HypertensionNCT03291535
Virtual Hypertension Management Pilot
A study testing Connected-device in people with Hypertension and Electronic Health Record, run by Stanford University at 2 sites in United States.
Trial summary
Investigators are examining the quality improvement impact of providing patients with a an electronic health record-connected blood pressure cuff. Investigators will give half of patients already eligible for hypertension management within a clinical pharmacist panel, the ability to upload their blood pressure data… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Electronic Health Record, Digital Health
- What is being tested?
- Connected-device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jul 2017to 1 Mar 2022
- 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
- Hypertension as defined by clinical pharmacist usual care panel (2 or more readings of blood pressure >140/90)
Who cannot join
- Pregnancy
- Chronic kidney disease III or IV
- Systolic heart failure with ejection fraction <35%
- Current use of 3 or more anti-hypertension drugs
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford Primary Care
Portola Valley, California, 94028
Stanford Primary Care Clinic
Santa Clara, California, 95054
About this study
Official title: Virtual Hypertension Management Pilot: Randomized Evaluation of Electronic Health Record-connected Blood Pressure Cuffs in a Clinical Pharmacist Panel.
Investigators are examining the quality improvement impact of providing patients with a an electronic health record-connected blood pressure cuff. Investigators will give half of patients already eligible for hypertension management within a clinical pharmacist panel, the ability to upload their blood pressure data into Stanford's electronic health record.
- Conditions
- Hypertension, Electronic Health Record, Digital Health
- Being tested
- Connected-device, Usual care
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected-deviceOther
This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.
Usual careOther
This intervention will consist of usual clinical care as determined by the clinical pharmacist.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | This arm will consist of the usual care of management of hypertension by a clinical pharmacist. Receives: Other: Usual care |
| Intervention | Active comparator | This arm will consistent of usual care plus the addition of a blood pressure cuff that will allow patients to upload data to the electronic health record via a secure portal. Receives: Other: Connected-device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure over time in control group vs. the intervention group
Difference in the change in blood pressure between the control group and intervention group.
Measured: From enrollment to 6 months later
Secondary outcomes (4)
Patient visits
Measurement of the number of in-person visits
Measured: From enrollment to 6 months later
Patient remote interactions
Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist
Measured: From enrollment to 6 months later
Medication changes
Number of changes in medication or medication dose
Measured: From enrollment to 6 months later
Blood pressure control
Time to reach target blood pressure control (Adults 18-59 years of age <140/90 mm Hg, Adults 60-85 years of age, without a diagnosis of diabetes, <150/90 mm Hg, Adults 60-85 years of age, with a diagnosis of diabetes, <140/90 mm Hg)
Measured: From enrollment to 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start26 Jul 2017
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
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 Stanford 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N. Lance Downing, MD, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291535
- Sponsor's protocol ID
- 12397
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2017
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided, this is a quality improvement project.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Hypertension Management Pilot: Randomized Evaluation of Electronic Health Record-connected Blood Pressure Cuffs in a Clinical Pharmacist Panel.
- ClinicalTrials.gov ID
- NCT03291535
- Acronym / sponsor ID
- 12397
- Conditions
- Hypertension, Electronic Health Record, Digital Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 25 Sep 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.
Investigators are examining the quality improvement impact of providing patients with a an electronic health record-connected blood pressure cuff. Investigators will give half of patients already eligible for hypertension management within a clinical pharmacist panel, the ability to upload their blood pressure data into Stanford's electronic health record.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Usual careThis arm will consist of the usual care of management of hypertension by a clinical pharmacist. |
| Intervention | Active comparator | Other: Connected-deviceThis arm will consistent of usual care plus the addition of a blood pressure cuff that will allow patients to upload data to the electronic health record via a secure portal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypertension as defined by clinical pharmacist usual care panel (2 or more readings of blood pressure >140/90)
Key exclusion criteria (4 listed)
- Pregnancy
- Chronic kidney disease III or IV
- Systolic heart failure with ejection fraction <35%
- Current use of 3 or more anti-hypertension drugs
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 |
|---|---|---|
| Connected-deviceThis intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record. | Other | Intervention |
| Usual careThis intervention will consist of usual clinical care as determined by the clinical pharmacist. | Other | Control |
Primary outcome
Change in blood pressure over time in control group vs. the intervention group
Time frame: From enrollment to 6 months later
Difference in the change in blood pressure between the control group and intervention group.
4 secondary outcomes
Patient visits
Time frame: From enrollment to 6 months later
Patient remote interactions
Time frame: From enrollment to 6 months later
Medication changes
Time frame: From enrollment to 6 months later
Blood pressure control
Time frame: From enrollment to 6 months later
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 19 Aug 2022.
- Individual participant dataSharing planned: Undecided. Undecided, this is a quality improvement project.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected-device in people with Hypertension and Electronic Health Record, run by Stanford University at 2 sites 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 4 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 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 over time in control group vs. the intervention group (time frame: From enrollment to 6 months later). 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 19 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.