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Completed

NCT Number: NCT00543257

Parents at the Center: Information Management in ADHD - Clinical Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary language of parent/guardian is English or Spanish
  • Parent/guardian reports that child has been diagnosed with ADHD
  • Current child age is between 5 years and 12 years
  • Child in question resides with the parental subject primarily
  • Parent/guardian reports that they are the primary caretaker of the child
  • Parent/guardian reports that they are the person who communicates with the primary care provider
  • Parent/guardian reports that child is currently taking medication for ADHD or has taken it within the last 3 months

Exclusion criteria

  • Parent reports that child in question has been diagnosed with mental retardation, autism, pervasive developmental disorder, Aspergers, or bipolar disorder

Treatment and study plan

Use of paper forms to write down information

Other

Parents will be asked to write down information specific to their child's ADHD using paper forms.

Computer

Other

Parents will use a computer to complete data entry on information specific to their child's ADHD care

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • National Library of Medicine (NLM)

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2014
First posted
Oct 12, 2007
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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