Cardiovascular DiseaseNCT00724399
Preventive Health Practices in Women
An observational study of Cardiovascular Disease, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to evaluate women's level of knowledge and health practices regarding cardiovascular health and identify barriers to appropriate health practice. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Survey on womens health Issues.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,418 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2015
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Prospective survey study on women who attend screening mammography and routine/annual gynecology visits to assess baseline knowledge regarding CVD.
Who may be able to join
- Women attending screening mammography and gynecology visit.
Who cannot join
- Patient refusal to participate (assessed by non-submission of the completed survey).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
The purpose of this study is to evaluate women's level of knowledge and health practices regarding cardiovascular health and identify barriers to appropriate health practice.
Read the detailed description
Increasingly, gender differences in manifestation of cardiovascular disease (CVD) and myocardial infarction (MI) are being reported. Gender specific presentations of MI in particular have contributed to underdiagnosis of cardiac events in women. Furthermore, previous studies from the 2002 Behavioral Risk Factors Screening Surveillance demonstrated decreased compliance with standard cardiovascular health practices in women compared to men. We seek to validate these findings in a population of women undergoing screening mammography and annual gynecology visit to identify current state of knowledge regarding cardiovascular risk in women.
- Conditions
- Cardiovascular Disease
- Being tested
- Survey on womens health Issues.
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey on womens health Issues.Behavioural
Cardiovascular health.
| Study group | Role | What they receive |
|---|---|---|
| Observations | Women attending screening mammography and gynecology visit Receives: Behavioral: Survey on womens health Issues. | |
| A | Women attending their annual screening mammography and gynecology clinic visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate findings in a population of women undergoing screening mammography and annual gynecology visit to identify current state of knowledge regarding cardiovascular risk in women.
Measured: To be determined later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJan 2006
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Carlos M.D., University of Michigan
- Investigators
- Ruth Carlos, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724399
- Sponsor's protocol ID
- HUM00010173
- Status last verified
- Dec 2016
- First submitted
- 24 Jul 2008
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Health Practices in Women
- ClinicalTrials.gov ID
- NCT00724399
- Acronym / sponsor ID
- HUM00010173
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,418 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Jul 2008 (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 evaluate women's level of knowledge and health practices regarding cardiovascular health and identify barriers to appropriate health practice.
Detailed description
Increasingly, gender differences in manifestation of cardiovascular disease (CVD) and myocardial infarction (MI) are being reported. Gender specific presentations of MI in particular have contributed to underdiagnosis of cardiac events in women. Furthermore, previous studies from the 2002 Behavioral Risk Factors Screening Surveillance demonstrated decreased compliance with standard cardiovascular health practices in women compared to men. We seek to validate these findings in a population of women undergoing screening mammography and annual gynecology visit to identify current state of knowledge regarding cardiovascular risk in women.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observations | – | Behavioral: Survey on womens health Issues.Women attending screening mammography and gynecology visit |
| A | – | –Women attending their annual screening mammography and gynecology clinic visits. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective survey study on women who attend screening mammography and routine/annual gynecology visits to assess baseline knowledge regarding CVD.
Key inclusion criteria (1 listed)
- Women attending screening mammography and gynecology visit.
Key exclusion criteria (1 listed)
- Patient refusal to participate (assessed by non-submission of the completed survey).
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 |
|---|---|---|
| Survey on womens health Issues.Cardiovascular health. | Behavioural | Observations |
Primary outcome
To validate findings in a population of women undergoing screening mammography and annual gynecology visit to identify current state of knowledge regarding cardiovascular risk in women.
Time frame: To be determined later
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 16 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Ruth Carlos, MD principal investigator
University of Michigan
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 Cardiovascular Disease, run by University of Michigan 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 1 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 16 Dec 2016. 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 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.
What does the primary outcome measure?
To validate findings in a population of women undergoing screening mammography and annual gynecology visit to identify current state of knowledge regarding cardiovascular risk in women. (time frame: To be determined later). 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 16 Dec 2016.