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Patient-Portal vs Text-based Hypertension Monitoring Among Black Medicaid/Medicare Patients

Primary Purpose

Hypertension, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Texting
Online patient portal
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Racial disparities, Digital technology, Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Text-based monitoring

Online patient portal

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of BP measurements reported
Number of BP results reported over the study period
Proportion of patients submitting 1 or more BP measurement
Proportion of patients per study arm reporting at least one BP measurement

Secondary Outcome Measures

Patient satisfaction
Patients will be asked to complete a survey about ease of use and likelihood of recommending the intervention

Full Information

First Posted
December 21, 2021
Last Updated
January 10, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05186831
Brief Title
Patient-Portal vs Text-based Hypertension Monitoring Among Black Medicaid/Medicare Patients
Official Title
Patient-Portal vs Text-based Hypertension Monitoring Among Black Medicaid/Medicare Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
December 29, 2020 (Actual)
Study Completion Date
January 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Diseases
Keywords
Racial disparities, Digital technology, Hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text-based monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
Online patient portal
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Texting
Intervention Description
Patients will be asked to text their BP. They will receive an automated response to their texts.
Intervention Type
Behavioral
Intervention Name(s)
Online patient portal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of BP measurements reported
Description
Number of BP results reported over the study period
Time Frame
14 days
Title
Proportion of patients submitting 1 or more BP measurement
Description
Proportion of patients per study arm reporting at least one BP measurement
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Patients will be asked to complete a survey about ease of use and likelihood of recommending the intervention
Time Frame
Within 2 weeks of end of study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Does not speak English Already owns a BP cuff Does not have internet access or a phone 15 with texting capabilities
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Interested researchers can email study investigator to request de-identified participant data.
IPD Sharing Time Frame
Study data will be shared within a 4 week timeframe of request.
IPD Sharing Access Criteria
Submission of a protocol describing analysis plan.

Learn more about this trial

Patient-Portal vs Text-based Hypertension Monitoring Among Black Medicaid/Medicare Patients

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