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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00543257
Other study ID # CHB-R01LM009256
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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, 

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