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Sponsor study identifier
observational
194
1 country
1
Study Start
December 2007
Actual (reported)Primary Completion
March 2009
Actual (reported)Study Completion
June 2014
Actual (reported)Health literacy is an integral part of the pathway for the successful transfer of information between patients and providers. Parents of children with Attention Deficit/ Hyperactivity Disorder (ADHD) play an essential role in chronic care as they offer critical information to providers that drives appropriate education and disease management. We propose the development and evaluation of an electronic data entry tool that enables parents to communicate data essential to treatment of their children, regardless of their own literacy skills. The research plan addresses a question central to patient-centered information management: how does health literacy influence parents' report of data on ADHD and the process-level events that result from parent-provider communication? The following specific aims organize the clinical study: proposal: 1) To assess the effect of health literacy on successful completion of parent-reported ADHD health information in both paper-based and PCHR formats, and, 2): To determine the association between health literacy and process-level outcomes for ADHD that stem from parent-provider exchange of information. The formal evaluation will study a diverse cohort of parents in a randomized trial of data entry (paper versus PCHR) for ADHD-specific information. Primary care records for children of this cohort will be analyzed for the prior 12 month period. Both a retrospective examination of documented ADHD processes of care and a prospective evaluation of the utility of data from the PCHR will occur. Literacy level is a primary variable of interest throughout the evaluation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2007
Actual (reported)October 12, 2007
Actual (reported)December 2007
Actual (reported)March 2009
Actual (reported)June 2014
Actual (reported)Parents of children with ADHD will be recruited from the greater Boston community. We are interested in enrollment of parents with a range of educational and technical backgrounds, and specifically will look to enroll parents who may not have much computer experience.
Parents will be asked to write down information specific to their child's ADHD using paper forms.
Parents will use a computer to complete data entry on information specific to their child's ADHD care
Parents of school-age children with ADHD
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Porter SC, Guo CY, Bacic J, Chan E. Health literacy and task environment influence parents' burden for data entry on child-specific health information: randomized controlled trial. J Med Internet Res. 2011 Jan 26;13(1):e13. doi: 10.2196/jmir.1612.
Stephen Porter, MD
Boston Children's Hospital
194 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2007
First Posted
October 12, 2007
Study Start
December 2007
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2009
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
October 6, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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