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OpenTrials
Completed

NCT Number: NCT05571410

BP PAL - Hypertension Chat Bot Pilot

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) Two blood pressures > 140/90 within the past 12 months, including the most recent measurement AND 2) On at least one anti-hypertensive agent AND 3) On HTN registry AND 4)On PCSL registry 5) Are active patients at the Penn Family Medicine University City, Penn Presby and Westtown practices

Exclusion criteria

  • Any patients meeting the following criteria are excluded from the study:
  • On a PCSK9 inhibitor medication
  • Pregnant or currently breastfeeding
  • Have a significant disability or markedly shortened life expectancy (metastatic cancer, on hospice, ESRD, dementia, end stage renal failure, congestive heart failure)
  • Not fluent in English

Treatment and study plan

HTN Chat bot

Behavioral

Remote monitoring via automated messaging program

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: six months

    change in systolic blood pressure from baseline to 6 month visit

Secondary outcomes

  1. Diastolic Blood Pressure

    Time frame: six months

    comparison of diastolic blood pressure in the control arm and intervention arm at 6 month study visit

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Program Design Hypertension Chat Bot Pilot Study With the Primary Care Service Line

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 7, 2022
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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