Quality of Life in Pediatric Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Laura L. Mee, Emory University
ClinicalTrials.gov Identifier:
NCT00209196
First received: September 14, 2005
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

Adherence to medical regimens refers to what degree a patient chooses to follow the advice given by his/her healthcare provider. Good adherence typically involves behaviors such as the patient taking medication as directed and going to scheduled clinic appointments. As many patients often do not follow the advice of doctors as closely as suggested, many researchers have tried to find out the reasons behind patients being "non-adherent." This research has looked at medical conditions such as diabetes, cystic fibrosis, and asthma. More recently, researchers have started to look at adherence with children who have undergone solid organ transplantation. This is because about 50% of these children are to some degree non-adherent with their medical regimen. This comes at a costly price as ongoing non-adherence in pediatric transplant can lead to the child's body rejecting the new organ and even death. This study has been designed to look at the reasons that pediatric patients may choose to be non-adherent. This study will look at issues related to the patient (e.g., age, family support), related to the disease and regimen (e.g., length of illness, how complicated the regimen is), related to the medication (e.g., taste, side effects), related to their mind (e.g., memory problems, confusion), and related to their emotions (e.g., being depressed, anxious). The investigators will be looking at each regimen-related behavior, such as attending clinic appointments and will be asking each family about any barriers that make it difficult. The investigators hope that knowing these barriers will help them make interventions that fit the specific issues that each patient faces. Ultimately, doctors, transplant coordinators, and psychological professionals will be able to use this information to intervene early with families who report barriers that impact adherence.


Condition
Kidney Transplantation
Liver Transplantation
Heart Transplantation
Lung Transplantation
Heart-Lung Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Health Behaviors and Quality of Life in Pediatric Solid Organ Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Emory University:

Enrollment: 65
Study Start Date: May 2005
Estimated Study Completion Date: May 2014
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
pediatric solid organ transplants
Adherence to medical regimens refers to what degree a patient chooses to follow the advice given by his/her healthcare provider.More recently, researchers have started to look at adherence with children who have undergone solid organ transplantation. This is because about 50% of these children are to some degree non-adherent with their medical regimen. This comes at a costly price as ongoing non-adherence in pediatric transplant can lead to the child's body rejecting the new organ and even death. This study has been designed to look at the reasons that pediatric patients may choose to be non-adherent.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male or female Patients at Children's Healthcare of Atlanta Patients at least 11 years old and living at home for 6 months Solid organ transplant patients between 1.1.1988 and 12.31.2004

Criteria

Inclusion Criteria:

  • Solid organ transplant at Children's Healthcare of Atlanta (CHOA)
  • 11-18 years of age
  • Lives with the parents in the home
  • Signed informed consent

Exclusion Criteria:

  • Has not lived with parent for at least 6 months
  • Medical records are not accessible through the CHOA system
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209196

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Laura Mee, PhD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Laura L. Mee, Psychologist, Emory University
ClinicalTrials.gov Identifier: NCT00209196     History of Changes
Other Study ID Numbers: IRB00045836
Study First Received: September 14, 2005
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
pediatric
transplantation
psychosocial
kidney transplant recipient
liver transplant recipient
heart transplant recipient
lung transplant recipient
heart-lung transplant recipient

ClinicalTrials.gov processed this record on August 18, 2014