Remote Monitoring and Social Support for Hypertension Management

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

Detailed Description
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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: 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. The investigators will also compare the impact of providing feedback to a social support partner with facilitated cheerleading.

Official Title
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Remote Monitoring and Enhanced Social Support for Hypertension Management

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Remote Monitoring
* Behavioral: Remote Monitoring + Social Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Monitoring (RM)<br>Remote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence. | Behavioral: Remote Monitoring<br>* Remote BP monitoring and medication adherence<br>|
| Experimental: Remote Monitoring + Social Support (RM+SS)<br>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<br>* Remote BP monitoring and medication adherence with enhanced support from a support partner (facilitated cheerleading)<br>|
| No Intervention: Usual Care<br>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?
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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 |