HypertensionNCT03920956
24-Hour Ambulatory Blood Pressure Monitoring in Community Pharmacies
A study testing ABPM service by Pharmacists in people with Hypertension, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study is designed to explore the feasibility of providing 24-hour ambulatory blood pressure monitoring in community pharmacies. The investigators hypothesize it will be feasible for community pharmacies to provide the service to assist medical providers in the diagnosing and management of high blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- ABPM service by Pharmacists
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2019to 24 Jan 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
- Adults greater than or equal to 18 years of age suspected by their physician of having "white coat" or "masked" hypertension (HTN), hypotension symptoms due to antihypertensive therapy, uncontrolled sustained HTN, requiring additional confirmation of an initial diagnosis if HTN, or resistant HTN.
Who cannot join
- Documented past medical history of persistent atrial fibrillation, on hemodialysis, pregnancy, or dementia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23236
About this study
Official title: Implementation & Evaluation of a 24-Hour Ambulatory Blood Pressure Monitoring Service in Community Pharmacies
This study is designed to explore the feasibility of providing 24-hour ambulatory blood pressure monitoring in community pharmacies. The investigators hypothesize it will be feasible for community pharmacies to provide the service to assist medical providers in the diagnosing and management of high blood pressure. The investigators will also survey participants regarding their experience with the service as well as conduct interviews with participating pharmacists and medical providers to understand their views and opinions on the feasibility of the service.
- Conditions
- Hypertension
- Being tested
- ABPM service by Pharmacists
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABPM service by PharmacistsOther
Patients will receive ABPM services provided by a pharmacist and complete a patient satisfaction survey
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 24-hour ABPM by Pharmacists | Experimental | Patients will meet with the pharmacist to be equipped with a 24-hour ambulatory blood pressure monitor (ABPM). Patients will return the monitor for the pharmacists to download the results to send to their medical provider. Receives: Other: ABPM service by Pharmacists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with the pharmacy service and experience wearing the ABPM
Patient satisfaction will be assessed using a 9 item survey. Participants will rate items on a 5-point scale from strongly agree to strongly disagree.
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start24 Jul 2019
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 53 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
- NCT03920956
- Sponsor's protocol ID
- HM20015789
- Status last verified
- Feb 2020
- First submitted
- 16 Apr 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khaddage SJ, Patterson JA, Sargent LJ, Price ET, Dixon DL. Sex and Age Differences in Ambulatory Blood Pressure Monitoring Tolerability. Am J Hypertens. 2021 Apr 20;34(4):335-338. doi: 10.1093/ajh/hpaa182.
PubMed 33180905
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation & Evaluation of a 24-Hour Ambulatory Blood Pressure Monitoring Service in Community Pharmacies
- ClinicalTrials.gov ID
- NCT03920956
- Acronym / sponsor ID
- HM20015789
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 19 Apr 2019 (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 the feasibility of providing 24-hour ambulatory blood pressure monitoring in community pharmacies. The investigators hypothesize it will be feasible for community pharmacies to provide the service to assist medical providers in the diagnosing and management of high blood pressure. The investigators will also survey participants regarding their experience with the service as well as conduct interviews with participating pharmacists and medical providers to understand their views and opinions on the feasibility of the service.
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 |
|---|---|---|
| Experimental: 24-hour ABPM by Pharmacists | Experimental | Other: ABPM service by PharmacistsPatients will meet with the pharmacist to be equipped with a 24-hour ambulatory blood pressure monitor (ABPM). Patients will return the monitor for the pharmacists to download the results to send to their medical provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults greater than or equal to 18 years of age suspected by their physician of having "white coat" or "masked" hypertension (HTN), hypotension symptoms due to antihypertensive therapy, uncontrolled sustained HTN, requiring additional confirmation of an initial diagnosis if HTN, or resistant HTN.
Key exclusion criteria (1 listed)
- Documented past medical history of persistent atrial fibrillation, on hemodialysis, pregnancy, or dementia.
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 |
|---|---|---|
| ABPM service by PharmacistsPatients will receive ABPM services provided by a pharmacist and complete a patient satisfaction survey | Other | Experimental: 24-hour ABPM by Pharmacists |
Primary outcome
Patient satisfaction with the pharmacy service and experience wearing the ABPM
Time frame: up to 72 hours
Patient satisfaction will be assessed using a 9 item survey. Participants will rate items on a 5-point scale from strongly agree to strongly disagree.
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 5 Feb 2020.
- Derived from this study: PubMed 33180905Khaddage SJ, Patterson JA, Sargent LJ, Price ET, Dixon DL. Sex and Age Differences in Ambulatory Blood Pressure Monitoring Tolerability. Am J Hypertens. 2021 Apr 20;34(4):335-338. doi: 10.1093/ajh/hpaa182.
- 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 ABPM service by Pharmacists 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 1 inclusion and 1 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 5 Feb 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?
Patient satisfaction with the pharmacy service and experience wearing the ABPM (time frame: up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03920956, which also lists 1 linked publication.
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 5 Feb 2020.