Monitoring Blood Pressure at Home
Post-Emergency Department Discharge Clinic Telehealth Program for Patients With Uncontrolled Hypertension: a Pilot Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
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 one research clinic visit to get blood pressure measured 3 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 on satisfaction with the program.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Lama Ghazi, MD, PhD
- Phone Number: 205-552-3045
- Email: lghazi@uab.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients seen at the Emergency Department Post-Discharge Clinic
- >=18 years
- Blood pressure >=130/80 mmHg and <=160/100 mmHg
- English speakers
- Have a smartphone
Exclusion Criteria:
- Patients with blood pressure >=160 mmHg
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Usual Care
Participants receive usual care from providers to manage their blood pressure
|
Participants receive usual care, no intervention.
|
|
Active Comparator: Remote Blood Pressure Monitoring + Telehealth
Participants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management
|
Remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Number of Recruited Participants
Time Frame: 2 years
|
Number of participants enrolled into the study after screening and eligibility confirmation.
|
2 years
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Attended Last Study Visit
Time Frame: 3 months from randomization
|
Number of participants who completed the final study visit conducted approximately three months after randomization.
|
3 months from randomization
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Lama Ghazi, MD, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IRB-300012428
- P50MD017338 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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