Clinical trial NCT00678002: Quality of Life in Pediatric Transplant Patients
Official title: Quality of Life and Vulnerability in Pediatric Solid Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Transplantation
Liver Transplantation
Heart Transplantation
Keywords: solid organ transplant
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 57
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children's Hospital of Wisconsin in the Hepatology Clinic, Cardiology Clinic, and Kidney Clinic.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pediatric Quality of Life Inventory
timeFrame: every 6 months
Secondary outcomes:
measure: Peds QL Family Impact Module
timeFrame: every 6 months
measure: Peds QL Family Information Form
timeFrame: every 6 months
measure: Functional Status II-R
timeFrame: every 6 months
measure: Child Vulnerability Scale
timeFrame: every 6 months
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Stacee Lerret, CPNP
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Gail Stendahl, CPNP
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1093/jpepsy/21.1.89.
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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. doi: 10.1111/j.1600-6143.2006.01271.x.
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. doi: 10.1097/00005650-200108000-00006.
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. doi: 10.1186/1477-7525-2-55.
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. doi: 10.1016/j.healun.2003.08.018.
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