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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01285895
Other study ID # PROG/10/90
Secondary ID
Status Completed
Phase N/A
First received January 27, 2011
Last updated April 14, 2015
Start date September 2009
Est. completion date October 2013

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 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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


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, 

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