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Prehypertension Labeling (Tanya K23)

Primary Purpose

Prehypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Labeled prehypertension
Unlabeled prehypertension
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prehypertension focused on measuring Prehypertension, Blood pressure screening, White coat effect

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Labeled

Unlabeled

Arm Description

Outcomes

Primary Outcome Measures

Change in blood pressure

Secondary Outcome Measures

Change in health-related quality of life (SF-12 questionnaires)

Full Information

First Posted
September 8, 2011
Last Updated
July 13, 2017
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01434953
Brief Title
Prehypertension Labeling
Acronym
Tanya K23
Official Title
Diagnostic Labeling: Effect on White Coat Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
July 13, 2009 (Actual)
Primary Completion Date
July 9, 2012 (Actual)
Study Completion Date
July 9, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension
Keywords
Prehypertension, Blood pressure screening, White coat effect

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Labeled
Arm Type
Experimental
Arm Title
Unlabeled
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Labeled prehypertension
Intervention Description
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
Intervention Name(s)
Unlabeled prehypertension
Intervention Description
A study physician informs subjects of their blood pressure level. The term "prehypertension" is not used and associated health risks are not discussed.
Primary Outcome Measure Information:
Title
Change in blood pressure
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in health-related quality of life (SF-12 questionnaires)
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Burg, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Prehypertension Labeling

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