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

NCT ID: NCT00543257

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

194 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Use of paper forms to write down information

Intervention Type OTHER

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

Computer

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Computer

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Library of Medicine (NLM)

NIH

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eugenia Chan

Assistant In Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen Porter, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21269990 (View on PubMed)

Other Identifiers

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CHB-R01LM009256

Identifier Type: -

Identifier Source: org_study_id