Prehypertension Labeling

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diagnostic Labeling: Effect on White Coat Hypertension

Conditions
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Prehypertension

Intervention / Treatment
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* Behavioral: Labeled prehypertension
* Behavioral: Unlabeled prehypertension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Labeled<br> | Behavioral: Labeled prehypertension<br>* A study physician informs subjects of their blood pressure level. Subjects are told they have prehypertension and are informed of the associated health risks.<br>|
| Active Comparator: Unlabeled<br> | Behavioral: Unlabeled prehypertension<br>* A study physician informs subjects of their blood pressure level. The term prehypertension is not used and associated health risks are not discussed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure |  | Baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health-related quality of life (SF-12 questionnaires) |  | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prehypertension, Blood pressure screening, White coat effect