Walk Together: A Family-Based Intervention for Hypertension In African Americans

Hypertension Clinical Trial

Official title:

Walk Together: A Family-Based Intervention for Hypertension In African Americans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671302
• Other study ID #: STU-2022-0568
• Secondary ID: R21MD017658-01
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Sarah B Woods, PhD
• Phone: 214-648-6225
• Email: Sarah.Woods[@]UTsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: February 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Family Relations
• Hypertension

Intervention

Behavioral:
• Walk Together
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.

Locations

Country	Name	City	State
United States	UT Southwestern Family Medicine Clinic at Texas Health Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	11 months
Primary	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	11 months
Primary	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	11 months
Primary	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	11 months
Primary	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	11 months
Primary	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	Protocol completion (approx. 24 months)
Secondary	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.	Baseline
Secondary	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.	Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
Secondary	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.	Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
Secondary	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.	Baseline
Secondary	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.	Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
Secondary	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.	Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
Secondary	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.	Baseline
Secondary	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.	Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
Secondary	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.	Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)
Secondary	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.	Baseline
Secondary	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.	Following session 3 (Feedback Session, approx. 2-3 weeks after Baseline)
Secondary	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.	Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)