Cystic FibrosisNCT01285882
Representations of Transplantation in Patients and in Health Care Professionals
An observational study of Cystic Fibrosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Main objective : This project aims to have a better understanding of the influence of representations of patients with mucoviscidosis, their assistants and their medical persons in the choice of patients to accept or not lung transplantation. Specific objectives : 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Representations
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Dec 2012
- 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: Adult patients for whom a lung transplant indication is established
Who may be able to join
- For patients :
- Adult patient (those concerned by the suggestion of lung transplant).
- At the time of transplant indication : after the first suggestion of the medical person, before or after the preoperative graft check-up but before registration on waiting list.
- For medical persons :
- Medical persons involved in the suggestion of lung transplantation to the patients.
- For assistants :
- Adult close to the patient and that the patient sees as a resource person and advisor in his choices for the transplant : reference person having a major influence for the patient (spouse, parent, sibling, friend ...)
Who cannot join
- For patients :
- Patient with a psychiatric disorder
- Patient in intensive care unit
- Palliative care patient
- Patient aged under 18 years old
- Patient refusal
Show all 10Show fewer
- For medical persons :
- Medical person refusal
- For assistants :
- Assistant or patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Representations of Transplantation in Patients With Mucoviscidosis, in Their Assistants and in Their Medical Persons
Main objective : This project aims to have a better understanding of the influence of representations of patients with mucoviscidosis, their assistants and their medical persons in the choice of patients to accept or not lung transplantation.
Specific objectives :
- Identify the knowledge, representations, or feelings of patients which could constitute bridles or factors of motivation to use for transplantation.
- Identify the knowledge, representations, or feelings of medical persons which could constitute bridles or factors of motivation to the "encouraging" proposal to patients of lung transplant.
- Identify the knowledge, representations, or feelings of assistants which could constitute bridles or factors of motivation to the "encouragement" of lung transplantation at its close.
- Identify the needs of patients, assistants and medical persons to successfully reduce these bridles to transplantation and increase the factors of motivation.
- Compare the representations of patients, assistants and medical persons
- Search representations associated with patients who refuse the transplantation and those who accept the transplantation
- Conditions
- Cystic Fibrosis
- Being tested
- Representations
- Keywords
- Lung transplantations, Representations, Mucoviscidosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepresentationsOther
- A pre-test with 5 medical persons and 5 persons without mucoviscidosis will be realized to adjust the tools and place of the interview.
- To collect analyzable data for 30 patients, 40 patients will be included in the study. A conceptual card will be associated to a semi-structured interviews to gather information.Two subgroups will be considered in th a analysis :
- 1st sub-group : After the announcement of the transplant indication by the doctor and before the consultation in the transplant centre.
- 2nd subgroup : After the consultation in the transplant centre but before the inscription on the waiting list. The analysis of conceptual cards in these two subgroups will permit to study the differences between the representations of patients before and after the consultation in the transplant centre.
- Realize a 2nd interview on the same principle with all patients, 1 year after their lung transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Representations | Not described Receives: Other: Representations |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJun 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Valérie DAVID, Doctor, Principal investigator, Nantes University HospitalRaphaële NOVE-JOSSERAND, Doctor, Study chair, Hospices Civils de LyonMarc STERN, Profesor, Study chair, Hôpital FochMartine REYNAUD-GAUBERT, Profesor, Study chair, CHU de MarseilleIsabelle DURIEU, Doctor, Study chair, Hospices Civils de LyonDominique HUBERT, Doctor, Study chair, Hôpital CochinSophie RAMEL, Doctor, Study chair, Centre de Perharidy - RoscoffRAVONINJATOVO, Doctor, Study chair, CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285882
- Sponsor's protocol ID
- PROG/10/89
- Status last verified
- Apr 2015
- First submitted
- 27 Jan 2011
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Representations of Transplantation in Patients With Mucoviscidosis, in Their Assistants and in Their Medical Persons
- ClinicalTrials.gov ID
- NCT01285882
- Acronym / sponsor ID
- PROG/10/89
- Conditions
- Cystic Fibrosis
- Keywords
- Lung transplantations, Representations, Mucoviscidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 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.
Main objective : This project aims to have a better understanding of the influence of representations of patients with mucoviscidosis, their assistants and their medical persons in the choice of patients to accept or not lung transplantation.
Specific objectives :
- Identify the knowledge, representations, or feelings of patients which could constitute bridles or factors of motivation to use for transplantation.
- Identify the knowledge, representations, or feelings of medical persons which could constitute bridles or factors of motivation to the "encouraging" proposal to patients of lung transplant.
- Identify the knowledge, representations, or feelings of assistants which could constitute bridles or factors of motivation to the "encouragement" of lung transplantation at its close.
- Identify the needs of patients, assistants and medical persons to successfully reduce these bridles to transplantation and increase the factors of motivation.
- Compare the representations of patients, assistants and medical persons
- Search representations associated with patients who refuse the transplantation and those who accept the transplantation
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Representations | – | Other: Representations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients for whom a lung transplant indication is established
Key inclusion criteria (7 listed)
- For patients :
- For medical persons :
- For assistants :
Key exclusion criteria (10 listed)
- For patients :
- For medical persons :
- For assistants :
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 |
|---|---|---|
| Representations1. A pre-test with 5 medical persons and 5 persons without mucoviscidosis will be realized to adjust the tools and place of the interview. 2. To collect analyzable data for 30 patients, 40 patients will be included in the study. A conceptual card will be associated to a semi-structured interviews to gather information.Two subgroups will be considered in th a analysis : * 1st sub-group : After the announcement of the transplant indication by the doctor and before the consultation in the transplant centre. * 2nd subgroup : After the consultation in the transplant centre but before the inscription on the waiting list. The analysis of conceptual cards in these two subgroups will permit to study the differences between the representations of patients before and after the consultation in the transplant centre. 3. Realize a 2nd interview on the same principle with all patients, 1 year after their lung transplantation. | Other | Representations |
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 15 Apr 2015.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
Valérie DAVID, Doctor principal investigator
Nantes University Hospital
Raphaële NOVE-JOSSERAND, Doctor study chair
Hospices Civils de Lyon
Marc STERN, Profesor study chair
Hôpital Foch
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 Cystic Fibrosis, run by Nantes University Hospital 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 7 inclusion and 10 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 15 Apr 2015. 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.
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 15 Apr 2015.