Prehypertension Labeling

Prehypertension Clinical Trial

— Tanya K23  

Official title:

Diagnostic Labeling: Effect on White Coat Hypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01434953
• Other study ID #: AAAC6382
• Status: Terminated
• Phase: N/A
• First received: September 8, 2011
• Last updated: July 13, 2017
• Start date: July 13, 2009
• Est. completion date: July 9, 2012

Study information

• Verified date: July 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: July 9, 2012
• Est. primary completion date: July 9, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prehypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure		Baseline, 3 months
Secondary	Change in health-related quality of life (SF-12 questionnaires)		Baseline, 3 months