AnticoagulantNCT03323320
Evaluation of Patient's Knowledge of Their NACO Treatment
An observational study of Anticoagulant, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
More than one million of patient receive anti vitamine K treatment which is the main cause of hospitalization. About 50 000 patient receive direct oral anticoagulant . The aim is to evaluate the patient's level of knowledge about their anticoagulant treatment and specially about the side effect Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulant
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2016to 1 Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients under AOD treatment in GHPSJ (hospitalization and consultation)
Who may be able to join
- patient with AOD treatment
- capable to answer to questionnaire
- with or without antivitamin K
Who cannot join
- dementia
- cognitive trouble
- refusing participation
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
More than one million of patient receive anti vitamine K treatment which is the main cause of hospitalization. About 50 000 patient receive direct oral anticoagulant .
The aim is to evaluate the patient's level of knowledge about their anticoagulant treatment and specially about the side effect
- Conditions
- Anticoagulant
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire score >80%
it's a questionnaire about anticoagulant treatment ; each question has a score ans for the study investigators calculate the total
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start5 Dec 2016
- Primary completion31 Mar 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulantStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain CADOR, MD, Study director, GHPSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323320
- Sponsor's protocol ID
- AOD
- Status last verified
- Feb 2018
- First submitted
- 24 Oct 2017
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient's Knowledge of Their NACO Treatment
- ClinicalTrials.gov ID
- NCT03323320
- Acronym / sponsor ID
- AOD
- Conditions
- Anticoagulant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 27 Oct 2017 (actual)
- 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.
More than one million of patient receive anti vitamine K treatment which is the main cause of hospitalization. About 50 000 patient receive direct oral anticoagulant .
The aim is to evaluate the patient's level of knowledge about their anticoagulant treatment and specially about the side effect
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients under AOD treatment in GHPSJ (hospitalization and consultation)
Key inclusion criteria (3 listed)
- patient with AOD treatment
- capable to answer to questionnaire
- with or without antivitamin K
Key exclusion criteria (3 listed)
- dementia
- cognitive trouble
- refusing participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
questionnaire score >80%
Time frame: Day 1
it's a questionnaire about anticoagulant treatment ; each question has a score ans for the study investigators calculate the total
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 27 Feb 2018.
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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.
Romain CADOR, MD study director
GHPSJ
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 Anticoagulant, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 3 inclusion and 3 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 27 Feb 2018. 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 France. 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?
questionnaire score >80% (time frame: Day 1). 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 27 Feb 2018.