Evaluation of the Epidemiological and Psychosocial Outcomes of Liver Graft Recipients Transplanted During Childhood

NCT06217965 | Recruiting

• 1 other identifier: 2023/06DEC/498
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to better characterize the adult population with a history of liver transplantation in pediatric age. In this context, the investigators will use a questionnaire to assess the participants social environment and lifestyle habits and validated scales to assess their alcohol consumption and anxiety levels. Secondly, the investigators would like to assess the participants knowledge of their disease, their experience of the transition period from pediatrics to adult medicine, and their compliance with medication.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• assessing the epidemiological and social impact of pediatric liver transplantation

  To better characterize the adult population with a history of liver transplantation in pediatric age. In this context, we will use a questionnaire to assess : * social environment (level of education, social status, employment, sexual orientation...) * lifestyle habits (risk-taking behavior, diet, exercise, weight, height…) * validated scales to assess their alcohol consumption and anxiety levels (AUDIT, BDI, STAI)

  1 year

Secondary Outcomes (1)

• assessing their knowledge of their disease, their experience of the transition period from pediatrics to adult medicine, and their compliance with medication

  1 year

Interventions

survey OTHER

The study will involve patients completing a questionnaire on a secure online platform (such as RedCap)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients who received liver transplants before the age of 18 (pediatric transplants) and who have been followed regularly at Cliniques universitaires Saint-Luc. These patients must speak French or Dutch.

You may not qualify if:

• patients minor (\< 18 years)

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Avanie Hippocrate 10

Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

RECRUITING

Related Publications (4)

• Dommergues JP, Letierce A, Descots C, Debray D. [Medical follow-up, everyday life and actual experience of young adults after liver transplantation in childhood]. Arch Pediatr. 2008 Jun;15(5):855-6. doi: 10.1016/S0929-693X(08)71940-7. No abstract available. French.

  PMID: 18582779 BACKGROUND

• Kohli R, Cortes M, Heaton ND, Dhawan A. Liver transplantation in children: state of the art and future perspectives. Arch Dis Child. 2018 Feb;103(2):192-198. doi: 10.1136/archdischild-2015-310023. Epub 2017 Sep 16.

  PMID: 28918383 BACKGROUND

• Ng VL, Alonso EM, Bucuvalas JC, Cohen G, Limbers CA, Varni JW, Mazariegos G, Magee J, McDiarmid SV, Anand R; Studies of Pediatric Liver Transplantation (SPLIT) Research Group. Health status of children alive 10 years after pediatric liver transplantation performed in the US and Canada: report of the studies of pediatric liver transplantation experience. J Pediatr. 2012 May;160(5):820-6.e3. doi: 10.1016/j.jpeds.2011.10.038. Epub 2011 Dec 20.

  PMID: 22192813 BACKGROUND

• Smith SK, Miloh T. Pediatric Liver Transplantation. Clin Liver Dis. 2022 Aug;26(3):521-535. doi: 10.1016/j.cld.2022.03.010.

  PMID: 35868688 BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Xavier Stephenne, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xavier Stephenne, MD, PhD

CONTACT

+3227641377; xavier.stephenne@saintluc.uclouvain.be

Clara Gautier, MD

CONTACT

+3227641352; clara.gautier@saintluc.uclouvain.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: January 23, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: October 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

BE (1)