NCT03416283

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2019

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

January 17, 2018

Last Update Submit

August 29, 2022

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    Systolic blood pressure during the 4-month study visit, adjusted for initial systolic blood pressure

    4 months

Secondary Outcomes (3)

  • Percent of patients that are normotensive

    4 months

  • Medication adherence

    4 months

  • Diastolic blood pressure

    4 months

Study Arms (3)

Remote Monitoring (RM)

EXPERIMENTAL

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

Behavioral: Remote Monitoring

Remote Monitoring + Social Support (RM+SS)

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Remote MonitoringBEHAVIORAL

Remote BP monitoring and medication adherence

Remote Monitoring (RM)
Remote Monitoring + Social SupportBEHAVIORAL

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

Remote Monitoring + Social Support (RM+SS)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Has metastatic (Stage IV) blood or solid tumor cancer
  • Has end stage renal disease
  • Has congestive heart failure
  • Has dementia
  • Has liver cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Mehta SJ, Volpp KG, Troxel AB, Teel J, Reitz CR, Purcell A, Shen H, McNelis K, Snider CK, Asch DA. Remote Blood Pressure Monitoring With Social Support for Patients With Hypertension: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2413515. doi: 10.1001/jamanetworkopen.2024.13515.

    PMID: 38829618DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Shivan Mehta, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single (Investigator)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 31, 2018

Study Start

May 20, 2018

Primary Completion

October 26, 2019

Study Completion

October 26, 2019

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)