Cardiac DiseaseINFOCORONCT02484144
Evaluation of the Information of the Patient Before a Scheduled Coronarography
An observational study of Cardiac Disease, run by French Cardiology Society at 40 sites in France.
Trial summary
French study, multicentrique with the cooperation of several hospital centers . 700 patients (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a anonymous way. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- modern information and usual information
- How many people
- 821 participants
- Where
- 40 sitesFrance
- Study dates
- Jul 2015to Feb 2016
- 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 with scheduled coronarography
Who may be able to join
- hospitalisation for scheduled coronarography
Who cannot join
- Coronarographies with general anesthesia.
- Patients not speaking or not reading French, or having linguistic knowledge not allowing the delivery of an appropriate information
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
France40 sites
CHU Amiens
Amiens
CHU Jean MINJOZ
Besançon, 25030
Chu Avicennes
Bobigny
Chu Brest
Brest
Hôpital Cardiologique Louis Pradel
Bron
Ch Chartres
Chartres
Hôpital Gabriel Montpied
Clermont-Ferrand
Chu Mondor
Crétail
CHU Dijon
Dijon
Chu Grenoble
Grenoble
CH Lagny
Jossigny
CH MANS
Le Mans
Chru Lille
Lille
CH
Mâcon
Chu Marseille
Marseille
CH d'ANNECY-GENEVOIS
Metz-Tessy
Groupe intercommunal Le Raincy Montfermeil
Montfermeil
CHRU
Montpellier
CHI André Grégoire
Montreuil
CHU Nord LAENNEC
Nantes
Clinique Ambroise Paré
Neuilly-sur-Seine
Chu Nimes
Nîmes
Chu Pitie Salpetriere
Paris, 75013
European Georges Pompidou Hospital
Paris, 75015
Bichat
Paris
Chu Ambroise Paré
Paris
CHU Saint Antoine
Paris
Cochin
Paris
Lariboisière
Paris
Ch Perpignan
Perpignan
Hopital Cardiologique Haut Lévèque
Pessac
CHU Poitiers
Poitiers
Chu Reims
Reims
Chu Rennes
Rennes, 35000
CH Yves Le FOLL
Saint-Brieuc
Centre Cardiologique du Nord
Saint-Denis, 93200
Chu Strasbourg
Strasbourg
CHU Toulouse Rangueil
Toulouse, 31059
Hôpital Trousseau
Tours
CHRU Nancy
Vandœuvre-lès-Nancy
About this study
French study, multicentrique with the cooperation of several hospital centers . 700 patients (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a anonymous way.
Read the detailed description
Stage 1: evaluation of the score in the population and the evaluation of the improvement of the score after an information more detailed by the educational video.
For that purpose, inclusion on one week with comparison of the score obtained during a classic information with delivery of the sheet of information and during a classic information followed by an information more detailed with educational video.
Check during this stage of the significant improvement of the score with the addition of the educational video literally of information and in the oral information supplied usually within the framework of the current care Evaluation of the number of subject included in the 1 week. Stage 2: Comparison of the patient understanding between 2 groups: 1 group received the information by using the information targeted with educational video (modern information) and the other group the classic information considered as the reference.
Inclusion planned over 2 weeks with for every center 1 week of classic information and 1 week of targeted information, allowing a randomized comparison of the 2 methods.
To limit the biases of inclusions and the effect centers, every center will realize 1 week of every method, according to a specific drawing lots in every center to determine with which information (classic or targeted) the study will begin.
- Conditions
- Cardiac Disease
- Being tested
- modern information, usual information
- Keywords
- information, coronarography, understanding
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modern informationOther
information by video for coronarography
usual informationOther
usual information for coronarography
| Study group | Role | What they receive |
|---|---|---|
| patients receive usual information | Patients receive usual information before Scheduled Coronarography Receives: Other: usual information | |
| patients receive modern information | Patients receive usual information and a information by video before Scheduled Coronarography Receives: Other: modern information; Other: usual information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of the quality of the information of the patients
Improvement of the quality of the information of the patients by a video about the coronarography (realization of the procedure, the profits and the risks) associated with a written information. The quality of the information will be estimated by a dedicated score.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionFeb 2016
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 Cardiac DiseaseStudies 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
- Time perspective
- Prospective
- Enrolment
- 821 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484144
- Sponsor's protocol ID
- 2014-04
- Acronym
- INFOCORO
- Status last verified
- Oct 2016
- First submitted
- 24 Jun 2015
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lattuca B, Barber-Chamoux N, Alos B, Sfaxi A, Mulliez A, Miton N, Levasseur T, Servoz C, Derimay F, Hachet O, Motreff P, Metz D, Lairez O, Mewton N, Belle L, Akodad M, Mathivet T, Ecarnot F, Pollet J, Danchin N, Steg PG, Juilliere Y, Bouleti C; INFOCORO investigators. Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial. Am Heart J. 2018 Jun;200:67-74. doi: 10.1016/j.ahj.2018.03.006. Epub 2018 Mar 12.
PubMed 29898851
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Information of the Patient Before a Scheduled Coronarography
- ClinicalTrials.gov ID
- NCT02484144
- Acronym / sponsor ID
- INFOCORO / 2014-04
- Conditions
- Cardiac Disease
- Keywords
- information, coronarography, understanding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 821 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Jun 2015 (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.
French study, multicentrique with the cooperation of several hospital centers . 700 patients (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a anonymous way.
Detailed description
Stage 1: evaluation of the score in the population and the evaluation of the improvement of the score after an information more detailed by the educational video.
For that purpose, inclusion on one week with comparison of the score obtained during a classic information with delivery of the sheet of information and during a classic information followed by an information more detailed with educational video.
Check during this stage of the significant improvement of the score with the addition of the educational video literally of information and in the oral information supplied usually within the framework of the current care Evaluation of the number of subject included in the 1 week. Stage 2: Comparison of the patient understanding between 2 groups: 1 group received the information by using the information targeted with educational video (modern information) and the other group the classic information considered as the reference.
Inclusion planned over 2 weeks with for every center 1 week of classic information and 1 week of targeted information, allowing a randomized comparison of the 2 methods.
To limit the biases of inclusions and the effect centers, every center will realize 1 week of every method, according to a specific drawing lots in every center to determine with which information (classic or targeted) the study will begin.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients receive usual information | – | Other: usual informationPatients receive usual information before Scheduled Coronarography |
| patients receive modern information | – | Other: modern information, Other: usual informationPatients receive usual information and a information by video before Scheduled Coronarography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with scheduled coronarography
Key inclusion criteria (1 listed)
- hospitalisation for scheduled coronarography
Key exclusion criteria (2 listed)
- Coronarographies with general anesthesia.
- Patients not speaking or not reading French, or having linguistic knowledge not allowing the delivery of an appropriate information
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 |
|---|---|---|
| modern informationinformation by video for coronarography | Other | patients receive modern information |
| usual informationusual information for coronarography | Other | patients receive modern information, patients receive usual information |
Primary outcome
Improvement of the quality of the information of the patients
Time frame: one day
Improvement of the quality of the information of the patients by a video about the coronarography (realization of the procedure, the profits and the risks) associated with a written information. The quality of the information will be estimated by a dedicated score.
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 14 Oct 2016.
- Derived from this study: PubMed 29898851Lattuca B, Barber-Chamoux N, Alos B, Sfaxi A, Mulliez A, Miton N, Levasseur T, Servoz C, Derimay F, Hachet O, Motreff P, Metz D, Lairez O, Mewton N, Belle L, Akodad M, Mathivet T, Ecarnot F, Pollet J, Danchin N, Steg PG, Juilliere Y, Bouleti C; INFOCORO investigators. Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial. Am Heart J. 2018 Jun;200:67-74. doi: 10.1016/j.ahj.2018.03.006. Epub 2018 Mar 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by French Cardiology Society at 40 sites 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 1 inclusion and 2 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites 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?
Improvement of the quality of the information of the patients (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484144, 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 14 Oct 2016.