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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
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.
UT Southwestern Family Medicine Clinic at Texas Health Dallas
Dallas, Texas, United States
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
Time frame: 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
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 dyads successfully completing the four intervention components
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Protocol completion (approx. 24 months)
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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.
Time frame: 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.
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
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.
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
Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
Time frame: 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.
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
Family relationship quality is measured by the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate better outcome.
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
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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
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
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.
Time frame: Following session 4 (Booster Check-in session, approx. 7-8 weeks after Baseline)