NCT01285895

Completed

Needs in Education for Pulmonary or Cardiopulmonary Transpla...

Nantes University Hospital Source

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Other study identifiers

Sponsor study identifier

PROG/10/90

Study Type

observational

Estimated enrollment

60

Locations

1 country

Sites

1

Timeline

Study Start

September 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2013

Actual (reported)

Study Completion

October 2013

Actual (reported)

Brief 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 60 participants
Study completion date: October 2013
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2009
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 27, 2011
Actual (reported)
First Posted
January 28, 2011
Actual (reported)
Primary Completion
October 2013
Actual (reported)
Study Completion
October 2013
Actual (reported)

Last Updated: April 15, 2015
Status Verified: April 2015
Last Update Submitted: April 14, 2015

Conditions

Cystic Fibrosis

Keywords

Lung and heart transplantationsMucoviscidosisEducational needs

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients who received a lung transplantation or a simultaeous heart-lung transplantation for mucoviscidosis

You may qualify if:

Patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis

You may not qualify if:

Patient with a psychiatric disorder
Patient in intensive care
Palliative patient

Sponsors & Collaborators

Nantes University Hospital
Otherlead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

Valérie DAVID, Doctor
Nantes University Hospital
PRINCIPAL INVESTIGATOR
Romain GUILLEMAIN, Profesor
Hôpital Européen Georges-Pompidou
STUDY CHAIR
Jean-François MORNEX, Profesor
Hospices Civils de Lyon
STUDY CHAIR
Marc STERN, Profesor
Hôpital Foch
STUDY CHAIR

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

January 28, 2011

Study Start

September 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2013

Actual (reported)

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Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis

Phase 1/2Unknown

Patient aged under 18 years old

Patient refusal

Contact the study team to confirm eligibility.

Martine REYNAUD-GAUBERT, Profesor

CHU de Marseille

STUDY CHAIR

Marlène MURRIS-ESPIN, Doctor

University Hospital, Toulouse

STUDY CHAIR

Romain KESSLER, Profesor

CHU de Strasbourg

STUDY CHAIR

Study Completion

October 2013

Actual (reported)

Last Updated

April 15, 2015

Record last verified: 2015-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01285895
Data provider: ClinicalTrials.gov
Source updated: 2015-04-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:42 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations