NCT04667806

Brief Summary

The aim of this study is to study the quality of life in lung transplant patients. The cohort includes all of the surviving and transplanted patients at the New Civil Hospital in Strasbourg between 2008 and 2018. The main objective is to assess the quality of life of this cohort by two questionnaires which are the SF36 (generic score) and the saint Georges's questionnaire (specific score). The secondary objectives are the measurement of survival after lung transplantation, the comparison of the quality of life of these patients with that of the general population by the SF36 questionnaire, the search for perioperative factors influencing the quality of life and finally the search for an association between quality of life and socio-professional life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 24, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

November 24, 2020

Last Update Submit

March 29, 2021

Conditions

Lung Transplantation

Keywords

Health related quality of lifeLung transplantationSF36St Georges's Respiratory

Outcome Measures

Primary Outcomes (2)

  • Health related quality of life

    Score obtained by a questionnaire : SF36

    12 month

  • Health related quality of life

    Score obtained by a questionnaire : St Georges

    12 month

Interventions

QuestionnairesBEHAVIORAL

Use questionnaires ( SF36 questionnaire (generic score) and St Georges's questionnaire (specific score))

Eligibility Criteria

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

Transplants survivors in Strasbourg hospital between 2008 et 2018

You may qualify if:

  • Transplants survivors in Strasbourg hospital between 2008 et 2018
  • Patient able to answer a questionnaire in french

You may not qualify if:

  • Pregnancy
  • Vulnerability
  • Safeguard of justice, curatorship or tutorship
  • Emergency situation
  • Difficilty in understanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Lina JAZAERLI

CONTACT

+ 33 3 69 55 16 22lina.jazaerli@chru-strasbourg.fr

Study Design

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

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 16, 2020

Study Start

April 1, 2021

Primary Completion

April 1, 2021

Study Completion

April 1, 2022

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

FR(1)