CompletedNCT03416283SupportBPUpdated Aug 31, 2022

Remote Monitoring and Social Support for Hypertension Management

An interventional study of Remote Monitoring and Remote Monitoring + Social Support in Hypertension, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-31.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 250
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

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

Read the 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:

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.

Conditions studied

Hypertension

Browse trials for

Hypertension 6,678

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 250 participants (actual)

Study arms

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
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
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.

Interventions

BehavioralRemote Monitoring
Remote BP monitoring and medication adherence
BehavioralRemote Monitoring + Social Support
Remote BP monitoring and medication adherence with enhanced support from a support partner ("facilitated cheerleading")

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03416283
Lead sponsor: University of Pennsylvania
Responsible party: Sponsor
First posted: Jan 31, 2018
Start date: May 20, 2018
Primary completion: Oct 26, 2019
Completion: Oct 26, 2019
Last update: Aug 31, 2022

Study contacts

Shivan Mehta, MD

principal investigator · University of Pennsylvania

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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