SupportBP 2.0:Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management

University of Pennsylvania

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Opt-Out Recruitment; Behavioral: Opt-In Recruitment

Study type: Interventional

Funder types: Other

Identifiers

NCT04714398

844150

Details and patient eligibility

About

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).

Full 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.

Enrollment: 425 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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425 participants in 3 patient groups

Opt-In Recruitment

Experimental group

Description:

All recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program.

Treatment:

Behavioral: Opt-In Recruitment

Opt-Out

Experimental group

Description:

All recruitment messaging will be framed as though participation is the default, and patients must opt-out of participating in the remote monitoring program.

Treatment:

Behavioral: Opt-Out Recruitment

Usual Care

No Intervention group

Description:

Patients in the usual care arm will not be contacted by study staff, they will not receive a blood pressure cuff, and they will not be asked to participate in any component of the blood pressure monitoring program.