Prehypertension Labeling (Tanya K23)

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. Identifier: NCT01434953
Recruitment Status : Terminated (PI left institution)
First Posted : September 15, 2011
Last Update Posted : July 17, 2017
Information provided by (Responsible Party):
Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prehypertension Behavioral: Labeled prehypertension Behavioral: Unlabeled prehypertension Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: Diagnostic Labeling: Effect on White Coat Hypertension
Actual Study Start Date : July 13, 2009
Actual Primary Completion Date : July 9, 2012
Actual Study Completion Date : July 9, 2012

Arm Intervention/treatment
Experimental: Labeled Behavioral: Labeled prehypertension
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 Behavioral: Unlabeled prehypertension
A study physician informs subjects of their blood pressure level. The term "prehypertension" is not used and associated health risks are not discussed.

Primary Outcome Measures :
  1. Change in blood pressure [ Time Frame: Baseline, 3 months ]

Secondary Outcome Measures :
  1. Change in health-related quality of life (SF-12 questionnaires) [ Time Frame: Baseline, 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01434953

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Principal Investigator: Matthew Burg, MD Columbia University

Responsible Party: Columbia University Identifier: NCT01434953     History of Changes
Other Study ID Numbers: AAAC6382
First Posted: September 15, 2011    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017

Keywords provided by Columbia University:
Blood pressure screening
White coat effect

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases