BP PAL - Hypertension Chat Bot Pilot

NCT05571410 | Completed

• 1 other identifier: 852102
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

remote monitoring

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  change in systolic blood pressure from baseline to 6 month visit

  six months

Secondary Outcomes (1)

• Diastolic Blood Pressure

  six months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

HTN Chat bot BEHAVIORAL

Remote monitoring via automated messaging program

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Bressman E, Profka K, Norton L, Clark K, Mahraj K, Walker Z, Reid-Bey L, Girard A, Rareshide C, Xu L, Zhu J, Putt M, Volpp KG, Morgan AU. Automated Text Message-Based Program to Improve Uncontrolled Blood Pressure in Primary Care Patients: A Randomized Clinical Trial. J Gen Intern Med. 2025 May;40(6):1248-1254. doi: 10.1007/s11606-024-09225-4. Epub 2024 Dec 4.

  PMID: 39633105 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anna U Morgan, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Eric Bressman, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: January 9, 2023
• Primary Completion: August 31, 2023
• Study Completion: October 31, 2023
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)