Walk Together Efficacy Trial
ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Black or African American
Age 18 to 75
Diagnosis of essential hypertension
Two clinic-based blood pressure values ≥ 130/ ≥ 80 in 12 months prior
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Walk Together
BehavioralWalk 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 education
BehavioralHypEd 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 NHLBI'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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Walk TogetherExperimental treatment 1 intervention
Group B: Hypertension Education (HypEd)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 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.
Time frame
Baseline2
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 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.
Time frame
Following session 3 (approx. 3 weeks after Baseline)3
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 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.
Time frame
Following session 4 (approx. 7-10 weeks after Baseline)4
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 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.
Time frame
1 month post-protocol (approximately 3 months after Baseline)Secondary outcomes
1
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; a cutoff score of greater than or equal to 13.5 indicates relationship distress.
Time frame
Baseline2
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; a cutoff score of greater than or equal to 13.5 indicates relationship distress.
Time frame
Following session 3 (approx. 3 weeks after Baseline)3
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; a cutoff score of greater than or equal to 13.5 indicates relationship distress.
Time frame
Following session 4 (approx. 7-10 weeks after Baseline)4
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; a cutoff score of greater than or equal to 13.5 indicates relationship distress.
Time frame
1 month post-protocol (approximately 3 months after Baseline)Other outcomes
1
Hypertension knowledge as measured by the Hypertension Evaluation of Lifestyle and Management Knowledge Scale
Family support persons' 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.
Time frame
Baseline2
Hypertension knowledge as measured by the Hypertension Evaluation of Lifestyle and Management Knowledge Scale
Family support persons' 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.
Time frame
Following session 3 (approx. 3 weeks after Baseline)3
Hypertension knowledge as measured by the Hypertension Evaluation of Lifestyle and Management Knowledge Scale
Family support persons' 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.
Time frame
Following session 4 (approx. 7-10 weeks after Baseline)4
Hypertension knowledge as measured by the Hypertension Evaluation of Lifestyle and Management Knowledge Scale
Family support persons' 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.
Time frame
1 month post-protocol (approximately 3 months after Baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: