Cystic FibrosisNCT01285895
Needs in Education for Pulmonary or Cardiopulmonary Transplanted Cystic Fibrosis Patients
An observational study of Cystic Fibrosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Main objective : This project aims to assess the educational needs of patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Oct 2013
- 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 who received a lung transplantation or a simultaeous heart-lung transplantation for mucoviscidosis
Who may be able to join
- Patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis
Who cannot join
- Patient with a psychiatric disorder
- Patient in intensive care
- Palliative patient
- Patient aged under 18 years old
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing of the Educational Needs of Patients Who Received a Lung Transplantation or a Simultaneous Heart-lung Transplantation for Mucoviscidosis
Main objective : This project aims to assess the educational needs of patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis.
Specific objectives : Evaluate the specific needs dependent on seniority transplantation : 3 to 6 months, 6 months to 2 years, more than 2 years after transplantation
Read more
Secondary objectives :
- Assess the state of health
- Assess the knowledge
- Assess gestural know-how
- Assess the cognitive know-how
- Assess the behaviour adopted in reality by the patient
- Assess motivation psychosocial factors of :
- self-efficacy and inefficiency
- representation of obstacles, disadvantages of treatment
- sense of control over their health
- feeling of being supported by health professionals, by his close
- representation of his responsibility to take care of his health, to follow his treatment, to be active about his treatment
- Conditions
- Cystic Fibrosis
- Keywords
- Lung and heart transplantations, Mucoviscidosis, Educational needs
- Medical subject headings
- Cystic Fibrosis
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 startSep 2009
- Primary completionOct 2013
- Study completionOct 2013
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie DAVID, Doctor, Principal investigator, Nantes University HospitalRomain GUILLEMAIN, Profesor, Study chair, Hôpital Européen Georges-PompidouJean-François MORNEX, Profesor, Study chair, Hospices Civils de LyonMarc STERN, Profesor, Study chair, Hôpital FochMartine REYNAUD-GAUBERT, Profesor, Study chair, CHU de MarseilleMarlène MURRIS-ESPIN, Doctor, Study chair, University Hospital, ToulouseRomain KESSLER, Profesor, Study chair, CHU de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285895
- Sponsor's protocol ID
- PROG/10/90
- 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
- Assessing of the Educational Needs of Patients Who Received a Lung Transplantation or a Simultaneous Heart-lung Transplantation for Mucoviscidosis
- ClinicalTrials.gov ID
- NCT01285895
- Acronym / sponsor ID
- PROG/10/90
- Conditions
- Cystic Fibrosis
- Keywords
- Lung and heart transplantations, Mucoviscidosis, Educational needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (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 assess the educational needs of patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis.
Specific objectives : Evaluate the specific needs dependent on seniority transplantation : 3 to 6 months, 6 months to 2 years, more than 2 years after transplantation
Secondary objectives :
- Assess the state of health
- Assess the knowledge
- Assess gestural know-how
- Assess the cognitive know-how
- Assess the behaviour adopted in reality by the patient
- Assess motivation psychosocial factors of :
- self-efficacy and inefficiency
- representation of obstacles, disadvantages of treatment
- sense of control over their health
- feeling of being supported by health professionals, by his close
- representation of his responsibility to take care of his health, to follow his treatment, to be active about his treatment
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received a lung transplantation or a simultaeous heart-lung transplantation for mucoviscidosis
Key inclusion criteria (1 listed)
- Patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis
Key exclusion criteria (5 listed)
- Patient with a psychiatric disorder
- Patient in intensive care
- Palliative patient
- Patient aged under 18 years old
- Patient refusal
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
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.
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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.
Valérie DAVID, Doctor principal investigator
Nantes University Hospital
Romain GUILLEMAIN, Profesor study chair
Hôpital Européen Georges-Pompidou
Jean-François MORNEX, Profesor study chair
Hospices Civils de Lyon
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 1 inclusion and 5 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.