Clinical trial NCT00543257: Parents at the Center: Information Management in ADHD - Clinical Trial
Official title: Parents at the Center: Information Management in ADHD - Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Literacy
Attention Deficit Disorder With Hyperactivity
Computer Literacy
Information Management
Parents
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2007-10-12
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of school-age children with ADHD

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Stephen Porter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.