Health Related Quality of Life in Lung Transplantation in Strasbourg

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04667806
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 83.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Transplantation	Behavioral: Questionnaires

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Study of the Quality of Life in Surviving Lung Transplant Patients Between 2008 and 2018 by SF36 and St Georges's Questionnaires
• Anticipated Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2021
• Anticipated Study Completion Date: Apr 1, 2022

Outcome Measures

Primary Outcome Measures

1. Health related quality of life [12 month]

   Score obtained by a questionnaire : SF36

2. Health related quality of life [12 month]

   Score obtained by a questionnaire : St Georges

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Transplants survivors in Strasbourg hospital between 2008 et 2018

• Patient able to answer a questionnaire in french

Exclusion Criteria:

• Pregnancy

• Vulnerability

• Safeguard of justice, curatorship or tutorship

• Emergency situation

• Difficilty in understanding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Les Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67000

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT04667806
• Other Study ID Numbers: 7952
• First Posted: Dec 16, 2020
• Last Update Posted: Mar 30, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Strasbourg, France: Health related quality of life; Lung transplantation; SF36; St Georges's Respiratory

Study Results

No Results Posted as of Mar 30, 2021