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Representations of Transplantation in Patients and in Health Care Professionals

This study is currently recruiting participants.
Verified August 2011 by Nantes University Hospital
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01285882
First received: January 27, 2011
Last updated: August 1, 2011
Last verified: August 2011
History of Changes
  Purpose

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. Identify the knowledge, representations, or feelings of patients which could constitute bridles or factors of motivation to use for transplantation.
  2. 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.
  3. 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.
  4. Identify the needs of patients, assistants and medical persons to successfully reduce these bridles to transplantation and increase the factors of motivation.
  5. Compare the representations of patients, assistants and medical persons
  6. Search representations associated with patients who refuse the transplantation and those who accept the transplantation

Condition Intervention
Cystic Fibrosis
 Other: Representations

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Representations of Transplantation in Patients With Mucoviscidosis, in Their Assistants and in Their Medical Persons

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Representations Other: Representations
  1. 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.

  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

Adult patients for whom a lung transplant indication is established

Criteria

Inclusion Criteria:

  • 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 ...)

Exclusion Criteria:

  • For patients :

    • Patient with a psychiatric disorder
    • Patient in intensive care unit
    • Palliative care patient
    • Patient aged under 18 years old
    • Patient refusal

  • For medical persons :

    • Medical person refusal

  • For assistants :

    • Assistant or patient refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285882

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: Raphaële NOVE-JOSSERAND, Doctor CHU de Lyon
Study Chair: Marc STERN, Profesor Hôpital Foch
Study Chair: Martine REYNAUD-GAUBERT, Profesor CHU de Marseille
Study Chair: Isabelle DURIEU, Doctor CHU de Lyon
Study Chair: Dominique HUBERT, Doctor Hôpital Cochin
Study Chair: Sophie RAMEL, Doctor Centre de Perharidy - Roscoff
Study Chair: RAVONINJATOVO, Doctor CHU de Reims
Study Chair: Magali DUPUY-GRASSET, Doctor University Hospital, Limoges
Study Chair: Céline MENETREY, Doctor University Hospital, Limoges
Study Chair: Chantal BELLEGUIC, Doctor CHU de Rennes
Study Chair: Corina SANZIANA CORHUT, Doctor CHU de Nancy
Study Chair: Benoît GODBERT, Doctor CHU de Nancy
Study Chair: Françoise VARAIGNE, Doctor CHU de Tours
Study Chair: Isabelle PIN, Doctor University Hospital, Grenoble
Study Chair: Marie-Laure UFFREDI, Doctor CH de Vannes
  More Information

No publications provided

Responsible Party: Anne OMNES, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01285882     History of Changes
Other Study ID Numbers: PROG/10/89
Study First Received: January 27, 2011
Last Updated: August 1, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Nantes University Hospital:
Lung transplantations
Representations
Mucoviscidosis

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 19, 2013