Prehypertension Labeling

Diagnostic Labeling: Effect on White Coat Hypertension

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01434953

Acronym

Tanya K23

Enrollment

100

Registered

2011-09-15

Start date

2009-07-13

Completion date

2012-07-09

Last updated

2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prehypertension

Keywords

Prehypertension, Blood pressure screening, White coat effect

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.

Interventions

BEHAVIORALLabeled 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.

BEHAVIORALUnlabeled prehypertension

A study physician informs subjects of their blood pressure level. The term prehypertension is not used and associated health risks are not discussed.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Change in blood pressure	Baseline, 3 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026