Tailoring TM-HTN Intervention for Black Patients
ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must be African American or Black
experiencing socially disadvantage
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
Subjects must be on stable Blood Pressure medications for the preceding 6 weeks
Disqualifiers
Unable to read or speak English
diminished ability to measure home Blood Pressure
chronic kidney disease ≥stage 4
persistent/chronic atrial fibrillation
Trial design
Design model
Parallel
Treatments tested in this trial
Telemedicine management of Hypertension
BehavioralTM-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
Usual Care
BehavioralThis 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Telemedicine management of Hypertension intervention groupExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients who are screened
Proportion of patients who are screened
Time frame
Month 62
Proportion of patients who are eligible
Proportion of patients who are eligible
Time frame
Month 63
Proportion of patients who agree to participate
Proportion of patients who agree to participate
Time frame
Month 64
Proportion of patients who decline
Proportion of patients who decline
Time frame
Month 6Secondary outcomes
1
Change in Blood Pressure
Effect size for BP change at 6-months (both arms)
Time frame
Month 62
Medication adherence
Medication adherence using the Proportion of Days Covered and Domains of Subjective Extent of Nonadherence Measure (both arms)
Time frame
Month 63
Feasibility of Intervention Measure [FIM]
measured on a 5-point Likert scale - 'excellent', 'good', 'fair' or 'poor' - higher scores denotes better feasibility
Time frame
Month 64
Acceptability of Intervention Measure [AIM]
Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree)
Time frame
Month 6Other outcomes
1
Number of clinic, urgent care and emergency department visits
Number of clinic, urgent care and emergency department visits from Electronic Medical Records (both arms).
Time frame
Month 62
Patient self-reported home BP monitor use
Patient self-reported home BP monitor use and self-management referrals from EMR (usual care group only).
Time frame
Month 63
Reasons for patient contact
Reasons for patient contact (scheduled, unscheduled calls \[e.g., technical, intervention or safety related\]) (TM-HTN arm only)
Time frame
Month 64
patients with resistant hypertension
Subgroup analysis in patients with resistant hypertension
Time frame
Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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