- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00543257
Parents at the Center: Information Management in ADHD - Clinical Trial
October 4, 2017 updated by: Eugenia Chan, Boston Children's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
194
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Parents of school-age children with ADHD
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Parents will be asked to write down information specific to their child's ADHD using paper forms.
Parents will use a computer to complete data entry on information specific to their child's ADHD care
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Porter, MD, Boston Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
October 10, 2007
First Submitted That Met QC Criteria
October 10, 2007
First Posted (Estimate)
October 12, 2007
Study Record Updates
Last Update Posted (Actual)
October 6, 2017
Last Update Submitted That Met QC Criteria
October 4, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHB-R01LM009256
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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