- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07623291
Monitoring Blood Pressure at Home and Pharmacy Telehealth (REMAP-BP)
REmote Blood Pressure Monitoring and Pharmacist-Led Telehealth Program in an Emergency Department Transitional Care Clinic
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For all participants:
- Participants will receive information on the importance of measuring blood pressure and ways to improve blood pressure.
- Participants will complete questionnaires describing current socioeconomic position, medical history and healthcare needs.
- Participants will come in for three research clinic visits to get blood pressure measured 3 months after enrollment in this study, and 6 months after enrollment in this study.
For participants asked to measure blood pressure at home:
- Measure blood pressure twice a day at home, following the instructions provided. The study will provide participants with the device and send text message reminders each week day. Participants will return the device at study visit 3 months from now.
- Following the instructions provided, participants will talk to a pharmacist over the phone weekly to discuss blood pressure and medications. All medication changes will be discussed with a collaborating physician.
- Participants will complete questionnaires and interviews on satisfaction with the program.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bernadette Johnson
- Phone Number: 205-934-7329
- Email: bajohnson@uabmc.edu
Study Contact Backup
- Name: Tammi Thomas
- Phone Number: 205-934-7839
- Email: tammithomas@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
Contact:
- Bernadette Johnson
- Phone Number: 205-934-7329
- Email: bajohnson@uabmc.edu
-
Contact:
- Tammi Thomas
- Phone Number: 205-934-7839
- Email: tammithomas@uabmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years
- Ability to speak English
- Seen at UAB's or TGH's Emergency Department-Transitional Care Clinic
- Blood pressure at Emergency Department-Transitional Care Clinic: Systolic BP ≥ 130 mmHg or Diastolic BP ≥ 80 mmHg
- Have a cellphone with video capability
Exclusion Criteria:
- 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
- Currently pregnant or breastfeeding
- Arm circumference >50 cm. *The upper limit for the largest BP cuff for oscillometric BP devices is typically 50-52 cm; data from the National Health and Nutrition Examination Survey, 2011-2016 indicated that <1% of US adults have an arm circumference >50 cm, so this will have minimal effect on our study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Remote Blood Pressure Monitoring + Telehealth
Participants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management
|
Participants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management
|
|
No Intervention: Usual Care
Participants receive usual care from providers to manage blood pressure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Number of Enrolled Participants with Blood Pressure Control
Time Frame: 12 weeks (3 months) from randomization
|
The number of enrolled participants with blood pressure control
|
12 weeks (3 months) from randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants in the Intervention with Patient-Reported Outcomes
Time Frame: 24 weeks (6 months) from randomization
|
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. |
24 weeks (6 months) from randomization
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lama Ghazi, MD, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300016615
- National Heart, Lung, & Blood (Other Identifier: National Heart, Lung, and Blood Institute (NHLBI))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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