Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

This study is currently recruiting participants.

Verified November 2012 by National Institute of Allergy and Infectious Diseases (NIAID)

Sponsor:

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT01370746

First received: June 8, 2011

Last updated: November 14, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 8, 2011

Last Updated Date

November 14, 2012

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients [ Time Frame: 1 month post transplant ] [ Designated as safety issue: No ]
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)
Change in perceived barriers to adherence from baseline to follow-up [ Time Frame: 12 months post transplant ] [ Designated as safety issue: No ]
Barriers assessed using Brief Medication Questionnaire (BMQ); Adolescent Medication Barrier Scales questionnaire (AMBS); and Parent Medication Barriers Scale questionnaire (PMBS)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01370746 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation

Official Title ^ICMJE

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

Brief Summary

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. 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Adolescents and pediatric patients after solid organ transplantation (heart, liver, or lung)

Condition ^ICMJE

Organ Transplantation

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Cross-Sectional Study Group
Cross-sectional comparison of perceived barriers to adherence to post-transplant immunosuppressant regimens in parents/legal guardians of children 0-11 years versus adolescents 12-21 years
Longitudinal Study Group
Subset of Cross-Sectional Study Group to evaluate whether perceived barriers to adherence increase with time during the first year following transplantation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

April 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01370746

Other Study ID Numbers ^ICMJE

DAIT CTOTC-05

Has Data Monitoring Committee

Yes

Responsible Party

National Institute of Allergy and Infectious Diseases (NIAID)

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Stuart Sweet, MD, PhD	Washington University in St. Louis
Study Chair:	Lara Danziger-Isakov, MD, MPH	Children's Hospital Medical Center, Cincinnati

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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