[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561665":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":69,"studyPopulation":66,"armGroups":70,"interventions":83,"overallOfficials":97,"centralContacts":101,"locations":107,"responsibleParty":124,"collaborators":66,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":90,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":66,"enrollmentInfo":135,"targetDuration":66,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":148,"whyStopped":66,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":48},[9,12,14,16,18,21,24],{"measure":10,"description":10,"timeFrame":11},"Proportion of patients who are screened","Month 6",{"measure":13,"description":13,"timeFrame":11},"Proportion of patients who are eligible",{"measure":15,"description":15,"timeFrame":11},"Proportion of patients who agree to participate",{"measure":17,"description":17,"timeFrame":11},"Proportion of patients who decline",{"measure":19,"description":20,"timeFrame":11},"Number of staff needed and time spent for intervention","staff training, technical support, troubleshooting",{"measure":22,"description":23,"timeFrame":11},"Proportion of completed self-measurement of Blood Pressure at home","Proportion of completed self-measurement of BP at home",{"measure":25,"description":25,"timeFrame":11},"Proportion of completed self-management contacts.",[27,30,33,36,39,42,45],{"measure":28,"description":29,"timeFrame":11},"Change in Blood Pressure","Effect size for BP change at 6-months (both arms)",{"measure":31,"description":32,"timeFrame":11},"Medication adherence","Medication adherence using the Proportion of Days Covered and Domains of Subjective Extent of Nonadherence Measure (both arms)",{"measure":34,"description":35,"timeFrame":11},"Feasibility of Intervention Measure [FIM]","measured on a 5-point Likert scale - 'excellent', 'good', 'fair' or 'poor' - higher scores denotes better feasibility",{"measure":37,"description":38,"timeFrame":11},"Acceptability of Intervention Measure [AIM]","Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree)",{"measure":40,"description":41,"timeFrame":11},"Intervention Appropriateness Measure [IAM]","The IAM uses a 5-point Likert scale, with scores ranging from \"Completely Disagree\" to \"Completely Agree\". The mean of the scores is calculated to determine the overall score.",{"measure":43,"description":44,"timeFrame":11},"Patient Assessment of Chronic Illness Care [PACIC]","The Patient Assessment of Chronic Illness Care (PACIC) is scored by averaging the responses to all 20 items on the scale. The score ranges from 1 to 5, with higher scores indicating that patients feel more involved in their care and self-management.",{"measure":46,"description":47,"timeFrame":11},"Organizational Readiness for Implementing Change [ORIC]","Organizational Readiness for Implementing Change (ORIC) is a 12-item instrument used to determine how well employees at an organization feel they can implement the change in processes required by a proposed intervention. Each item includes a Likert scale from 1 (Disagree) to 5 (Agree) - The range of each scale is -10 through 0 to +10. A negative scale score reflects an overall disagreement with items measuring the stage of change, whereas a positive score represents overall agreement.",[49,52,55,58],{"measure":50,"description":51,"timeFrame":11},"Number of clinic, urgent care and emergency department visits","Number of clinic, urgent care and emergency department visits from Electronic Medical Records (both arms).",{"measure":53,"description":54,"timeFrame":11},"Patient self-reported home BP monitor use","Patient self-reported home BP monitor use and self-management referrals from EMR (usual care group only).",{"measure":56,"description":57,"timeFrame":11},"Reasons for patient contact","Reasons for patient contact (scheduled, unscheduled calls \\[e.g., technical, intervention or safety related\\]) (TM-HTN arm only)",{"measure":59,"description":60,"timeFrame":11},"patients with resistant hypertension","Subgroup analysis in patients with resistant hypertension",{"allocation":62,"interventionModel":63,"interventionModelDescription":64,"primaryPurpose":65,"observationalModel":66,"timePerspective":66,"maskingInfo":67},"RANDOMIZED","PARALLEL","60 patients total (30 in the TM-HTN intervention group, 30 in the control group).","SUPPORTIVE_CARE",null,{"masking":68,"maskingDescription":66,"whoMasked":66},"NONE","Telemedicine management of HTN (TM-HTN) can augment and overcome challenges by allowing more support for patients' HTN self-care skills, providing multiple home Blood Pressure values and overcoming failure to appropriately intensify treatment. TM-HTN consists of 1) home BP monitoring, 2) home BP based pharmacotherapy, and 3) telemedicine-based self-management support.",[71,77],{"label":72,"type":73,"description":74,"interventionNames":75},"Telemedicine management of Hypertension intervention group","EXPERIMENTAL","BP monitor and telehealth application Home BP monitoring Pharmacotherapy Telemedicine-based self-management support Additional support in-person training",[76],"Behavioral: Telemedicine management of Hypertension",{"label":78,"type":79,"description":80,"interventionNames":81},"control group","PLACEBO_COMPARATOR","This includes usual clinic based Hypertension care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice.",[82],"Behavioral: Usual Care",[84,91],{"type":85,"name":86,"description":87,"armGroupLabels":88,"otherNames":89},"BEHAVIORAL","Telemedicine management of Hypertension","TM-HTN intervention includes tailored and frequent self-management support, home blood pressure monitoring, pharmacotherapy, and as-needed assistance for health-related social needs provided by pharmacists, nurses, community health workers, and social workers. This will be compared with usual care",[72],[90],"TM-HTN",{"type":85,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"Usual Care","This includes usual clinic based HTN care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice.",[78],[96],"Control Group",[98],{"name":99,"affiliation":5,"role":100},"Yashashwi Pokharel, MD","PRINCIPAL_INVESTIGATOR",[102],{"name":103,"role":104,"phone":105,"phoneExt":66,"email":106},"Camelia Singletary, MPH","CONTACT","336.713.7210","Camelia.Singletary@Advocatehealth.org",[108],{"facility":5,"status":66,"city":109,"state":110,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"Winston-Salem","North Carolina","27157","United States","US",{"type":115,"coordinates":116},"Point",[117,118],-80.24422,36.09986,{"lat":118,"lon":117},[121,123],{"name":103,"role":104,"phone":122,"phoneExt":66,"email":106},"336-713-7210",{"name":99,"role":100,"phone":66,"phoneExt":66,"email":66},{"type":125,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100561665","tailoring-tm-htn-intervention-for-black-patients-100561665",false,"NCT06593119","Tailoring TM-HTN Intervention for Black Patients","Tailoring a Telemedicine Hypertension Management Intervention for Black Patients","Inclusion Criteria:\n\n* Subjects must be African American or Black\n* experiencing socially disadvantage\n* Patients with systolic Blood Pressure ≥140 mmHg on their last two clinic visits and baseline systolic BP \\>130 mmHg using the mean of two research BP values measured by trained staff\n* Subjects must be on stable Blood Pressure medications for the preceding 6 weeks\n\nExclusion Criteria:\n\n* Unable to read or speak English\n* diminished ability to measure home Blood Pressure\n* chronic kidney disease ≥stage 4\n* persistent\u002Fchronic atrial fibrillation\n* severe hypertension \\>180\u002F110 mmHg\n* acute health changes in past 3 months increasing chance of Blood Pressure instability\n* terminal illness","ALL","18 Years",{"count":136,"type":137},60,"ESTIMATED","INTERVENTIONAL",[140],"NA","Current clinic-based hypertension (HTN) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (BP) control.",[143],"Hypertension",[145,146,147],"Telemedicine","socially disadvantaged","African American or Black patients","NOT_YET_RECRUITING","2026-07-27",{"date":151,"type":152},"2026-07-29","ACTUAL",{"date":154,"type":137},"2026-09",{"date":156,"type":137},"2028-09",{"name":5,"class":6},1]