Prehypertension Labeling

NCT ID: NCT01434953

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-13
• Study Completion Date: 2012-07-09

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.

Conditions

Prehypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Labeled

Group Type: EXPERIMENTAL

Labeled prehypertension

Intervention Type: BEHAVIORAL

A study physician informs subjects of their blood pressure level. Subjects are told they have prehypertension and are informed of the associated health risks.

Unlabeled

Group Type: ACTIVE_COMPARATOR

Unlabeled prehypertension

Intervention Type: BEHAVIORAL

A study physician informs subjects of their blood pressure level. The term "prehypertension" is not used and associated health risks are not discussed.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Burg, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAC6382

Identifier Type: -

Identifier Source: org_study_id