PrehypertensionTanya K23NCT01434953
Prehypertension Labeling
A study testing Labeled prehypertension and Unlabeled prehypertension in people with Prehypertension, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prehypertension
- What is being tested?
- Labeled prehypertension and Unlabeled prehypertension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2009to 9 Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Diagnostic Labeling: Effect on White Coat Hypertension
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.
Read the 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.
- Conditions
- Prehypertension
- Being tested
- Labeled prehypertension, Unlabeled prehypertension
- Keywords
- Prehypertension, Blood pressure screening, White coat effect
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labeled prehypertensionBehavioural
A study physician informs subjects of their blood pressure level. Subjects are told they have prehypertension and are informed of the associated health risks.
Unlabeled prehypertensionBehavioural
A study physician informs subjects of their blood pressure level. The term "prehypertension" is not used and associated health risks are not discussed.
| Study group | Role | What they receive |
|---|---|---|
| Labeled | Experimental | Not described Receives: Behavioral: Labeled prehypertension |
| Unlabeled | Active comparator | Not described Receives: Behavioral: Unlabeled prehypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured: Baseline, 3 months
Secondary outcomes (1)
Change in health-related quality of life (SF-12 questionnaires)
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study start13 Jul 2009
- Primary completion9 Jul 2012
- Study completion9 Jul 2012
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Burg, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434953
- Sponsor's protocol ID
- AAAC6382
- Acronym
- Tanya K23
- Status last verified
- Jul 2017
- First submitted
- 8 Sep 2011
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Labeling: Effect on White Coat Hypertension
- ClinicalTrials.gov ID
- NCT01434953
- Acronym / sponsor ID
- Tanya K23 / AAAC6382
- Conditions
- Prehypertension
- Keywords
- Prehypertension, Blood pressure screening, White coat effect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 13 Jul 2009 (actual)
- Primary completion
- 9 Jul 2012 (actual)
- Study completion
- 9 Jul 2012 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labeled | Experimental | Behavioral: Labeled prehypertension |
| Unlabeled | Active comparator | Behavioral: Unlabeled prehypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- past diagnosis of hypertension, prehypertension, or high blood pressure
- current or past use of antihypertensive medications
- diabetes
- renal disease
- cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labeled prehypertensionA study physician informs subjects of their blood pressure level. Subjects are told they have prehypertension and are informed of the associated health risks. | Behavioural | Labeled |
| Unlabeled prehypertensionA study physician informs subjects of their blood pressure level. The term "prehypertension" is not used and associated health risks are not discussed. | Behavioural | Unlabeled |
Primary outcome
Change in blood pressure
Time frame: Baseline, 3 months
1 secondary outcome
Change in health-related quality of life (SF-12 questionnaires)
Time frame: Baseline, 3 months
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Burg, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labeled prehypertension and Unlabeled prehypertension in people with Prehypertension, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2017.