Prehypertension Labeling

Overview

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.

Full Title of Study: “Diagnostic Labeling: Effect on White Coat Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 9, 2012

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Labeled
  • Active Comparator: Unlabeled

Clinical Trial Outcome Measures

Primary Measures

  • Change in blood pressure
    • Time Frame: Baseline, 3 months

Secondary Measures

  • Change in health-related quality of life (SF-12 questionnaires)
    • Time Frame: Baseline, 3 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Columbia University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Matthew Burg, MD, Principal Investigator, Columbia University

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