NCT05186831

Brief Summary

The coronavirus disease 2019 (COVID-19) pandemic has uprooted conventional health care delivery for routine ambulatory care, requiring health systems to rapidly adopt telemedicine capabilities. The digital divide, has been well documented with lower rates of technology and broadband adoption among racial/ethnic minorities. Additionally, Black patients suffer a disproportionate burden of hypertension and cardiovascular disease. This study will implement a text-based home hypertension monitoring program among Black Medicaid patients with hypertension and cardiovascular disease (CVD) and compare its uptake to the currently available blood pressure monitoring program using the patient portal that is integrated into the electronic health record (EHR).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable hypertension

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

Study Start

First participant enrolled

October 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

December 21, 2021

Last Update Submit

January 10, 2022

Conditions

Keywords

Racial disparitiesDigital technologyHypertension

Outcome Measures

Primary Outcomes (2)

  • Number of BP measurements reported

    Number of BP results reported over the study period

    14 days

  • Proportion of patients submitting 1 or more BP measurement

    Proportion of patients per study arm reporting at least one BP measurement

    14 days

Secondary Outcomes (1)

  • Patient satisfaction

    Within 2 weeks of end of study period

Study Arms (2)

Text-based monitoring

EXPERIMENTAL

Patients will be asked to take their BP two times daily and text their BP to the study phone number twice a day for 14 days.

Behavioral: Texting

Online patient portal

ACTIVE COMPARATOR

Patients will be asked to take their BP two times daily. They will be given instructions on how to upload BP readings to the online patient portal and will be asked to upload all BP readings. This represents enhanced standard of care.

Behavioral: Online patient portal

Interventions

TextingBEHAVIORAL

Patients will be asked to text their BP. They will receive an automated response to their texts.

Text-based monitoring

Patients will be asked to upload their BP to the online patient portal. They will receive information on how to sign up and use the patient portal. Patients can upload their BP readings daily or at the end of the study period.

Online patient portal

Eligibility Criteria

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

You may qualify if:

  • Self-identified Black race
  • Medicaid or Medicare insurance
  • Hypertension
  • Cardiovascular disease or presence of at least 1 cardiovascular risk factor
  • Seen for in-person consultation at the Heart and Vascular clinic at the Hospital of the University of Pennsylvania

You may not qualify if:

  • Does not speak English
  • Already owns a BP cuff
  • Does not have internet access or a phone 15 with texting capabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

HypertensionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 11, 2022

Study Start

October 19, 2020

Primary Completion

December 29, 2020

Study Completion

January 14, 2021

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

Interested researchers can email study investigator to request de-identified participant data.

Shared Documents
STUDY PROTOCOL
Time Frame
Study data will be shared within a 4 week timeframe of request.
Access Criteria
Submission of a protocol describing analysis plan.

Locations