Needs in Education for Pulmonary or Cardiopulmonary Transplanted Cystic Fibrosis Patients

NCT ID: NCT01285895

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Valérie DAVID, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Romain GUILLEMAIN, Profesor

Role: STUDY_CHAIR

Hôpital Européen Georges-Pompidou

Jean-François MORNEX, Profesor

Role: STUDY_CHAIR

Hospices Civils de Lyon

Marc STERN, Profesor

Role: STUDY_CHAIR

Hôpital Foch

Martine REYNAUD-GAUBERT, Profesor

Role: STUDY_CHAIR

CHU de Marseille

Marlène MURRIS-ESPIN, Doctor

Role: STUDY_CHAIR

University Hospital, Toulouse

Romain KESSLER, Profesor

Role: STUDY_CHAIR

CHU de Strasbourg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nantes University Hospital

Nantes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PROG/10/90

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lung Transplant READY Pilot Study
NCT05135156 COMPLETED NA
Cystic Fibrosis Adherence Study
NCT04217889 COMPLETED