Clinical trial NCT04714398: SupportBP 2.0:Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management
Official title: SupportBP 2.0: Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: blood pressure
remote monitoring
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A 3-arm randomized pilot trial aimed at comparing the effectiveness of different approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (HTN).

Detailed description: The investigators will utilize the Way to Health (WTH) platform to develop and evaluate a new remote monitoring enrollment model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN the investigators will:

1. Compare the effect of sending eligible patients a blood pressure cuff with the mailed invitation letter and opt-out framing versus the more conventional method of phone calls following mailed letters.
2. Evaluate the feasibility and effectiveness of a remote monitoring program with individualized stepped escalation for hypertension management.

Eligibility criteria: Inclusion Criteria:

1. Between 18 and 75 years old with HTN (ICD-10 code I10)
2. Has had at least one office visit at Penn Family Care (PFC) within the past 12 months (at time of chart review), with the last visit having a BP reading exceeding HTN guidelines (150/90 if \>60 or, 140/90 if ages 21-59 yrs or has CKD or diabetes).
3. Must have a cellular phone with texting capabilities
4. Must be prescribed at least one medication for hypertension

Exclusion Criteria:

1. Has metastatic (Stage IV) cancer
2. Has end stage renal disease
3. Has congestive heart failure
4. Has dementia
5. BMI \>= 50
6. Is Non-English speaking requiring a translator

Primary outcomes:
measure: Proportion Participating by Recruitment Method
timeFrame: 6 months, from date of consent to end of remote monitoring program
Secondary outcomes:
measure: Proportion Engaged by Recruitment Method
timeFrame: 6 months, from date of consent to end of remote monitoring period
measure: Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care
timeFrame: 6 months, from date of consent to end of remote monitoring program
measure: Blood Pressure Trajectory by Recruitment Method
timeFrame: 6 months, from date of consent to end of remote monitoring program
measure: Proportion of BP Measurements Submitted by Recruitment Method
timeFrame: 6 months, from date of consent to end of remote monitoring program
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: