BP PAL - Hypertension Chat Bot Pilot

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: HTN Chat bot

Detailed 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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients assigned to intervention arm will a text message notifying them of enrollment, be mailed a BP cuff and receive a recruitment phone call if nonresponsive to text. If the patient does not opt out, the research coordinator will mail a blood pressure cuff and proper measurement instructions and start their remote monitoring program in the Way to Health platform. Intervention arm participants will also receive usual care. Usual care for hypertension is as needed determined by the clinical expertise of the primary care provider and can include regular follow-up visits (in person or virtual), home blood pressure readings, titration of medications during visits or via telephone, referral to specialty care (e.g., Nephrology or Cardiology), blood tests or imaging studies.	Behavioral: HTN Chat bot; Remote monitoring via automated messaging program
No Intervention: Control; Patients in the usual care arm will not be contacted by study staff at the start of the pilot, they will not receive a blood pressure cuff, and they will not receive any text messaging or any component of the program. They will eventually be contacted by study staff to schedule the 6 month BP check. Usual care for hypertension is as needed determined by the clinical expertise of the primary care provider and can include regular follow-up visits (in person or virtual), home blood pressure readings, titration of medications during visits or via telephone, referral to specialty care (e.g., Nephrology or Cardiology), blood tests or imaging studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	change in systolic blood pressure from baseline to 6 month visit	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure	comparison of diastolic blood pressure in the control arm and intervention arm at 6 month study visit	six months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Anna U Morgan, M.D., University of Pennsylvania; Principal Investigator: Eric Bressman, M.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: remote monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 852102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No