Remote Monitoring and Social Support for Hypertension Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-20

Study Completion Date

2019-10-26

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.

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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:

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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Single (Investigator)

Study Groups

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Remote Monitoring (RM)

Remote Monitoring subjects will receive a blood pressure cuff and bidirectional text messaging regarding blood pressure and medication adherence.

Group Type EXPERIMENTAL

Remote Monitoring

Intervention Type BEHAVIORAL

Remote BP monitoring and medication adherence

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.

Group Type EXPERIMENTAL

Remote Monitoring + Social Support

Intervention Type BEHAVIORAL

Remote BP monitoring and medication adherence with enhanced support from a support partner ("facilitated cheerleading")

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote Monitoring

Remote BP monitoring and medication adherence

Intervention Type BEHAVIORAL

Remote Monitoring + Social Support

Remote BP monitoring and medication adherence with enhanced support from a support partner ("facilitated cheerleading")

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No