Virtual Hypertension Management Pilot
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03291535|
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Electronic Health Record Digital Health||Other: Connected-device Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Virtual Hypertension Management Pilot: Randomized Evaluation of Electronic Health Record-connected Blood Pressure Cuffs in a Clinical Pharmacist Panel.|
|Actual Study Start Date :||July 26, 2017|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Placebo Comparator: Control
This arm will consist of the usual care of management of hypertension by a clinical pharmacist.
Other: Usual care
This intervention will consist of usual clinical care as determined by the clinical pharmacist.
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.
This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.
- 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.
- Patient visits [ Time Frame: From enrollment to 6 months later ]Measurement of the number of in-person visits
- Patient remote interactions [ Time Frame: From enrollment to 6 months later ]Measurement of the number of patient phone calls plus patient-portal messages to the clinical pharmacist
- Medication changes [ Time Frame: From enrollment to 6 months later ]Number of changes in medication or medication dose
- Blood pressure control [ Time Frame: From enrollment to 6 months later ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291535
|Contact: Norman Downing, MDemail@example.com|
|United States, California|
|Stanford Primary Care||Recruiting|
|Portola Valley, California, United States, 94028|
|Contact: Vanessa Guzman, PharmD 650-498-9000 firstname.lastname@example.org|
|Stanford Primary Care Clinic||Recruiting|
|Santa Clara, California, United States, 95054|
|Contact: Marcie Levine, MD 408-688-9721 email@example.com|