Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 DESIGN:
Pragmatic, non-blinded, randomized controlled trial.
Randomization and enrollment:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTN Chat bot | Behavioral | Remote monitoring via automated messaging program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | change in systolic blood pressure from baseline to 6 month visit | six months |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any patients meeting the following criteria are excluded from the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anna U Morgan, M.D. | University of Pennsylvania | Principal Investigator |
| Eric Bressman, M.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39633105 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided