[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658322":3},{"organization":4,"outcomesModule":7,"designInfo":127,"detailedDescription":136,"studyPopulation":130,"armGroups":137,"interventions":150,"overallOfficials":159,"centralContacts":163,"locations":169,"responsibleParty":183,"collaborators":186,"id":190,"slug":191,"hasResults":192,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":130,"eligibilityCriteria":195,"healthyVolunteers":192,"sex":196,"minAge":197,"maxAge":198,"enrollmentInfo":199,"targetDuration":130,"studyType":202,"phases":203,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":216,"whyStopped":130,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":47,"otherOutcomes":76},[9,13,15,17,19,21,24,25,26,27,28,31,33,35,37,39,41,43,45],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline",{"measure":10,"description":11,"timeFrame":14},"Following session 3 (approx. 3 weeks after Baseline)",{"measure":10,"description":11,"timeFrame":16},"Following session 4 (approx. 7-10 weeks after Baseline)",{"measure":10,"description":11,"timeFrame":18},"1 month post-protocol (approximately 3 months after Baseline)",{"measure":10,"description":11,"timeFrame":20},"6 months post-protocol (approximately 9 months after Baseline)",{"measure":22,"description":23,"timeFrame":12},"Hypertension self-management behavior adherence as measured by blood pressure monitor use adherence","Hypertension self-management adherence will be, in part, assessed via adherence to blood pressure monitor (BPM) use calculated as (a) the ratio of days patient participants use their study-provided BPM to days enrolled in the study and (b) dichotomizing BPM use at greater than or equal to 70% versus less than 70% of enrolled days",{"measure":22,"description":23,"timeFrame":14},{"measure":22,"description":23,"timeFrame":16},{"measure":22,"description":23,"timeFrame":18},{"measure":22,"description":23,"timeFrame":20},{"measure":29,"description":30,"timeFrame":12},"Blood pressure control","Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and\u002For diastolic BP less than or equal to 80) using an average of readings completed within 7 days of the primary outcome timeframe.",{"measure":29,"description":30,"timeFrame":32},"1 month (readings completed within 7 days of session 3)",{"measure":29,"description":30,"timeFrame":34},"2 months (readings completed within 7 days of session 4)",{"measure":29,"description":30,"timeFrame":36},"1 month post-protocol (approximately 3 months after Baseline, using 7-day averages)",{"measure":29,"description":30,"timeFrame":38},"6 months post-protocol (approximately 9 months after Baseline, using 7-day averages)",{"measure":29,"description":40,"timeFrame":12},"Patients will be asked to complete three consecutive measurements, once daily, in the morning. We will average all three measurements and the last two measurements at each distinct measurement timepoint (i.e., each day the study-provided blood pressure monitor is used) and assess blood pressure (BP) control (indicated by systolic BP less than or equal to 130 and\u002For diastolic BP less than or equal to 80) using an average of readings completed across 30 days (1 month) of the primary outcome timeframe.",{"measure":29,"description":40,"timeFrame":42},"Month 1",{"measure":29,"description":40,"timeFrame":44},"Month 2",{"measure":29,"description":40,"timeFrame":46},"Month 7",[48,51,52,53,54,55,58,59,60,61,62,65,66,67,68,69,72,73,74,75],{"measure":49,"description":50,"timeFrame":12},"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.",{"measure":49,"description":50,"timeFrame":14},{"measure":49,"description":50,"timeFrame":16},{"measure":49,"description":50,"timeFrame":18},{"measure":49,"description":50,"timeFrame":20},{"measure":56,"description":57,"timeFrame":12},"Family relationship quality as measured by the FACES-IV Short Form","Family relationship quality (broadly, in family relationships specified by the participant) is measured by the 24-item, 8-subscale Family Adaptability and Cohesion Scale IV (FACES-IV) Short Form (FACES IV-SF). Possible scores range from 3-15 for each subscale where higher scores indicate higher levels of the subscale's dimension.",{"measure":56,"description":57,"timeFrame":14},{"measure":56,"description":57,"timeFrame":16},{"measure":56,"description":57,"timeFrame":18},{"measure":56,"description":57,"timeFrame":20},{"measure":63,"description":64,"timeFrame":12},"Family support for hypertension self-management behavior as measured by the Chronic Illness Resources Survey","Family support for hypertension management is measured by the family and friends subscale of the Chronic Illness Resources Survey. Possible scores range from 1-5 where higher scores indicate greater support.",{"measure":63,"description":64,"timeFrame":14},{"measure":63,"description":64,"timeFrame":16},{"measure":63,"description":64,"timeFrame":18},{"measure":63,"description":64,"timeFrame":20},{"measure":70,"description":71,"timeFrame":12},"Hypertension knowledge as measured by the HTN Evaluation of Lifestyle and Management Knowledge Scale","Patients' 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.",{"measure":70,"description":71,"timeFrame":14},{"measure":70,"description":71,"timeFrame":16},{"measure":70,"description":71,"timeFrame":18},{"measure":70,"description":71,"timeFrame":20},[77,80,81,82,83,84,87,89,90,91,92,95,96,97,98,99,102,103,104,105,106,109,110,111,112,113,116,117,118,119,120,123,124,125,126],{"measure":78,"description":79,"timeFrame":12},"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.",{"measure":78,"description":79,"timeFrame":14},{"measure":78,"description":79,"timeFrame":16},{"measure":78,"description":79,"timeFrame":18},{"measure":78,"description":79,"timeFrame":20},{"measure":85,"description":86,"timeFrame":12},"Health behavior as measured by the Hypertension Self-Care Activity Level Effects (H-SCALE)","Health behaviors reflecting hypertension self-management adherence for family support persons living with hypertension 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.",{"measure":85,"description":86,"timeFrame":88},"Following session 3 (approx. 3 weeks after baseline)",{"measure":85,"description":86,"timeFrame":16},{"measure":85,"description":86,"timeFrame":18},{"measure":85,"description":86,"timeFrame":20},{"measure":93,"description":94,"timeFrame":12},"Health behavior as measured by the PhenX smoking status protocol","Family support persons' health behavior will be measured in part by the PhenX cigarette smoking status protocol questionnaire which assesses current, past-year, and historical smoking behavior.",{"measure":93,"description":94,"timeFrame":88},{"measure":93,"description":94,"timeFrame":16},{"measure":93,"description":94,"timeFrame":18},{"measure":93,"description":94,"timeFrame":20},{"measure":100,"description":101,"timeFrame":12},"Health behavior as measured by the PhenX alcohol use protocol","Family support persons' health behavior will be measured in part by the PhenX alcohol 30-day quantity and frequency protocol questionnaire which assesses lifetime and past-month use of alcohol.",{"measure":100,"description":101,"timeFrame":88},{"measure":100,"description":101,"timeFrame":16},{"measure":100,"description":101,"timeFrame":18},{"measure":100,"description":101,"timeFrame":20},{"measure":107,"description":108,"timeFrame":12},"Health behavior as measured by the PhenX dietary intake protocol","Family support persons' health behavior will be measured in part by the PhenX dietary intake protocol questionnaire which assesses past-month frequency of intake of various food items.",{"measure":107,"description":108,"timeFrame":88},{"measure":107,"description":108,"timeFrame":16},{"measure":107,"description":108,"timeFrame":18},{"measure":107,"description":108,"timeFrame":20},{"measure":114,"description":115,"timeFrame":12},"Health behavior as measured by the PhenX physical activity protocol","Family support persons' health behavior will be measured in part by the PhenX comprehensive adult physical activity protocol questionnaire which assesses past-year frequency of physical activity.",{"measure":114,"description":115,"timeFrame":88},{"measure":114,"description":115,"timeFrame":16},{"measure":114,"description":115,"timeFrame":18},{"measure":114,"description":115,"timeFrame":20},{"measure":121,"description":122,"timeFrame":12},"Health behavior as measured by the PhenX medication adherence protocol","Family support persons' health behavior will be measured in part by the PhenX adherence to medication regimen protocol questionnaire which assesses medication adherence and ability to refill prescriptions on schedule.",{"measure":121,"description":122,"timeFrame":88},{"measure":121,"description":122,"timeFrame":16},{"measure":121,"description":122,"timeFrame":18},{"measure":121,"description":122,"timeFrame":20},{"allocation":128,"interventionModel":129,"interventionModelDescription":130,"primaryPurpose":131,"observationalModel":130,"timePerspective":130,"maskingInfo":132},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":133,"maskingDescription":130,"whoMasked":134},"SINGLE",[135],"OUTCOMES_ASSESSOR","Hypertension is the most significant risk factor for racial disparities in mortality and life expectancy. African Americans, in particular, are at greater risk of developing hypertension earlier and experiencing worse hypertension-related outcomes. Hypertension is also a modifiable risk factor for cardiovascular disease, in part via self-management behavior which is critical for achieving hypertension control. Black and African American individuals often report difficulties with self-management adherence due in part to challenges in sustaining necessary lifestyle changes, and environmental barriers to engaging in self-care. African Americans also frequently report family emotional and behavioral support is critical for achieving self-management goals, while shared health behaviors, insufficient support, and family stress are often identified as barriers to self-management. Yet, family support has remained an untapped resource in hypertension self-management interventions. This study will test the efficacy of a new family-based hypertension self¬-management intervention which was designed and adapted with and for Black and African American primary care patients living with uncontrolled hypertension and their family support persons via prior community-based participatory research. The intervention -- Walk Together -- includes four dyadic (i.e., patient plus family support person) sessions over approximately eight weeks with the goal of optimizing family relationship quality including family support for hypertension self-management, plus improving hypertension knowledge, while addressing common barriers to hypertension management via referrals to standard of care resources, health information technology, and integration into patients' primary care clinics. Using a randomized controlled trial design, we will (1) identify the extent to which the Walk Together intervention increases hypertension self-management adherence and improves blood pressure control compared to a hypertension education control condition (HypEd); (2) examine family support (i.e., patient-family support person relationship quality, and family support for hypertension management behaviors) and hypertension knowledge as mechanisms of effect through which Walk Together leads to improvements in self-management adherence and blood pressure control outcomes; and, (3) evaluate the family-level positive health impacts of the Walk Together intervention on participating family support persons' hypertension knowledge and health behaviors.",[138,144],{"label":139,"type":140,"description":141,"interventionNames":142},"Walk Together","EXPERIMENTAL","Walk Together incudes four dyadic sessions, integrated into patients' primary care, to improve hypertension self-management adherence and blood pressure control via optimizing family relationship quality and increasing hypertension knowledge.",[143],"Behavioral: Walk Together",{"label":145,"type":146,"description":147,"interventionNames":148},"Hypertension Education (HypEd)","SHAM_COMPARATOR","Hypertension education control condition includes four points of contact providing hypertension education and follow-up regarding hypertension self-management.",[149],"Behavioral: Hypertension education",[151,155],{"type":152,"name":139,"description":153,"armGroupLabels":154,"otherNames":130},"BEHAVIORAL","Walk 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.",[139],{"type":152,"name":156,"description":157,"armGroupLabels":158,"otherNames":130},"Hypertension education","HypEd 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.",[145],[160],{"name":161,"affiliation":5,"role":162},"Sarah Woods, PhD","PRINCIPAL_INVESTIGATOR",[164],{"name":165,"role":166,"phone":167,"phoneExt":130,"email":168},"Study Coordinator","CONTACT","214-645-9532","WalkTogether@UTSouthwestern.edu",[170],{"facility":171,"status":130,"city":172,"state":173,"zip":174,"country":175,"countryCode":176,"cosmosGeoPoint":177,"geoPoint":182,"contacts":130},"UT Southwestern Department of Family and Community Medicine","Dallas","Texas","75390","United States","US",{"type":178,"coordinates":179},"Point",[180,181],-96.80667,32.78306,{"lat":181,"lon":180},{"type":162,"investigatorFullName":184,"investigatorTitle":185,"investigatorAffiliation":5,"oldNameTitle":130,"oldOrganization":130},"Sarah Woods","Principal Investigator",[187],{"name":188,"class":189},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100658322","walk-together-efficacy-trial-100658322",false,"NCT07849920","Walk Together Efficacy Trial","Inclusion Criteria:\n\n* Black or African American\n* Age 18 to 75\n* Diagnosis of essential hypertension\n* Two clinic-based blood pressure values ≥ 130\u002F ≥ 80 in 12 months prior\n* Available family support person to join the study who agrees to participate\n* English-speaking\n\nExclusion Criteria:\n\n* Diagnosis of hypertension is made exclusively during pregnancy\n* Documented cognitive impairment in patient's medical record\n* Presence of severe psychiatric condition (i.e., current psychotic disorder or suicidality)\n* Diagnosis of sustained atrial fibrillation\n* Past-year myocardial infarction\n* Diagnosis of chronic kidney disease (eGFR \\\u003C20)\n* Malignancy (other than non-melanoma skin cancer) in past 2 years\n* Prior organ transplant\n* Prior participation in earlier Walk Together studies\n* Participation in prior hypertension health education intervention\n* Family support person is under the age of 18 or over age of 25","ALL","18 Years","75 Years",{"count":200,"type":201},400,"ESTIMATED","INTERVENTIONAL",[204],"NA","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:\n\n* Do patients and family members who complete Walk Together take better care of their health?\n* 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.\n\nParticipants will:\n\n* Complete four study sessions over 7 to 10 weeks\n* Measure their blood pressure at home\n* Answer questions about their family and their health 6 times over 8 months",[207],"Hypertension",[209,210,211,207,212,213,214,215],"Family support","Integrated health care systems","Healthy lifestyle","Community-based participatory research","Primary care","African American","Blood pressure","NOT_YET_RECRUITING","2026-09-24",{"date":219,"type":220},"2026-09-30","ACTUAL",{"date":222,"type":201},"2027-01-18",{"date":224,"type":201},"2031-04-18",{"name":5,"class":6},1]