HypertensionNCT00133653
The Double Exposure Study: The Impact of Job Strain and Marital Cohesion on Blood Pressure
An observational study of Hypertension, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP). In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we, the researchers at Sunnybrook and Women's College Health Sciences… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Observational
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2001to Jul 2004
- Phase
- Observational
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-65
- Unmedicated for at least 6 months
- Living with spouse for at least 6 months
- Working for at least 6 months
Who cannot join
- Working rotating or evening shifts
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: The Impact of Job Strain and Marital Cohesion on Ambulatory Blood Pressure Over One Year: The Double Exposure Study
Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP).
In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we, the researchers at Sunnybrook and Women's College Health Sciences Centre, evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.
Read the detailed description
Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP).
In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.
- Conditions
- Hypertension
- Being tested
- Observational
- Keywords
- Hypertension; Job Strain; Marital Strain; Blood Pressure
- Medical subject headings
- Hypertension, Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startAug 2001
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Sheldon W Tobe, MD, Principal investigator, Sunnybrook & Women's College Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133653
- Sponsor's protocol ID
- DE-2001
- Status last verified
- Aug 2004
- First submitted
- 22 Aug 2005
- Last updated
- 31 Oct 2005
- Results posted
- No
Publications
Baker B, Paquette M, Szalai JP, Driver H, Perger T, Helmers K, O'Kelly B, Tobe S. The influence of marital adjustment on 3-year left ventricular mass and ambulatory blood pressure in mild hypertension. Arch Intern Med. 2000 Dec 11-25;160(22):3453-8. doi: 10.1001/archinte.160.22.3453.
PubMed 11112239
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Job Strain and Marital Cohesion on Ambulatory Blood Pressure Over One Year: The Double Exposure Study
- ClinicalTrials.gov ID
- NCT00133653
- Acronym / sponsor ID
- DE-2001
- Conditions
- Hypertension
- Keywords
- Hypertension; Job Strain; Marital Strain; Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Aug 2001
- Study completion
- Jul 2004
- First posted
- 23 Aug 2005 (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.
Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP).
In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we, the researchers at Sunnybrook and Women's College Health Sciences Centre, evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.
Detailed description
Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP).
In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40-65
- Unmedicated for at least 6 months
- Living with spouse for at least 6 months
- Working for at least 6 months
Key exclusion criteria (1 listed)
- Working rotating or evening shifts
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 |
|---|---|---|
| Observational | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2005.
- Results publication: PubMed 11112239Baker B, Paquette M, Szalai JP, Driver H, Perger T, Helmers K, O'Kelly B, Tobe S. The influence of marital adjustment on 3-year left ventricular mass and ambulatory blood pressure in mild hypertension. Arch Intern Med. 2000 Dec 11-25;160(22):3453-8. doi: 10.1001/archinte.160.22.3453.
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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.
Sheldon W Tobe, MD principal investigator
Sunnybrook & Women's College Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 31 Oct 2005. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133653, which also lists 1 linked publication.
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 31 Oct 2005.