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Needs in Education for Pulmonary or Cardiopulmonary Transplanted Cystic Fibrosis Patients

This study is currently recruiting participants.
Verified August 2011 by Nantes University Hospital
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01285895
First received: January 27, 2011
Last updated: August 1, 2011
Last verified: August 2011
History of Changes
  Purpose

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

Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessing of the Educational Needs of Patients Who Received a Lung Transplantation or a Simultaneous Heart-lung Transplantation for Mucoviscidosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Estimated Enrollment: 60
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who received a lung transplantation or a simultaeous heart-lung transplantation for mucoviscidosis

Criteria

Inclusion Criteria:

  • Patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis

Exclusion Criteria:

  • Patient with a psychiatric disorder
  • Patient in intensive care
  • Palliative patient
  • Patient aged under 18 years old
  • Patient refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285895

Contacts
Contact: Valérie DAVID, Doctor 02 40 08 35 30 valerie.david@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Valérie DAVID, Doctor     02 40 08 35 30     valerie.david@chu-nantes.fr    
Principal Investigator: Valérie DAVID, Doctor            
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Valérie DAVID, Doctor CHU de Nantes
Study Chair: Romain GUILLEMAIN, Profesor Hôpital Européen Georges Pompidou
Study Chair: Jean-François MORNEX, Profesor CHU de Lyon
Study Chair: Marc STERN, Profesor Hôpital Foch
Study Chair: Martine REYNAUD-GAUBERT, Profesor CHU de Marseille
Study Chair: Marlène MURRIS-ESPIN, Doctor University Hospital, Toulouse
Study Chair: Romain KESSLER, Profesor CHU de Strasbourg
  More Information

No publications provided

Responsible Party: Anne OMNES, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01285895     History of Changes
Other Study ID Numbers: PROG/10/90
Study First Received: January 27, 2011
Last Updated: August 1, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Nantes University Hospital:
Lung and heart transplantations
Mucoviscidosis
Educational needs

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013