Overview

This trial is active, not recruiting.

Condition prehypertension
Treatments labeled prehypertension, unlabeled prehypertension
Sponsor Columbia University
Start date July 2009
End date September 2011
Trial size 100 participants
Trial identifier NCT01434953, AAAC6382

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose screening
Arm
(Experimental)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Change in blood pressure
time frame: Baseline, 3 months

Secondary Outcomes

Measure
Change in health-related quality of life (SF-12 questionnaires)
time frame: Baseline, 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Diagnostic Labeling: Effect on White Coat Hypertension
Principal investigator Tanya Goyal
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Columbia University.