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Prehypertension Labeling (Tanya K23)

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Columbia University

Status

Terminated

Conditions

Prehypertension

Treatments

Behavioral: Unlabeled prehypertension
Behavioral: Labeled prehypertension

Study type

Interventional

Funder types

Other

Identifiers

NCT01434953
AAAC6382

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Labeled
Experimental group
Treatment:
Behavioral: Labeled prehypertension
Unlabeled
Active Comparator group
Treatment:
Behavioral: Unlabeled prehypertension

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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