Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
57 participants
OBSERVATIONAL
2008-10-31
2020-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QOL###
All child subjects in this cohort will be listed for or already have received a solid organ transplant (kidney, heart, or liver).
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* parent/child pairs of patients listed for or who have received a liver transplant, kidney transplant, or heart transplant
Exclusion Criteria
* not in one of the above transplant groups
* non-English speaking
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical College of Wisconsin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stacee Lerret
Advanced Practice Nurse
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stacee Lerret, CPNP
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Gail Stendahl, CPNP
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital and Health System Foundation, Wisconsin
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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. doi: 10.1016/j.healun.2005.09.018. Epub 2006 Jan 18.
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. doi: 10.1111/j.1399-3046.2005.00265.x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GC173
Identifier Type: -
Identifier Source: secondary_id
CHW 08/157
Identifier Type: -
Identifier Source: org_study_id