Prehypertension Labeling

Not Applicable

Terminated

• Conditions: Prehypertension
• Interventions: Behavioral: Labeled prehypertension; Behavioral: Unlabeled prehypertension

• Registration Number: NCT01434953
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-07-13
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-14
• Study First Posted: 2011-09-15
• Primary Completion: 2012-07-09
• Study Completion: 2012-07-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Labeled	Labeled prehypertension	-
Unlabeled	Unlabeled prehypertension	-

Primary Outcome Measures

Name	Time	Method
Change in blood pressure	Baseline, 3 months

Secondary Outcome Measures

Name	Time	Method
Change in health-related quality of life (SF-12 questionnaires)	Baseline, 3 months

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States