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Default BP Medication Intensification

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994408
Recruitment Status : Terminated (slow enrollment)
First Posted : November 25, 2013
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Florian Rader, MD, MSc, Cedars-Sinai Medical Center

Brief Summary:
High blood pressure leads to heart attacks and strokes which can be prevented by blood pressure-lowering medication. However, the current office-based prescription of one pill and one dose at a time is ineffective. the investigators want to pilot-test a more effective patient-centered treatment approach, where patients will receive a prescription with gradual but automatic weekly increases of dose and number of pills. Patients will measure their blood pressure with an iPhone compatible cuff, which transmits readings to the doctor or pharmacist, who will stop escalation when the desired blood pressure level is reached. The investigators hypothesize that the intervention will decrease the time to control blood pressure and increase the overall rate of blood pressure control. Therefore, this new treatment model could prevent heart attacks and strokes, and reduce healthcare costs.

Condition or disease Intervention/treatment Phase
Hypertension Other: default intensification Phase 1 Phase 2

Detailed Description:
This is a pilot 2A trial of an innovative behavioral economics theory-based antidote for physician inertia in the medical treatment of hypertension (HTN). In the current reactive physician-centered model, blood pressure (BP) is measured and medical decisions are made in the physician office; when deciding whether or not to prescribe new medication for a high office BP reading, the physician's default behavior is inaction. The investigators propose default medication intensification as a new patient-centered/pharmacist-assisted proactive treatment model to eliminate physician inertia. For enrolled patients with office BP>155/95, the physician will prescribe a one-month protocol that automatically escalates drug dose and drug number each week. The pharmacist will fill the prescription in a blister pack to simplify adherence. The patient will measure daily home BP with an iPhone cuff that transmits the data electronically to the pharmacist, who will halt the protocol if goal home BP<135/85 is achieved ahead of schedule. the investigators will pilot test the feasibility and safety of self-monitoring plus the new automatic intensification protocol packaged in blisters. Default medication intensification could revolutionize HTN treatment and reduce healthcare costs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: default drug escalation
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Automatic Medication Increase Protocol in the Treatment of Elevated Blood Pressure
Study Start Date : November 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: default intensification arm (all)
all subjects will receive blister packs with weekly increasing blood pressure medications. There is no control arm for this study
Other: default intensification
The investigators will determine which blood pressure medications to use. No specific drug will be tested but rather the automatic intensification of medications is the intervention. Examples of drugs used in this study are calcium channel blockers (e.g., amlodipine 2.5 mg to 10 mg) or ACE-inhibitors (e.g., lisinopril 5 mg to 40 mg) or diuretics (HCTZ 25 mg).
Other Name: weekly increasing blood pressure medications.




Primary Outcome Measures :
  1. Symptomatic hypotension [ Time Frame: from enrollment to 12 weeks ]
    Primary safety outcome is symptomatic hypotension during study participation (12 weeks). Safety monitoring will be achieved with patient-directed iPhone-based BP measuring and transmitting to study staff.


Secondary Outcome Measures :
  1. hypertension control rate [ Time Frame: at 12 weeks ]
    The investigators will assess blood pressure throughout the study period (12 weeks) with iPhone based technology. Hypertension control is defined as home blood pressure <135/85 mmHg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 55 years old
  • office BP of ≥160 mmHg systolic and ≥100 mmHg diastolic (treated or untreated) AND <180 mmHg systolic.

Exclusion Criteria:

  • chronic kidney disease
  • symptomatic coronary artery disease
  • congestive heart failure
  • more than mild valvular heart disease
  • Diabetes mellitus
  • obstructive left ventricular hypertrophy
  • severe electrolyte abnormalities
  • multiple medication intolerances
  • orthostatic hypotension
  • cognitive impairment and mental disorders affecting ability to self-monitor BP
  • patients who are unwilling to measure and transmit BP readings throughout the study

Information from the National Library of Medicine

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): NCT01994408


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
University of California, Los Angeles
Investigators
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Principal Investigator: Florian Rader, MD Cedars-Sinai Medical Center
Publications:
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Responsible Party: Florian Rader, MD, MSc, Assistant Professor, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01994408    
Other Study ID Numbers: Pro00030558
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Keywords provided by Florian Rader, MD, MSc, Cedars-Sinai Medical Center:
physician inertia
hypertension
telemedicine
mobile technology
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases