Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
Comparative Effectiveness of Ambulatory Blood Pressure Monitoring vs Usual Care for Diagnosing and Managing Hypertension: A Pilot Study
1 other identifier
interventional
28
1 country
1
Brief Summary
The purpose of this study is to compare the effectiveness of ambulatory blood pressure monitoring to usual care (blood pressure measurement in the office) in diagnosing and managing hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started May 2014
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2014
CompletedFirst Posted
Study publicly available on registry
April 23, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
December 19, 2016
CompletedFebruary 10, 2017
December 1, 2016
1.3 years
April 16, 2014
October 25, 2016
December 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24 Hour Blood Pressure Average at the End of 4 Month Participation.
Participants will be on study average of 4 months.
Study Arms (2)
Usual Care
NO INTERVENTIONParticipants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
ABPM Guided
ACTIVE COMPARATORParticipants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 30 years and ≤ 65 years
- Most recent (within 14 days) clinic systolic BP 126-150 mm Hg
- Able/willing to wear a BP monitor for 24 hours on multiple occasions
- Able/willing to take daily anti-hypertensive medication if indicated
- Able to read and speak English
You may not qualify if:
- Pregnant or trying to become pregnant
- Known heart disease
- History of persistent atrial fibrillation
- Currently taking antihypertensive medication
- Currently taking Simvastatin \> 20mg daily
- Clinician recommends against participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Anthony Viera
- Organization
- UNC Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony J Viera, MD, MPH
University of North Carolina
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Distinguished Associate Professor, Family Medicine
Study Record Dates
First Submitted
April 16, 2014
First Posted
April 23, 2014
Study Start
May 1, 2014
Primary Completion
September 1, 2015
Study Completion
July 1, 2016
Last Updated
February 10, 2017
Results First Posted
December 19, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share