Clinical trial NCT05671302: Walk Together: A Family-Based Intervention for Hypertension In African Americans
Official title: Walk Together: A Family-Based Intervention for Hypertension In African Americans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Family Relations
Keywords: Family support
Integrated health care systems
Healthy lifestyle
Community-based participatory research
African Americans
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-01-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine the feasibility and acceptability of a novel family-based hypertension self-management intervention, Walk Together, adapted from an existing empirically-supported dyadic intervention, for implementation in primary care.

Detailed description: Hypertension is the driving risk factor for disparities in mortality and life expectancy between African Americans and Whites. Hypertension self-management (including blood pressure monitoring, diet, exercise, and other lifestyle changes) is critical for improving hypertension control, and prior interventions have emphasized promoting patient-level behavior change to improve self-management adherence. Though family members make substantial contributions to hypertension self-management for African Americans, family support is consistently underutilized by current hypertension self-management interventions. Family-based interventions for improving self-management are effective for other chronic conditions, including for African Americans. Evidence has demonstrated the unique and important role of family support in African Americans' hypertension management, and African Americans' preferences for the direct involvement of family in hypertension interventions. The study team will develop a family-based hypertension self-management intervention ("Walk Together") for African Americans with uncontrolled hypertension that integrates community-based participatory perspectives in the specifics of the intervention. The study team will pilot trial the culturally-adapted intervention in a primary care setting in order to examine the feasibility and acceptability of the Walk Together protocol.

Eligibility criteria: Inclusion Criteria:

* Black or African American
* Age 18 to 75
* Two blood pressure values ≥ 130/ ≥ 80 in 12 months prior
* Available family support person to join the intervention who agrees to participate
* English-speaking

Exclusion Criteria:

* Family support person is under the age of 18
* Documented cognitive impairment in patient's medical record
* Presence of severe psychiatric condition (i.e., current psychotic disorder or suicidality)
* Participation in prior hypertension health education intervention
* Prior participation in formative study activities (i.e., study focus groups)

Primary outcomes:
measure: Feasibility of intervention as measured by the number of participants accrued
timeFrame: 11 months
measure: Feasibility of intervention as measured by the rate of refusal among eligible patients/family members
timeFrame: 11 months
measure: Adherence to the intervention as measured by the proportion of dyads successfully completing the four intervention components
timeFrame: 11 months
measure: Adherence to the intervention as measured by the proportion of participants completing post-treatment assessments
timeFrame: 11 months
measure: Attrition as measured by the proportion of consented participants who dropped out of the entire study
timeFrame: 11 months
measure: Acceptability of intervention as measured by 8-item Client Satisfaction Questionnaire
timeFrame: Protocol completion (approx. 24 months)
Secondary outcomes:
measure: Family relationship quality as measured by the FACES-IV Short Form at Baseline
timeFrame: Baseline
measure: Family relationship quality as measured by the FACES-IV Short Form at following session 3
timeFrame: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
measure: Family relationship quality as measured by the FACES-IV Short Form at following session 4
timeFrame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
measure: Family relationship quality as measured by the Chronic Illness Resources Survey at Baseline
timeFrame: Baseline
measure: Family relationship quality as measured by the Chronic Illness Resources Survey following session 3
timeFrame: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
measure: Family relationship quality as measured by the Chronic Illness Resources Survey following session 4
timeFrame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
measure: Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale at Baseline
timeFrame: Baseline
measure: Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 3
timeFrame: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
measure: Health knowledge as measured by the Hypertension (HTN) Evaluation of Lifestyle and Management Knowledge scale following session 4
timeFrame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
measure: HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
timeFrame: Baseline
measure: HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
timeFrame: Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
measure: HTN self-management as measured by the HTN Self-Care Activity Level Effects measure at Baseline
timeFrame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Family Medicine Clinic at Texas Health Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Sarah Woods, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.