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