HypertensionBP FirstNCT04275934
Blood Pressure First Medication Therapy Management
An observational study of Hypertension and Blood Pressure, run by American Pharmacists Association Foundation at 1 site in United States.
Trial summary
The primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure, Cardiovascular Diseases
- What is being tested?
- Health Management; Blood Pressure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 31 Dec 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Beneficiaries of self-insured employer who may benefit from patient-centered, team-based care that supports blood pressure control.
Who may be able to join
- All health plan beneficiaries 18 years-of-age and older
- Have filled at least one blood pressure medication in the last three months,
- Have a known hypertension diagnosis or have an uncontrolled blood pressure
Who cannot join
- Not an adult
- Not a health plan beneficiary of the self-insured employer
- Not ambulatory and able to work or participate in care visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Woodstock Pharmaceutical & Compounding Center Inc.
Woodstock, Georgia, 30188
About this study
Official title: Evaluation of the Impact of Self-insured Employer Implementation of an Innovative Care Model Utilizing Pharmacist-delivered MTM Services for Health Plan Beneficiaries With High Blood Pressure
The primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.
Read the detailed description
Univariate comparisons of the baseline/pre-intervention outcomes to the post-intervention outcomes will be performed on outcomes in order to determine how the intervention affects each. For continuous outcomes data the univariate comparisons of the pre-treatment and post-intervention outcomes will be performed using related samples t-test comparisons. For categorical outcomes data, comparisons of pre-intervention to post-intervention time frames will be performed using McNemar tests.
- Conditions
- Hypertension, Blood Pressure, Cardiovascular Diseases
- Being tested
- Health Management; Blood Pressure
- 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.
Health Management; Blood PressureBehavioural
Pharmacists will work with the patient/study subject, referred to as the participant hereafter, and the participant's other health care providers to manage their blood pressure, making recommendations for medication and lifestyle adjustments as needed.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | This project will evaluate the impact of self-insured employers implementing an innovative care model utilizing pharmacist-delivered MTM services for health plan beneficiaries with high blood pressure. Receives: Behavioral: Health Management; Blood Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Control
Management of Systolic and Diastolic Blood Pressure Measures
Measured: 6-months
Blood Pressure Change
Systolic and Diastolic Blood Pressure Measure Changes
Measured: 6-months
Secondary outcomes (4)
Blood Pressure Medication Adherence
Medication Adherence for Blood Pressure Medications as Measured by Proportion of Days Covered (PDC)
Measured: 6-months
Health Care Utilization of Primary Care Services
Evaluation of Pre- and Post-Intervention Frequency of Primary Health Care Visits
Measured: 6-months
Health Care Utilization of Emergency Department Services
Evaluation of Pre- and Post-Intervention Frequency Emergency Department Visits
Measured: 6-months
Health Care Utilization of Hospital Services
Evaluation of Pre- and Post-Intervention Frequency of Hospital Visits
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 posted19 Feb 2020
- Study start6 Feb 2020
- Primary completion31 Jul 2020
- Study completion31 Dec 2020
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Pharmacists Association Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin M Bluml, RPh, Principal investigator, APhA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275934
- Sponsor's protocol ID
- 020
- Acronym
- BP First
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Self-insured Employer Implementation of an Innovative Care Model Utilizing Pharmacist-delivered MTM Services for Health Plan Beneficiaries With High Blood Pressure
- ClinicalTrials.gov ID
- NCT04275934
- Acronym / sponsor ID
- BP First / 020
- Conditions
- Hypertension, Blood Pressure, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- American Pharmacists Association FoundationUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Feb 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 primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.
Detailed description
Univariate comparisons of the baseline/pre-intervention outcomes to the post-intervention outcomes will be performed on outcomes in order to determine how the intervention affects each. For continuous outcomes data the univariate comparisons of the pre-treatment and post-intervention outcomes will be performed using related samples t-test comparisons. For categorical outcomes data, comparisons of pre-intervention to post-intervention time frames will be performed using McNemar tests.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Behavioral: Health Management; Blood PressureThis project will evaluate the impact of self-insured employers implementing an innovative care model utilizing pharmacist-delivered MTM services for health plan beneficiaries with high blood pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Beneficiaries of self-insured employer who may benefit from patient-centered, team-based care that supports blood pressure control.
Key inclusion criteria (3 listed)
- All health plan beneficiaries 18 years-of-age and older
- Have filled at least one blood pressure medication in the last three months,
- Have a known hypertension diagnosis or have an uncontrolled blood pressure
Key exclusion criteria (3 listed)
- Not an adult
- Not a health plan beneficiary of the self-insured employer
- Not ambulatory and able to work or participate in care visits
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 |
|---|---|---|
| Health Management; Blood PressurePharmacists will work with the patient/study subject, referred to as the participant hereafter, and the participant's other health care providers to manage their blood pressure, making recommendations for medication and lifestyle adjustments as needed. | Behavioural | Cohort |
Primary outcome
Blood Pressure Control
Time frame: 6-months
Management of Systolic and Diastolic Blood Pressure Measures
Blood Pressure Change
Time frame: 6-months
Systolic and Diastolic Blood Pressure Measure Changes
4 secondary outcomes
Blood Pressure Medication Adherence
Time frame: 6-months
Health Care Utilization of Primary Care Services
Time frame: 6-months
Health Care Utilization of Emergency Department Services
Time frame: 6-months
Health Care Utilization of Hospital Services
Time frame: 6-months
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 21 Feb 2023.
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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 M Bluml, RPh principal investigator
APhA Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Blood Pressure, run by American Pharmacists Association Foundation 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 3 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 21 Feb 2023. 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?
Blood Pressure Control (time frame: 6-months). 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 21 Feb 2023.