HypertensionNCT04577131
Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support
A study testing Weekly check-in in people with Hypertension, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the impact of monitoring blood pressure from home everyday with pharmacist support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Weekly check-in
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 5 Nov 2020
- 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
- 18 years of age and older
- Uncontrolled hypertension (BP > 130/80 mm Hg)
Who cannot join
- non-English speaking patients
- patients without a mobile phone or texting capability
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
The purpose of this research study is to evaluate the impact of monitoring blood pressure from home everyday with pharmacist support.
Read the detailed description
High blood pressure is very common and increases risk of heart, kidney, brain, and eye disease. It is important to diagnose and treat high blood pressure to reduce risk of these complications. Getting blood pressure checked only when someone sees a doctor is not the best way to diagnose high blood pressure or to make sure blood pressure is well managed. Checking blood pressure at home gives a better idea of whether someone's blood pressure is normal or too high.
As part of their usual blood pressure monitoring, participants will be given an Omron 3 series or 5 series blood pressure monitor which has been cleared by the US Food and Drug Administration and validated to meet accuracy and performance requirements. For one month, participants will monitor their blood pressure once a day and then return the device to the clinic at the end of the study. Participants will text their blood pressure result to the American Heart Association's Check, Change, Control (CCC) secure online tracker.
As part of the research study, participants will also be randomized to either receive or not receive weekly check-in phone calls from a pharmacist to review their blood pressures and the number of times they tested in that week. Approximately 50 individuals will participate in this study. Participation in this study will last 1 month.
- Conditions
- Hypertension
- Being tested
- Weekly check-in
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly check-inBehavioural
Weekly check-in phone calls from a pharmacist to review blood pressures and the number of times tested in that week
| Study group | Role | What they receive |
|---|---|---|
| With check-ins | Experimental | Daily blood pressure monitoring with weekly check-ins Receives: Behavioral: Weekly check-in |
| Without check-ins | No intervention | Daily blood pressure monitoring without weekly check-ins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence to home blood pressure monitoring
Proportion of days blood pressure is measured based on data from the blood pressuring monitor
Measured: 1 month
Change in proportion of participants with a blood pressure <130/80 mm Hg.
Proportion of participants with a blood pressure <130/80 mm Hg.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start5 Nov 2020
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Why it stopped: The tracker application has been withdrawn by developer and no other suitable tracker application has been identified to replace it.
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 Virginia Commonwealth UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dave Dixon, PharmD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577131
- Sponsor's protocol ID
- HM20019041
- Status last verified
- Jan 2021
- First submitted
- 30 Sep 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Home Blood Pressure Monitoring With Pharmacist Support
- ClinicalTrials.gov ID
- NCT04577131
- Acronym / sponsor ID
- HM20019041
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The tracker application has been withdrawn by developer and no other suitable tracker application has been identified to replace it.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 6 Oct 2020 (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 purpose of this research study is to evaluate the impact of monitoring blood pressure from home everyday with pharmacist support.
Detailed description
High blood pressure is very common and increases risk of heart, kidney, brain, and eye disease. It is important to diagnose and treat high blood pressure to reduce risk of these complications. Getting blood pressure checked only when someone sees a doctor is not the best way to diagnose high blood pressure or to make sure blood pressure is well managed. Checking blood pressure at home gives a better idea of whether someone's blood pressure is normal or too high.
As part of their usual blood pressure monitoring, participants will be given an Omron 3 series or 5 series blood pressure monitor which has been cleared by the US Food and Drug Administration and validated to meet accuracy and performance requirements. For one month, participants will monitor their blood pressure once a day and then return the device to the clinic at the end of the study. Participants will text their blood pressure result to the American Heart Association's Check, Change, Control (CCC) secure online tracker.
As part of the research study, participants will also be randomized to either receive or not receive weekly check-in phone calls from a pharmacist to review their blood pressures and the number of times they tested in that week. Approximately 50 individuals will participate in this study. Participation in this study will last 1 month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With check-ins | Experimental | Behavioral: Weekly check-inDaily blood pressure monitoring with weekly check-ins |
| Without check-ins | No intervention | –Daily blood pressure monitoring without weekly check-ins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age and older
- Uncontrolled hypertension (BP > 130/80 mm Hg)
Key exclusion criteria (2 listed)
- non-English speaking patients
- patients without a mobile phone or texting capability
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 |
|---|---|---|
| Weekly check-inWeekly check-in phone calls from a pharmacist to review blood pressures and the number of times tested in that week | Behavioural | With check-ins |
Primary outcome
Change in adherence to home blood pressure monitoring
Time frame: 1 month
Proportion of days blood pressure is measured based on data from the blood pressuring monitor
Change in proportion of participants with a blood pressure <130/80 mm Hg.
Time frame: 1 month
Proportion of participants with a blood pressure <130/80 mm Hg.
Results and safety
The study was stopped early (reason given: The tracker application has been withdrawn by developer and no other suitable tracker application has been identified to replace it.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Dave Dixon, PharmD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly check-in in people with Hypertension, run by Virginia Commonwealth University 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Jan 2021. 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 was stopped early (reason given: The tracker application has been withdrawn by developer and no other suitable tracker application has been identified to replace it.). Results are not available in the source record.
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?
Change in adherence to home blood pressure monitoring (time frame: 1 month). 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 15 Jan 2021.