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BP PAL - Hypertension Chat Bot Pilot

Primary Purpose

Hypertension

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HTN Chat bot
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring remote monitoring

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Systolic Blood Pressure
change in systolic blood pressure from baseline to 6 month visit

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2022
Last Updated
August 29, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05571410
Brief Title
BP PAL - Hypertension Chat Bot Pilot
Official Title
Program Design Hypertension Chat Bot Pilot Study With the Primary Care Service Line
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
remote monitoring

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HTN Chat bot
Intervention Description
Remote monitoring via automated messaging program
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
change in systolic blood pressure from baseline to 6 month visit
Time Frame
six months
Secondary Outcome Measure Information:
Title
Diastolic Blood Pressure
Description
comparison of diastolic blood pressure in the control arm and intervention arm at 6 month study visit
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna U Morgan, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Bressman, M.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

BP PAL - Hypertension Chat Bot Pilot

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