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Kidney TransplantationNCT00678002

Quality of Life in Pediatric Transplant Patients

An observational study of Kidney Transplantation and Liver Transplantation, run by Medical College of Wisconsin at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 21 years
How many people
57 participants
Where
1 siteUnited States
Study dates
Oct 2008to 1 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Children's Hospital of Wisconsin in the Hepatology Clinic, Cardiology Clinic, and Kidney Clinic.

Who may be able to join

  • 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

Who cannot join

  • unwilling or unable to participate
  • not in one of the above transplant groups
  • non-English speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: Quality of Life and Vulnerability in Pediatric Solid Organ Transplant Recipients

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.

Read the 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.

Keywords
solid organ transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00678002
Study groupRoleWhat they receive
QOL###All child subjects in this cohort will be listed for or already have received a solid organ transplant (kidney, heart, or liver).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pediatric Quality of Life Inventory

    Measured: every 6 months

Secondary outcomes (4)

  1. Peds QL Family Impact Module

    Measured: every 6 months

  2. Peds QL Family Information Form

    Measured: every 6 months

  3. Functional Status II-R

    Measured: every 6 months

  4. Child Vulnerability Scale

    Measured: every 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2008 (estimated)
  2. Study startOct 2008
  3. Primary completion1 Nov 2020
  4. Study completion1 Nov 2020

Why it stopped: Poor enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00678002
Sponsor's protocol ID
CHW 08/157
Other IDs
GC173
Status last verified
Nov 2020
First submitted
12 May 2008
Last updated
30 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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. doi: 10.1111/j.1399-3046.2004.00126.x.

    PubMed 15176957

  • 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.

    PubMed 8820075

  • 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. doi: 10.1016/j.healun.2003.08.003.

    PubMed 15261181

  • 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. doi: 10.1007/s00467-006-0081-y. Epub 2006 Apr 20.

    PubMed 16703376

  • 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. doi: 10.1177/152692480701700307.

    PubMed 17944159

  • 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. doi: 10.1034/j.1399-3046.2003.00065.x.

    PubMed 12756049

  • 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. doi: 10.1017/s1047951105001253. No abstract available.

    PubMed 15934713

  • 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. doi: 10.1016/j.transproceed.2003.08.028.

    PubMed 14611988

  • 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. doi: 10.1097/01.TP.0000062843.10397.32.

    PubMed 12717209

  • Stuber ML. Psychiatric aspects of organ transplantation in children and adolescents. Psychosomatics. 1993 Sep-Oct;34(5):379-87. doi: 10.1016/S0033-3182(93)71840-X.

    PubMed 8140186

  • 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.

    PubMed 16613592

  • 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.

    PubMed 11468499

  • 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.

    PubMed 15450120

  • 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.

    PubMed 15454178

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplantation and Liver Transplantation, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pediatric Quality of Life Inventory (time frame: every 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00678002, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.

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