Parents at the Center: Information Management in ADHD - Clinical Trial
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Health Literacy Attention Deficit Disorder With Hyperactivity Computer Literacy Information Management Parents |
Other: Use of paper forms to write down information Other: Computer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Parents at the Center: Information Management in ADHD - Clinical Trial |
| Estimated Enrollment: | 224 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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.
Other: Computer
Parents will use a computer to complete data entry on information specific to their child's ADHD care
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Parents of school-age children with ADHD
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
Contacts and Locations| United States, Massachusetts | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Stephen Porter, MD | Children's Hospital Boston |
More Information
No publications provided by Children's Hospital Boston
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Stephen C Porter/ Assistant Professor, Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00543257 History of Changes |
| Other Study ID Numbers: | CHB-R01LM009256 |
| Study First Received: | October 10, 2007 |
| Last Updated: | March 26, 2009 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013