HypertensionNCT05186831
Patient-Portal vs Text-based Hypertension Monitoring Among Black Medicaid/Medicare Patients
A study testing Texting and Online patient portal in people with Hypertension and Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Cardiovascular Diseases
- What is being tested?
- Texting and Online patient portal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 14 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not speak English
- Already owns a BP cuff
- Does not have internet access or a phone 15 with texting capabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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).
- Conditions
- Hypertension, Cardiovascular Diseases
- Being tested
- Texting, Online patient portal
- Keywords
- Racial disparities, Digital technology, Hypertension
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TextingBehavioural
Patients will be asked to text their BP. They will receive an automated response to their texts.
Online patient portalBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Online patient portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of BP measurements reported
Number of BP results reported over the study period
Measured: 14 days
Proportion of patients submitting 1 or more BP measurement
Proportion of patients per study arm reporting at least one BP measurement
Measured: 14 days
Secondary outcomes (1)
Patient satisfaction
Patients will be asked to complete a survey about ease of use and likelihood of recommending the intervention
Measured: Within 2 weeks of end of study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start19 Oct 2020
- Primary completion29 Dec 2020
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Lewey, MD, MPH, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186831
- Sponsor's protocol ID
- University of Pennsylvania
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Interested researchers can email study investigator to request de-identified participant data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Portal vs Text-based Hypertension Monitoring Among Black Medicaid/Medicare Patients
- ClinicalTrials.gov ID
- NCT05186831
- Acronym / sponsor ID
- University of Pennsylvania
- Conditions
- Hypertension, Cardiovascular Diseases
- Keywords
- Racial disparities, Digital technology, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text-based monitoring | Experimental | Behavioral: TextingPatients 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. |
| Online patient portal | Active comparator | Behavioral: Online patient portalPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Does not speak English
- Already owns a BP cuff
- Does not have internet access or a phone 15 with texting capabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TextingPatients will be asked to text their BP. They will receive an automated response to their texts. | Behavioural | Text-based monitoring |
| Online patient portalPatients 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. | Behavioural | Online patient portal |
Primary outcome
Number of BP measurements reported
Time frame: 14 days
Number of BP results reported over the study period
Proportion of patients submitting 1 or more BP measurement
Time frame: 14 days
Proportion of patients per study arm reporting at least one BP measurement
1 secondary outcome
Patient satisfaction
Time frame: Within 2 weeks of end of study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Yes. Interested researchers can email study investigator to request de-identified participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Texting and Online patient portal in people with Hypertension and Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of BP measurements reported (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.