Quality of Life in Pediatric Transplant Recipients

NCT00209196 | Completed

• 1 other identifier: IRB00045836
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplantation; Liver Transplantation; Heart Transplantation; Lung Transplantation; Heart-Lung Transplantation

Keywords

pediatric; transplantation; psychosocial; kidney transplant recipient; liver transplant recipient; heart transplant recipient; lung transplant recipient; heart-lung transplant recipient

Outcome Measures

Primary Outcomes (1)

• Pediatric Quality of Life Measure (Peds QL)

  paper questionaire

  up to one year

Study Arms (1)

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.

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• Has not lived with parent for at least 6 months
• Medical records are not accessible through the CHOA system

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Study Officials

• Laura Mee, PhD

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: January 1, 2015
• Last Updated: February 11, 2015

Record last verified: 2015-02

Locations

US (1)