NCT01434953

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2012

Completed
Last Updated

July 17, 2017

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

September 8, 2011

Last Update Submit

July 13, 2017

Conditions

Prehypertension

Keywords

PrehypertensionBlood pressure screeningWhite coat effect

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

    Baseline, 3 months

Secondary Outcomes (1)

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

    Baseline, 3 months

Study Arms (2)

Labeled

EXPERIMENTAL
Behavioral: Labeled prehypertension

Unlabeled

ACTIVE COMPARATOR
Behavioral: Unlabeled prehypertension

Interventions

Labeled prehypertensionBEHAVIORAL

A study physician informs subjects of their blood pressure level. Subjects are told they have prehypertension and are informed of the associated health risks.

Labeled
Unlabeled prehypertensionBEHAVIORAL

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

Unlabeled

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Matthew Burg, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 15, 2011

Study Start

July 13, 2009

Primary Completion

July 9, 2012

Study Completion

July 9, 2012

Last Updated

July 17, 2017

Record last verified: 2017-07

Locations

US(1)