Quality of Life in Pediatric Transplant Patients

Quality of Life and Vulnerability in Pediatric Solid Organ Transplant Recipients

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00678002

Enrollment

Registered

2008-05-15

Start date

2008-10-31

Completion date

2020-11-01

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation, Kidney Transplantation, Liver Transplantation

Keywords

solid organ transplant

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 21 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pediatric Quality of Life Inventory	every 6 months

Secondary

Measure	Time frame
Peds QL Family Impact Module	every 6 months
Peds QL Family Information Form	every 6 months
Functional Status II-R	every 6 months
Child Vulnerability Scale	every 6 months

Countries

United States

Outcome results