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Clinical Trial Summary

A 2-arm randomized pilot trial aimed at evaluating the effectiveness of a 6-month remote monitoring program for the management of hypertension (HTN). 300 eligible patients will be randomized in a 1:1 ratio into two recruitment arms: A) Control (usual care), or B) Remote monitoring via automated messaging program. The target population are patients at the Penn Family Medicine University City and Westtown primary care practices with baseline poor blood pressure control as indicated by two blood pressures greater than 140/90 within the past twelve month including the most recent measurement and on at least one anti-hypertensive agent.


Clinical Trial Description

STUDY DESIGN: Pragmatic, non-blinded, randomized controlled trial. Randomization and enrollment: - Randomization will be at the patient level (stratified/balanced randomization by PCP) - Enrollment will take place over short time period based off of lists of eligible patients pulled from the EMR - Lists of eligible patients sent to PCPs with opportunity to opt patients out. Patients will be contacted via text followed by phone call to introduce them to the program. We expect recruitment to take approximately 1 month to reach a target sample size of 300. The program itself will be 6 months from the date of randomization. Total study duration should be approximately 7 months. Data analyses will take an additional 3 months. The control group will receive usual care as determined by PCP (control arm will not receive BP cuffs).The Intervention Group will receive the BP cuff and weekly SMS messages asking for the BP reading. The methods section below will outline the details for both groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05571410
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase N/A
Start date January 9, 2023
Completion date October 31, 2023

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