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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 November 2012 |
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Main ID: |
NCT01370746 |
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Date of registration:
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08/06/2011 |
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Primary sponsor: |
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Public title:
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Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation
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Scientific title:
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Perceived Barriers to Patient Adherence After Pediatric Solid Organ Transplantation (CTOTC-05) |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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400 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01370746 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Lara Danziger-Isakov, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Medical Center, Cincinnati |
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Name:
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Stuart Sweet, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University in St. Louis |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
21 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Organ Transplantation
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Primary Outcome(s)
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Change in perceived barriers to adherence from baseline to follow-up
[Time Frame: 12 months post transplant]
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Perceived barriers to adherence in adolescents and parent/legal guardian of pediatric patients
[Time Frame: 1 month post transplant]
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Secondary ID(s)
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DAIT CTOTC-05
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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