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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543257
• Other study ID #: CHB-R01LM009256
• Status: Completed
• Phase: N/A
• First received: October 10, 2007
• Last updated: October 4, 2017
• Start date: December 2007
• Est. completion date: June 2014

Study information

• Verified date: October 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 2014
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Use of paper forms to write down information
Parents will be asked to write down information specific to their child's ADHD using paper forms.
• Computer
Parents will use a computer to complete data entry on information specific to their child's ADHD care

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	National Library of Medicine (NLM)

Country where clinical trial is conducted

United States,