Remote Monitoring and Social Support for Hypertension Management (SupportBP)

Remote Monitoring and Enhanced Social Support for Hypertension Management

A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote approaches to improving blood pressure (BP) control.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Remote Monitoring; Behavioral: Remote Monitoring + Social Support

Detailed Description

The investigators plan to leverage the Way to Health (WTH) platform to develop and evaluate a new HTN service-delivery 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:

1. The investigators will assess the effects of monitoring blood pressure and medication adherence with feedback to the patient and to the clinical practice, as needed if out of control.
2. The investigators will also compare the impact of providing feedback to a social support partner with facilitated cheerleading.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between 18 and 75 years old with HTN (ICD-10 code I10)
• Has had at least two office visits at Penn Family Care (PFC) within the past 12 months (at time of chart review), with at least two of the visits with BP readings exceeding HTN guidelines, including the last visit (150/90 or 140/90 if ages 21-59 yrs with 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) blood or solid tumor cancer
• Has end stage renal disease
• Has congestive heart failure
• Has dementia
• Has liver cirrhosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Remote Monitoring (RM); Remote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence.	Behavioral: Remote Monitoring; Remote BP monitoring and medication adherence
EXPERIMENTAL: Remote Monitoring + Social Support (RM+SS); Remote Monitoring + Social Support subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence, as well as a social support partner to provide additional feedback to the participant on their monitoring and adherence practices.	Behavioral: Remote Monitoring + Social Support; Remote BP monitoring and medication adherence with enhanced support from a support partner ("facilitated cheerleading")
NO_INTERVENTION: Usual Care; Usual care subjects will not receive a blood pressure cuff or bidirectional text messaging. They will be asked to take their medication and monitor BP as usual with no additional contact from study staff until the 4 month study follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Systolic blood pressure during the 4-month study visit, adjusted for initial systolic blood pressure	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients that are normotensive	The percent of patients with final blood pressure within the normal range.	4 months
Medication adherence	Medication adherence as measured by the text message response	4 months
Diastolic blood pressure	Adjusted for initial diastolic blood pressure	4 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2018
• Primary Completion (ACTUAL): October 26, 2019
• Study Completion (ACTUAL): October 26, 2019

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (ACTUAL): January 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 828417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No