Representations of Transplantation in Patients and in Health Care Professionals

Cystic Fibrosis Clinical Trial

Official title:

Representations of Transplantation in Patients With Mucoviscidosis, in Their Assistants and in Their Medical Persons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285882
• Other study ID #: PROG/10/89
• Status: Completed
• Phase: N/A
• First received: January 27, 2011
• Last updated: April 14, 2015
• Start date: June 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Other:
• Representations
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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France,