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

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension
• Intervention / Treatment: Behavioral: Texting; Behavioral: Online patient portal

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patients will be asked to complete a survey about ease of use and likelihood of recommending the intervention	Within 2 weeks of end of study period

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): December 29, 2020
• Study Completion (Actual): January 14, 2021

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Digital technology; Racial disparities
• Additional Relevant MeSH Terms: Vascular Diseases; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: University of Pennsylvania

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No