Remote Monitoring and Social Support for Hypertension Management

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Remote Monitoring; Behavioral: Remote Monitoring + Social Support

• Registration Number: NCT03416283
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-31
• Study Start: 2018-05-20
• Primary Completion: 2019-10-26
• Study Completion: 2019-10-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Monitoring (RM)	Remote Monitoring	Remote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence.
Remote Monitoring + Social Support (RM+SS)	Remote Monitoring + Social Support	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.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	4 months	Systolic blood pressure during the 4-month study visit, adjusted for initial systolic blood pressure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States