Quality of Life in Pediatric Transplant Patients
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Quality of Life and Vulnerability in Pediatric Solid Organ Transplant Recipients|
- Pediatric Quality of Life Inventory [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Peds QL Family Impact Module [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Peds QL Family Information Form [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Functional Status II-R [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Child Vulnerability Scale [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
All child subjects in this cohort will be listed for or already have received a solid organ transplant (kidney, heart, or liver).
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:
- Pediatric Quality of Life Inventory (PedsQL)
- PedsQL Family Impact Module
- PedsQL Family Information Form
- Functional Status II-R
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678002
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Stacee Lerret, CPNP||Medical College of Wisconsin|
|Principal Investigator:||Gail Stendahl, CPNP||Children's Hospital and Health System Foundation, Wisconsin|