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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT05186831

Collaborator

(none)

Enrollment

Location

Arms

2.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hypertension Cardiovascular Diseases	Behavioral: Texting Behavioral: Online patient portal	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Oct 19, 2020

Actual Primary Completion Date :

Dec 29, 2020

Actual Study Completion Date :

Jan 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Text-based monitoring 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 Patients will be asked to text their BP. They will receive an automated response to their texts.
Active Comparator: Online patient portal 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 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.

Arm

Intervention/Treatment

Experimental: Text-based monitoring

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

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

Active Comparator: Online patient portal

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

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.

Outcome Measures

Primary Outcome Measures

Number of BP measurements reported [14 days]
Number of BP results reported over the study period
Proportion of patients submitting 1 or more BP measurement [14 days]
Proportion of patients per study arm reporting at least one BP measurement

Secondary Outcome Measures

Patient satisfaction [Within 2 weeks of end of study period]
Patients will be asked to complete a survey about ease of use and likelihood of recommending the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Lewey, MD, MPH, Assistant Professor of Medicine, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT05186831

Other Study ID Numbers:

University of Pennsylvania

First Posted:

Jan 11, 2022

Last Update Posted:

Jan 11, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jennifer Lewey, MD, MPH, Assistant Professor of Medicine, University of Pennsylvania

Racial disparities

Digital technology

Hypertension

Additional relevant MeSH terms:

Hypertension

Cardiovascular Diseases

Study Results

No Results Posted as of Jan 11, 2022