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Prehypertension Labeling

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01434953
First received: September 8, 2011
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Prehypertension
 Behavioral: Labeled prehypertension
Behavioral: Unlabeled prehypertension

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Screening
Official Title: Diagnostic Labeling: Effect on White Coat Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in blood pressure [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in health-related quality of life (SF-12 questionnaires) [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Labeled 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.
Active Comparator: Unlabeled 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434953

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Tanya Goyal Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01434953     History of Changes
Other Study ID Numbers: AAAC6382
Study First Received: September 8, 2011
Last Updated: September 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Prehypertension
Blood pressure screening
White coat effect

Additional relevant MeSH terms:
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013