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

NCT00543257 | Completed

• 1 other identifier: CHB-R01LM009256
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Literacy; Attention Deficit Disorder With Hyperactivity; Computer Literacy; Information Management; Parents

Study Arms (1)

Parents

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.

Other: Use of paper forms to write down information; Other: Computer

Interventions

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.

Parents

Computer OTHER

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

Parents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents of school-age children with ADHD

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Library of Medicine (NLM): collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 21269990 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Stephen Porter, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant In Medicine

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 12, 2007
• Study Start: December 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2014
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (1)