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CompletedNCT03291535Updated Aug 19, 2022

Virtual Hypertension Management Pilot

An interventional study of Connected-device and Usual care in Hypertension, Electronic Health Record and Digital Health, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-19.

Sponsored by Stanford University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 into Stanford's electronic health record.

02

Conditions studied

  • Hypertension
  • Electronic Health Record
  • Digital Health

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hypertension as defined by clinical pharmacist usual care panel (2 or more readings of blood pressure >140/90)

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Chronic kidney disease III or IV
  • Systolic heart failure with ejection fraction \<35%
  • Current use of 3 or more anti-hypertension drugs
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Placebo comparator
    Control

    This arm will consist of the usual care of management of hypertension by a clinical pharmacist.

    Other: Usual care

  • Active comparator
    Intervention

    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.

    Other: Connected-device

Interventions

  • OtherConnected-device

    This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.

  • OtherUsual care

    This intervention will consist of usual clinical care as determined by the clinical pharmacist.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to 6 months later

Secondary outcomes

  1. Patient visits

    Measurement of the number of in-person visits

    Time frame: From enrollment to 6 months later

  2. Patient remote interactions

    Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist

    Time frame: From enrollment to 6 months later

  3. Medication changes

    Number of changes in medication or medication dose

    Time frame: From enrollment to 6 months later

  4. 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)

    Time frame: From enrollment to 6 months later

06

Study locations

2 sites
  • Stanford Primary Care
    Portola Valley, California 94028, United States
  • Stanford Primary Care Clinic
    Santa Clara, California 95054, United States
07

References and documents

Individual participant data

Plan to share: Undecided — Undecided, this is a quality improvement project.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03291535
Lead sponsor
Stanford University
Responsible party
N. Lance Downing, MD (Clinical Assistant Professor of Medicine, Stanford University) — Principal investigator
First posted
Sep 25, 2017
Start date
Jul 26, 2017
Primary completion
Mar 1, 2022
Completion
Mar 1, 2022
Last update
Aug 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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