NCT01818193

Brief Summary

A monocentric prospective open study to evaluate the frequency and nature of cognitive complications in the 3rd month post pulmonary transplant.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 26, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

March 13, 2013

Last Update Submit

October 28, 2016

Conditions

Cognitive Dysfunctions

Keywords

Pulmonary transplant

Outcome Measures

Primary Outcomes (5)

  • Rey auditory verbal learning test

    3 months

  • Rey complex figure test

    3 months

  • Boston naming test of 30 figures

    3 months

  • Visual construction skills

    3 months

  • Grooved Pegboard test

    3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients enregistered in the waiting list for lung transplant

You may qualify if:

  • Patients more than 18 years of age.
  • Enregistered in lung transplant waiting list
  • Have given their agreement to be enrolled in the study

You may not qualify if:

  • Patients had a previous lung transplant
  • patients with insufficient level of french language that may affect the comprehension and answering the psychometric test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital FOCH

Suresnes, Île-de-France Region, 92150, France

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 26, 2013

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)