BP PAL - Hypertension Chat Bot Pilot

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05571410
• Other study ID #: 852102
• Status: Completed
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• HTN Chat bot
Remote monitoring via automated messaging program

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	change in systolic blood pressure from baseline to 6 month visit	six months
Secondary	Diastolic Blood Pressure	comparison of diastolic blood pressure in the control arm and intervention arm at 6 month study visit	six months