- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01434953
Prehypertension Labeling (Tanya K23)
July 13, 2017 updated by: Columbia University
Diagnostic Labeling: Effect on White Coat Hypertension
The purpose of this study is to find out whether labeling adults with prehypertension has negative effects on clinic blood pressure and quality of life 3 months after diagnosis.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Previous research has shown that a diagnosis of hypertension is associated with subsequent increases in resting blood pressure, and there is preliminary evidence of a cross-sectional association between hypertension labeling and the white coat effect.
The white coat effect may be particularly problematic in prehypertensives, because a small elevation in clinic blood pressure could result in crossing the diagnostic cutoff for hypertension, potentially leading to misdiagnosis and unnecessary treatment.
This study will examine effects of prehypertension labeling on clinic and ambulatory blood pressure, and will examine potential psychological mediators of these associations.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- at least 18 years
- average screening systolic blood pressure of 120-139 mmHg OR diastolic blood pressure of 80-89 mmHg
- average screening systolic blood pressure below 140 mmHg AND diastolic blood pressure below 90 mmHg
- able to read and write in English
Exclusion Criteria:
- past diagnosis of hypertension, prehypertension, or high blood pressure
- current or past use of antihypertensive medications
- diabetes
- renal disease
- cardiovascular disease
- current participation in another hypertension-related clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Labeled
|
A study physician informs subjects of their blood pressure level.
Subjects are told they have prehypertension and are informed of the associated health risks.
|
Active Comparator: Unlabeled
|
A study physician informs subjects of their blood pressure level.
The term "prehypertension" is not used and associated health risks are not discussed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in blood pressure
Time Frame: Baseline, 3 months
|
Baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in health-related quality of life (SF-12 questionnaires)
Time Frame: Baseline, 3 months
|
Baseline, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthew Burg, MD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2009
Primary Completion (Actual)
July 9, 2012
Study Completion (Actual)
July 9, 2012
Study Registration Dates
First Submitted
September 8, 2011
First Submitted That Met QC Criteria
September 14, 2011
First Posted (Estimate)
September 15, 2011
Study Record Updates
Last Update Posted (Actual)
July 17, 2017
Last Update Submitted That Met QC Criteria
July 13, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAC6382
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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