3
Family relationship quality is measured by the Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form. Possible scores range from 1-5 where higher scores indicate better outcome.
Measured: 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
Family relationship quality is measured by the Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form. Possible scores range from 1-5 where higher scores indicate better outcome.
Measured: 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
Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
Measured: Baseline
Family relationship quality as measured by the Chronic Illness Resources Survey following session 3
Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
Measured: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
Family relationship quality as measured by the Chronic Illness Resources Survey following session 4
Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
Measured: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale at Baseline
Health knowledge is measured by the HTN Evaluation of Lifestyle and Management Knowledge scale. Possible scores range from 0-14 where higher scores indicate better health knowledge.
Measured: Baseline
Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 3
Health knowledge is measured by the HTN Evaluation of Lifestyle and Management Knowledge scale. Possible scores range from 0-14 where higher scores indicate better health knowledge.
Measured: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 4
Health knowledge is measured by the HTN Evaluation of Lifestyle and Management Knowledge scale. Possible scores range from 0-14 where higher scores indicate better health knowledge.
Measured: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
HTN self-management is measured by the HTN Self-Care Activity Level Effects measure. The Hypertension Self-Care Activity Level Effects (H-SCALE) questionnaire assesses adherence to hypertension medication (possible subscale scores range from 0-21), physical activity engagement (possible subscale scores range from 0-14), eating a healthy diet (possible subscale scores range from 0-77), alcohol intake (possible subscale scores range from 0-1), tobacco exposure (possible subscale scores range from 0-14), and weight management (possible subscale scores range from 10-50). Possible cumulative adherence (index) scores range from 0-6 where higher scores indicate better adherence.
Measured: Baseline
HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
HTN self-management is measured by the HTN Self-Care Activity Level Effects measure. The Hypertension Self-Care Activity Level Effects (H-SCALE) questionnaire assesses adherence to hypertension medication (possible subscale scores range from 0-21), physical activity engagement (possible subscale scores range from 0-14), eating a healthy diet (possible subscale scores range from 0-77), alcohol intake (possible subscale scores range from 0-1), tobacco exposure (possible subscale scores range from 0-14), and weight management (possible subscale scores range from 10-50). Possible cumulative adherence (index) scores range from 0-6 where higher scores indicate better adherence.
Measured: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
HTN self-management is measured by the HTN Self-Care Activity Level Effects measure. The Hypertension Self-Care Activity Level Effects (H-SCALE) questionnaire assesses adherence to hypertension medication (possible subscale scores range from 0-21), physical activity engagement (possible subscale scores range from 0-14), eating a healthy diet (possible subscale scores range from 0-77), alcohol intake (possible subscale scores range from 0-1), tobacco exposure (possible subscale scores range from 0-14), and weight management (possible subscale scores range from 10-50). Possible cumulative adherence (index) scores range from 0-6 where higher scores indicate better adherence.
Measured: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start5 Apr 2024
- Primary completion11 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
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
- NCT05671302
- Sponsor's protocol ID
- STU-2022-0568
- Other IDs
- R21MD017658-01
- Status last verified
- Sep 2025
- First submitted
- 13 Oct 2022
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35227154
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walk Together: A Family-Based Intervention for Hypertension In African Americans
- ClinicalTrials.gov ID
- NCT05671302
- Acronym / sponsor ID
- STU-2022-0568
- Conditions
- Hypertension, Family Relations
- Keywords
- Family support, Integrated health care systems, Healthy lifestyle, Community-based participatory research, African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 4 Jan 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walk Together | Experimental | Behavioral: Walk TogetherWalk 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
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 TogetherReceive 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. | Behavioural | Walk Together |
Primary outcome
Feasibility of intervention as measured by the number of participants accrued
Time frame: 11 months
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
Feasibility of intervention as measured by the rate of refusal among eligible patients/family members
Time frame: 11 months
Feasibility of intervention is measured by the rate of refusal among eligible patients/family members which is the number of participants refusing to consent
Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components
Time frame: 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 participants completing post-treatment assessments
Time frame: 11 months
Adherence to the intervention as measured by the proportion of participants completing post-treatment assessment
Attrition as measured by the proportion of consented participants who dropped out of the entire study
Time frame: 11 months
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
Acceptability of intervention as measured by 8-item Client Satisfaction Questionnaire
Time frame: Protocol completion (approx. 24 months)
Acceptability of intervention is measured by 8-item Client Satisfaction Questionnaire. Possible scores range from 8 to 32, with higher values indicating higher satisfaction
12 secondary outcomes
Family relationship quality as measured by the FACES-IV Short Form at Baseline
Time frame: Baseline
Family relationship quality as measured by the FACES-IV Short Form at following session 3
Time frame: 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
Time frame: 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
Time frame: Baseline
Family relationship quality as measured by the Chronic Illness Resources Survey following session 3
Time frame: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
Family relationship quality as measured by the Chronic Illness Resources Survey following session 4
Time frame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale at Baseline
Time frame: Baseline
Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 3
Time frame: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 4
Time frame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
Time frame: Baseline
HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
Time frame: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
Time frame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 35227154Woods 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 in people with Hypertension and Family Relations, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 17 Sep 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention as measured by the number of participants accrued (time frame: 11 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671302, which also lists 1 linked publication.
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 17 Sep 2025.