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BP PAL - Hypertension Chat Bot Pilot

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05571410
Enrollment
300
Registered
2022-10-07
Start date
2023-01-09
Completion date
2023-10-31
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

remote monitoring

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.

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.

Interventions

BEHAVIORALHTN Chat bot

Remote monitoring via automated messaging program

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic Blood Pressuresix monthschange in systolic blood pressure from baseline to 6 month visit

Secondary

MeasureTime frameDescription
Diastolic Blood Pressuresix monthscomparison of diastolic blood pressure in the control arm and intervention arm at 6 month study visit

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026