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Needs in Education for Pulmonary or Cardiopulmonary Transplanted Cystic Fibrosis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285895
First Posted: January 28, 2011
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
  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:


Further study details as provided by Nantes University Hospital:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285895


Locations
France
Nantes University Hospital
Nantes, France, 44093
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

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01285895     History of Changes
Other Study ID Numbers: PROG/10/90
First Submitted: January 27, 2011
First Posted: January 28, 2011
Last Update Posted: April 15, 2015
Last Verified: April 2015

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

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