HypertensionNCT02898584
Utilizing Consumer Health Informatics to Support Management of Hypertension by Clinical Pharmacists in Primary Care
A study testing BP Track in people with Hypertension, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this research study is to test the feasibility, acceptability, and preliminary effectiveness of the use of a mobile pharmacist-led intervention that incorporates home BP monitoring and medication reminders with patients recruited from a primary care setting, as well as identify challenges and potential… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- BP Track
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a smart phone compatible with mobile intervention
- Have been previously diagnosed with hypertension
- Have uncontrolled hypertension (systolic blood pressure > 140 and/or diastolic blood pressure > 90 on repeat measurement)
- Be under the care of a primary care physician at the recruitment clinic
- Be taking at least one antihypertensive medication
- Be English speaking
Who cannot join
- Patients under the care of a clinical pharmacist for hypertension management, or under the care of a cardiologist
- Pregnant patients and anyone with the following unrelated, but serious medical conditions will also be excluded, as they may make blood pressure control difficult or necessitate frequent hospitalization: previous diagnosis of resistant hypertension; steroid dependent asthma or emphysema; cirrhosis or hepatic failure; stage C or D chronic heart failure; stage IV or V chronic kidney disease; and cancer (terminal or undergoing active chemotherapeutic or radiation therapy)
- Patients with other serious medical conditions (e.g., stroke, dementia) that may affect their ability to self-monitor blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to test the feasibility, acceptability, and preliminary effectiveness of the use of a mobile pharmacist-led intervention that incorporates home BP monitoring and medication reminders with patients recruited from a primary care setting, as well as identify challenges and potential solutions to broader implementation of a mobile pharmacist-led home-based BP monitoring intervention in primary care clinics through key stakeholder interviews.
- Conditions
- Hypertension
- Being tested
- BP Track
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP TrackOther
| Study group | Role | What they receive |
|---|---|---|
| BP Track | Other | The study participants will be asked to monitor their blood pressure twice daily at home for twelve weeks, and sync the data to the mobile intervention so that a clinical pharmacist can review and incorporate the data into ongoing hypertension management. Receives: Other: BP Track |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: from baseline to 12 weeks
Secondary outcomes (1)
Change in medication adherence as measured by the Adherence to Refills and Medications Scale (ARMS)
Measured: from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorraine Buis, University of Michigan
- Investigators
- Lorraine R Buis, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898584
- Sponsor's protocol ID
- MICHR T3-RIP
- Other IDs
- HUM00105772
- Status last verified
- Jul 2020
- First submitted
- 8 Sep 2016
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Buis LR, Roberson DN, Kadri R, Rockey NG, Plegue MA, Danak SU, Guetterman TC, Johnson MG, Choe HM, Richardson CR. Understanding the Feasibility, Acceptability, and Efficacy of a Clinical Pharmacist-led Mobile Approach (BPTrack) to Hypertension Management: Mixed Methods Pilot Study. J Med Internet Res. 2020 Aug 11;22(8):e19882. doi: 10.2196/19882.
PubMed 32780026Buis LR, Roberson DN, Kadri R, Rockey NG, Plegue MA, Choe HM, Richardson CR. Utilizing Consumer Health Informatics to Support Management of Hypertension by Clinical Pharmacists in Primary Care: Study Protocol. JMIR Res Protoc. 2017 Oct 10;6(10):e193. doi: 10.2196/resprot.8059.
PubMed 29017994
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Consumer Health Informatics to Support Management of Hypertension by Clinical Pharmacists in Primary Care
- ClinicalTrials.gov ID
- NCT02898584
- Acronym / sponsor ID
- MICHR T3-RIP
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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 test the feasibility, acceptability, and preliminary effectiveness of the use of a mobile pharmacist-led intervention that incorporates home BP monitoring and medication reminders with patients recruited from a primary care setting, as well as identify challenges and potential solutions to broader implementation of a mobile pharmacist-led home-based BP monitoring intervention in primary care clinics through key stakeholder interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BP Track | Other | Other: BP TrackThe study participants will be asked to monitor their blood pressure twice daily at home for twelve weeks, and sync the data to the mobile intervention so that a clinical pharmacist can review and incorporate the data into ongoing hypertension management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a smart phone compatible with mobile intervention
- Have been previously diagnosed with hypertension
- Have uncontrolled hypertension (systolic blood pressure > 140 and/or diastolic blood pressure > 90 on repeat measurement)
- Be under the care of a primary care physician at the recruitment clinic
- Be taking at least one antihypertensive medication
Key exclusion criteria (3 listed)
- Patients under the care of a clinical pharmacist for hypertension management, or under the care of a cardiologist
- Pregnant patients and anyone with the following unrelated, but serious medical conditions will also be excluded, as they may make blood pressure control difficult or necessitate frequent hospitalization: previous diagnosis of resistant hypertension; steroid dependent asthma or emphysema; cirrhosis or hepatic failure; stage C or D chronic heart failure; stage IV or V chronic kidney disease; and cancer (terminal or undergoing active chemotherapeutic or radiation therapy)
- Patients with other serious medical conditions (e.g., stroke, dementia) that may affect their ability to self-monitor blood pressure
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 |
|---|---|---|
| BP Track | Other | BP Track |
Primary outcome
Change in blood pressure
Time frame: from baseline to 12 weeks
1 secondary outcome
Change in medication adherence as measured by the Adherence to Refills and Medications Scale (ARMS)
Time frame: from baseline to 12 weeks
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 Jul 2020.
- Derived from this study: PubMed 32780026Buis LR, Roberson DN, Kadri R, Rockey NG, Plegue MA, Danak SU, Guetterman TC, Johnson MG, Choe HM, Richardson CR. Understanding the Feasibility, Acceptability, and Efficacy of a Clinical Pharmacist-led Mobile Approach (BPTrack) to Hypertension Management: Mixed Methods Pilot Study. J Med Internet Res. 2020 Aug 11;22(8):e19882. doi: 10.2196/19882.
- Derived from this study: PubMed 29017994Buis LR, Roberson DN, Kadri R, Rockey NG, Plegue MA, Choe HM, Richardson CR. Utilizing Consumer Health Informatics to Support Management of Hypertension by Clinical Pharmacists in Primary Care: Study Protocol. JMIR Res Protoc. 2017 Oct 10;6(10):e193. doi: 10.2196/resprot.8059.
- 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.
Lorraine R Buis, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BP Track in people with Hypertension, run by University of Michigan 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 6 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 14 Jul 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?
Change in blood pressure (time frame: from baseline to 12 weeks). 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 NCT02898584, which also lists 2 linked publications.
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 Jul 2020.