Clinical Trials Logo
  1. Home
  2. Organ Transplantation
  3. NCT01370746
  4. Details
NCT01370746 Clinical Trial

Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

Organ Transplantation Clinical Trial

Official title:
Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation (CTOTC-05)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01370746
Other study ID # DAIT CTOTC-05
Secondary ID
Status Completed
Phase N/A
First received June 8, 2011
Last updated June 1, 2017
Start date April 2012
Est. completion date April 2014

Study information
Verified date June 2017
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this study, doctors will observe how and when pediatric patients who have received a solid organ transplant take their prescribed medication, and determining if there are reasons that keep these patients from taking all of their medicine.

Description:

Adhering to treatment regimens after solid organ transplantation is critical for the prevention of complications, including acute and chronic organ rejection. It is important to recognize the perceived barriers to following treatment regimens and identify ways to address these barriers early in the course of treatment.

Recruitment information / eligibility
Status Completed
Enrollment 502
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- Subject and/or guardian must be able to understand and provide informed consent/assent in English or Spanish

- Male or female primary solid organ transplant patients 0-21 years of age

- Recipients at least 1 month post-transplant hospital discharge

Exclusion Criteria:

- Inability or unwillingness of a participant or parent/guardian to give informed consent or comply with study protocol

- Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the questionnaires

- Re-transplant recipient

- Multi-organ transplant recipient

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Emory Children's Center Atlanta Georgia
United States University of Alabama Birmingham Alabama
United States Children's Hospital of Boston Boston Massachusetts
United States The Cleveland Clinic Cleveland Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States University of Florida Health Sciences Center Gainesville Florida
United States Baylor College of Medicine/Texas Children's Hospital Houston Texas
United States Ronald Reagan UCLA Medical Center (Mattel Childrens') Los Angeles California
United States Children's Hospital of New York New York New York
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States University of Pittsburgh School of Medicine Pittsburgh Pennsylvania
United States Washington University School of Medicine Saint Louis Missouri
United States University of California San Francisco Children's Hospital San Francisco California
United States Children's Hospital and Regional Medical Center Seattle Washington
United States Lucile Packard Children's Hospital at Stanford Stanford California

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trials in Organ Transplantation in Children

Country where clinical trial is conducted

United States, 

References & Publications (2)

Danziger-Isakov L, Frazier TW, Worley S, Williams N, Shellmer D, Dharnidharka VR, Gupta NA, Ikle D, Sweet SC; CTOTC-05 Consortium. Perceived barriers to medication adherence in pediatric and adolescent solid organ transplantation. Pediatr Transplant. 2016 — View Citation

Shemesh E. Barriers to adherence - To screen or not to screen, that is the question. Pediatr Transplant. 2016 Mar;20(2):188-90. doi: 10.1111/petr.12671. Epub 2016 Jan 22. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS) 1 month post transplant
Primary Change in perceived barriers to adherence from baseline to follow-up Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS) 12 months post transplant
See also
  Status Clinical Trial Phase
Recruiting NCT00987103 - Pharmacokinetic Study to Rectal and Sublingual Administration of Tacrolimus in Future Kidney Transplant Patients Phase 1
Completed NCT03699839 - Reducing the Burden of Influenza After Solid-Organ Transplantation Phase 2/Phase 3
Completed NCT01633424 - The "Stanford Integrated Psychosocial Assessment for Transplant" (SIPAT)
Completed NCT01254955 - Antibody Production Following H1N1 Influenza Vaccination in Organ Transplant Patients N/A
Completed NCT00948883 - Study of Cancers After Solid Organs Transplants N/A
Recruiting NCT02314949 - Leuven Tolerogenic Protocol for Intestinal Transplantation N/A
Recruiting NCT01283295 - Immune Monitoring and Assay Development in Organ Transplant Recipients
Not yet recruiting NCT03861962 - Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level
Completed NCT01123187 - Islet Cell Transplantation in Patients With Type I Diabetes With Previous Kidney Transplantation N/A
Completed NCT00213304 - The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation Phase 3
Completed NCT01515072 - Remote Ischemic Preconditioning in Neurological Death Organ Donors N/A
Completed NCT00904579 - Cancer Risk in Organ Transplant Recipients and End-Stage Renal Disease
Recruiting NCT04687865 - Constitution of a Biobank for Studies Related to Organ Transplantation (Lyon Centaure Biocollection)
Recruiting NCT00611494 - Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors Phase 4
Completed NCT02852902 - Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
Completed NCT05685888 - Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation
Recruiting NCT00792064 - Systematic Evaluation of Predictors of Quality of Life in the Long-term After Solid Organ Transplantation N/A
Completed NCT00734396 - Mesenchymal Stem Cells and Subclinical Rejection Phase 1/Phase 2
Completed NCT00286871 - Randomized Controlled Trial in Liver Transplant Recipients Treated in Steroid Sparing Regimen Phase 1
Recruiting NCT03997253 - Optimizing Long-term Survival in Organ Transplantation: From Physiopathology to Optimized Patient Management N/A

External Links