HypertensionNCT03323840
Pilot for a Community Pharmacy Service Model: Impact of a Pharmacist Monitored Patient Blood Pressure Readings
A study testing Incentivized Care in people with Hypertension, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study is designed to explore whether routine measurement of blood pressure by community pharmacists can improve patient adherence to blood pressure medications. The study will utilize an incentivized care approach, in which patients receive a $10 gift card for every time they come to the pharmacy for blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Incentivized Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2018to 26 Nov 2019
- 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
- Age ≥18 years
- Diagnosis of hypertension
- Current prescription for ≥2 antihypertensive medications for primary diagnosis of hypertension
- Prior use of ≥1 antihypertensive medication for ≥6 months at the same Kroger's Pharmacy (#523)
- Willing and able to provide written informed consent
Who cannot join
- Age <18 years
- New diagnosis of hypertension within the prior 6 months
- Current pregnancy or lactation
- Limited English Proficiency
- Use of antihypertensive medications for secondary prevention of cardiovascular events. Patients with history of acute myocardial infarction, stroke, heart failure will be excluded, however, patients with diabetes will be eligible for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
This study is designed to explore whether routine measurement of blood pressure by community pharmacists can improve patient adherence to blood pressure medications. The study will utilize an incentivized care approach, in which patients receive a $10 gift card for every time they come to the pharmacy for blood pressure management (up to 2 times/month). The investigators hypothesize that the simple process of coming in for a blood pressure measurement (without any other scripted interventions, counseling, or consultation) will be feasible and sufficient to improve adherence to medications. The investigators will also collect preliminary data to help estimate how these hypothetical improvements in adherence might result in improved blood pressure control, fewer office visits, and (ultimately) fewer adverse cardiovascular outcomes (i.e. heart attacks, strokes, etc).
- Conditions
- Hypertension
- Being tested
- Incentivized Care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentivized CareOther
Patients will receive a $10 gift card for every blood pressure measurement (up to 2 times/month)
| Study group | Role | What they receive |
|---|---|---|
| Incentivized Care | Experimental | Patients will meet with the pharmacist up to 2 times/month for blood pressure measurement. Patients will receive a $10 gift card for each measurement. Receives: Other: Incentivized Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Percentage of blood pressure measurements completed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start15 Jan 2018
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Van Tassell, PharmD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323840
- Sponsor's protocol ID
- HM20011451
- Status last verified
- Aug 2020
- First submitted
- 24 Oct 2017
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- 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 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot for a Community Pharmacy Service Model: Impact of a Pharmacist Monitored Patient Blood Pressure Readings
- ClinicalTrials.gov ID
- NCT03323840
- Acronym / sponsor ID
- HM20011451
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 27 Oct 2017 (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.
This study is designed to explore whether routine measurement of blood pressure by community pharmacists can improve patient adherence to blood pressure medications. The study will utilize an incentivized care approach, in which patients receive a $10 gift card for every time they come to the pharmacy for blood pressure management (up to 2 times/month). The investigators hypothesize that the simple process of coming in for a blood pressure measurement (without any other scripted interventions, counseling, or consultation) will be feasible and sufficient to improve adherence to medications. The investigators will also collect preliminary data to help estimate how these hypothetical improvements in adherence might result in improved blood pressure control, fewer office visits, and (ultimately) fewer adverse cardiovascular outcomes (i.e. heart attacks, strokes, etc).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incentivized Care | Experimental | Other: Incentivized CarePatients will meet with the pharmacist up to 2 times/month for blood pressure measurement. Patients will receive a $10 gift card for each measurement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosis of hypertension
- Current prescription for ≥2 antihypertensive medications for primary diagnosis of hypertension
- Prior use of ≥1 antihypertensive medication for ≥6 months at the same Kroger's Pharmacy (#523)
- Willing and able to provide written informed consent
Key exclusion criteria (5 listed)
- Age <18 years
- New diagnosis of hypertension within the prior 6 months
- Current pregnancy or lactation
- Limited English Proficiency
- Use of antihypertensive medications for secondary prevention of cardiovascular events. Patients with history of acute myocardial infarction, stroke, heart failure will be excluded, however, patients with diabetes will be eligible for participation.
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 |
|---|---|---|
| Incentivized CarePatients will receive a $10 gift card for every blood pressure measurement (up to 2 times/month) | Other | Incentivized Care |
Primary outcome
Feasibility
Time frame: 6 months
Percentage of blood pressure measurements completed
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 14 Aug 2020.
- 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.
Benjamin Van Tassell, 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 Incentivized Care 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 5 inclusion and 5 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 14 Aug 2020. 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?
Feasibility (time frame: 6 months). 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 14 Aug 2020.