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Completed

NCT Number: NCT04714398

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

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).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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:

  • 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.
  • Evaluate the feasibility and effectiveness of a remote monitoring program with individualized stepped escalation for hypertension management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 and 75 years old with HTN (ICD-10 code I10)
  • 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).
  • Must have a cellular phone with texting capabilities
  • Must be prescribed at least one medication for hypertension

Exclusion criteria

  • Has metastatic (Stage IV) cancer
  • Has end stage renal disease
  • Has congestive heart failure
  • Has dementia
  • BMI >= 50
  • Is Non-English speaking requiring a translator

Treatment and study plan

Opt-In Recruitment

Behavioral

Patients in the opt-in recruitment arm will receive a letter describing the program and inviting them to participate in the remote monitoring program. Along with the letter they will receive an informational brochure and a copy of the informed consent form. Patients in this arm will then receive a recruitment phone call explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will mail a blood pressure cuff and begin the remote monitoring program for the patient 6 days later.

Opt-Out Recruitment

Behavioral

Patients assigned to opt-out recruitment will receive a blood pressure cuff with instructions in the mail along with a letter describing the program and opt-out framing regarding their participation, as well as a brochure and a copy of the informed consent form. Patients in this arm will receive a recruitment phone call similar to recruitment arm A, explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will begin the remote monitoring program for the patient immediately.

Primary outcomes

  1. Proportion Participating by Recruitment Method

    Time frame: 6 months, from date of consent to end of remote monitoring program

    The proportion of patients participating in each study arm out of the number randomized to that study arm.

Secondary outcomes

  1. Proportion Engaged by Recruitment Method

    Time frame: 6 months, from date of consent to end of remote monitoring period

    The proportion of patients recruited by each method who are actively engaged with the program

  2. Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care

    Time frame: 6 months, from date of consent to end of remote monitoring program

    The proportion with controlled blood pressure by remote monitoring and the proportion with controlled blood pressure by clinic visits (usual care).

  3. Blood Pressure Trajectory by Recruitment Method

    Time frame: 6 months, from date of consent to end of remote monitoring program

    The systolic and diastolic blood pressure trajectory by recruitment arm.

  4. Proportion of BP Measurements Submitted by Recruitment Method

    Time frame: 6 months, from date of consent to end of remote monitoring program

    The proportion of requested BP measurements submitted by each patient by recruitment arm

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2021
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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