Monitoring Blood Pressure at Home and Pharmacy Telehealth Among People Living With HIV
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
The overall goal of this project is to determine if measuring blood pressure at home and staying in contact with a team of pharmacists and physicians to manage participants' blood pressure is useful. The study will enroll 552 participants who are seen at the University of Alabama at Birmingham 1917 Dewberry Clinic and Vanderbilt Comprehensive Care Center. Half of the participants (276 patients) will be asked to measure blood pressure at home, and half of the participants (276 patients) will continue to receive usual care. Participants who measure blood pressure at home will also meet with a pharmacist weekly over the phone to discuss blood pressure readings and have blood pressure medications prescribed if needed. This program will last 6 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Ability to speak English
Seen at UAB's 1917 Dewberry Clinic or Vanderbilt's Comprehensive Care Clinic
Blood pressure at Clinic: Systolic BP ≥ 130 mmHg or Diastolic BP ≥ 80 mmHg
Disqualifiers
Systolic BP ≥ 160 mmHg or Diastolic BP ≥ 100 mmHg (i.e. severe range hypertension (HTN) by the 2025 American College of Cardiology/American Heart Association BP guidelines) as they typically are referred to immediate treatment intensification. Since the prevalence of severe HTN is low (i.e.<5%) in the US population, exclusion of these individuals will have only a small effect on the study.)
Lack of willingness or inability to provide written informed consent
Individuals who work overnight or second shift
History of known major arrhythmias
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Blood Pressure Monitoring + Telehealth
BehavioralParticipants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management
Treatment groups
572 Participants
are divided into 2 treatment groupsGroup A: Remote Blood Pressure Monitoring + TelehealthActive comparator 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Total Number of Enrolled Participants with Blood Pressure Control
The number of enrolled participants with blood pressure control
Time frame
Time Frame: 12 weeks (3 months) from randomizationSecondary outcomes
1
Number of Participants in the Intervention with Patient-Reported Outcomes
The number of participants with completed qualitative interviews and surveys regarding intervention adherence and satisfaction. The survey will assess intervention adherence and satisfaction using the following scales: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and the Feasibility of Intervention Measure (FIM). The AIM is a 4-item scale where the min. value per item is 1 and the max. value per item is 5. A higher total score indicates better acceptability while the lower total score indicates worse acceptability. The IAM is a 4-item scale where the min. value per item is 1 and the max. value per item is 5. A higher total score indicates better appropriateness while the lower total score indicates worse appropriateness. The FIM is a 4-item scale where the min. value per item is 1 and the max. value per item is 5. A higher total score indicates better feasibility while the lower total score indicates worse feasibility.
Time frame
Time Frame: 24 weeks (6 months) from randomizationLocations
Sponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov
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