Quality of Life in Pediatric Transplant Patients

Kidney Transplantation Clinical Trial

Official title:

Quality of Life and Vulnerability in Pediatric Solid Organ Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00678002
• Other study ID #: CHW 08/157
• Secondary ID: GC173
• Status: Terminated
• Start date: October 2008
• Est. completion date: November 1, 2020

Study information

• Verified date: November 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions.

Description:

There are numerous studies that report on the quality of life in solid organ transplant recipients. However, very few studies target quality of life parameters for these children and their families across all solid organ transplantation. Furthermore, no literature directly addresses a comparison of perceptions and wellness, impact on family, and vulnerability in a comparative format by these distinct, but definitely related populations.

The goal of this study is to compare parent and child perceptions of wellness and vulnerability in children who have undergone solid organ transplant. It is hypothesized that there will be significant differences between parent and child perceptions. Outcomes will be measured by using five different instruments:

1. Pediatric Quality of Life Inventory (PedsQL)

2. PedsQL Family Impact Module

3. PedsQL Family Information Form

4. Functional Status II-R

5. Child Vulnerability Scale (CVS)

Patients will be enrolled at the time of transplant listing, or after transplant. Patients and families will complete the survey once every 6 months while the patient is active on the respective transplant waiting list. After transplant, the patients and families will be asked to complete the survey once every 6 months for the first two years and annually thereafter.

This study may provide us with an improved understanding of parent and child perceptions in wellness, impact on family, and vulnerability within each transplant group. The results may also indicate trend differences between these three populations. These differences may help to provide insight into family perspectives allowing for greater anticipatory guidance and targeted interventions.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• between newborn and 21 years old

• parent/child pairs of patients listed for or who have received a liver transplant, kidney transplant, or heart transplant

Exclusion Criteria:

• unwilling or unable to participate

• not in one of the above transplant groups

• non-English speaking

Related Conditions & MeSH terms

• Heart Transplantation
• Kidney Transplantation
• Liver Transplantation

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (17)

Cole CR, Bucuvalas JC, Hornung RW, Krug S, Ryckman FC, Atherton H, Alonso MP, Balistreri WF, Kotagal U. Impact of liver transplantation on HRQOL in children less than 5 years old. Pediatr Transplant. 2004 Jun;8(3):222-7. — View Citation

Forsyth BW, Horwitz SM, Leventhal JM, Burger J, Leaf PJ. The child vulnerability scale: an instrument to measure parental perceptions of child vulnerability. J Pediatr Psychol. 1996 Feb;21(1):89-101. — View Citation

Freier MC, Babikian T, Pivonka J, Burley Aaen T, Gardner JM, Baum M, Bailey LL, Chinnock RE. A longitudinal perspective on neurodevelopmental outcome after infant cardiac transplantation. J Heart Lung Transplant. 2004 Jul;23(7):857-64. — View Citation

Goldstein SL, Graham N, Burwinkle T, Warady B, Farrah R, Varni JW. Health-related quality of life in pediatric patients with ESRD. Pediatr Nephrol. 2006 Jun;21(6):846-50. Epub 2006 Apr 20. — View Citation

Green A, McSweeney J, Ainley K, Bryant J. In my shoes: children's quality of life after heart transplantation. Prog Transplant. 2007 Sep;17(3):199-207; quiz 208. — View Citation

Manificat S, Dazord A, Cochat P, Morin D, Plainguet F, Debray D. Quality of life of children and adolescents after kidney or liver transplantation: child, parents and caregiver's point of view. Pediatr Transplant. 2003 Jun;7(3):228-35. — View Citation

Mussatto K, Tweddell J. Quality of life following surgery for congenital cardiac malformations in neonates and infants. Cardiol Young. 2005 Feb;15 Suppl 1:174-8. Review. — View Citation

Pollock-BarZiv SM, Anthony SJ, Niedra R, Dipchand AI, West LJ. Quality of life and function following cardiac transplantation in adolescents. Transplant Proc. 2003 Nov;35(7):2468-70. — View Citation

Roy, C., & Andrews, H. A. (1991). The roy adaptation model: The definitive statement. East Norwalk, Connecticut: Prentice Hall.

Schulz KH, Wein C, Boeck A, Rogiers X, Burdelski M. Cognitive performance of children who have undergone liver transplantation. Transplantation. 2003 Apr 27;75(8):1236-40. — View Citation

Stuber ML. Psychiatric aspects of organ transplantation in children and adolescents. Psychosomatics. 1993 Sep-Oct;34(5):379-87. Review. — View Citation

Sweet SC, Wong HH, Webber SA, Horslen S, Guidinger MK, Fine RN, Magee JC. Pediatric transplantation in the United States, 1995-2004. Am J Transplant. 2006;6(5 Pt 2):1132-52. — View Citation

Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. — View Citation

Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQL Family Impact Module: preliminary reliability and validity. Health Qual Life Outcomes. 2004 Sep 27;2:55. — View Citation

Wray J, Radley-Smith R. Beyond the first year after pediatric heart or heart-lung transplantation: Changes in cognitive function and behaviour. Pediatr Transplant. 2005 Apr;9(2):170-7. — View Citation

Wray J, Radley-Smith R. Depression in pediatric patients before and 1 year after heart or heart-lung transplantation. J Heart Lung Transplant. 2004 Sep;23(9):1103-10. — View Citation

Wray J, Radley-Smith R. Longitudinal assessment of psychological functioning in children after heart or heart-lung transplantation. J Heart Lung Transplant. 2006 Mar;25(3):345-52. Epub 2006 Jan 18. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Quality of Life Inventory		every 6 months
Secondary	Peds QL Family Impact Module		every 6 months
Secondary	Peds QL Family Information Form		every 6 months
Secondary	Functional Status II-R		every 6 months
Secondary	Child Vulnerability Scale		every 6 months