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

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.

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

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.

Clinical Trials on Prehypertension

Clinical Trials on Labeled prehypertension

3
Subscribe