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Clinical Trials/NCT00312949
NCT00312949CompletedNot Applicable

Consumer Internet Education About Mental Health Quality

Johns Hopkins Bloomberg School of Public Health4 sites in 1 country56 target enrollmentStarted: April 2006Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
56
Locations
4
Primary Endpoint
Concordance of treatment with evidence-based recommendations

Study Overview

Brief Summary

This study will evaluate the effectiveness of an interactive educational website in enhancing discussions about treatment issues and improving the quality of care for people with schizophrenia.

Detailed Description

Schizophrenia is a disabling mental disorder that causes hallucinations and delusions in those affected by it. Research has proven that certain treatment methods are more effective in treating schizophrenia than others. However, not everyone with schizophrenia responds to treatment in the same way, and not all physicians use the same treatment methods. Educating individuals with schizophrenia about all treatments available instead of only the treatments they are receiving may improve the quality of care and lead to better correlation between treatment and quality standards. This study will evaluate the effectiveness of an interactive educational website in enhancing discussions about treatment issues and improving the congruence between expected quality of treatment and treatment received among people with schizophrenia.

Participants in this open label study will be randomly assigned to either use the interactive website or read written materials and watch a video. All three sources will contain information about evidence-based treatment recommendations. Both groups will complete a brief interview before performing their assigned tasks. Upon completion of the interview, participants in the written materials/video group will be given the reading material and will watch a 20-minute video. Participants in the web-user group will sit with a laptop computer, answer questions about themselves and their treatment, receive feedback on care that may be inconsistent with current recommendations, and receive suggestions on how to discuss this with their physicians. Participants in clinical settings will be asked to allow their next clinician visit to be audiotaped to assess outcomes. A phone interview will be conducted with all participants 2 months following the intervention to assess treatment satisfaction and other outcomes. Medical records will be reviewed to collect treatment information 6 months before and after the intervention.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
None

Eligibility Criteria

Ages
13 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of schizophrenia
  • Able to read and write English
  • Scheduled to see a participating clinician at one of the study sites

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Concordance of treatment with evidence-based recommendations

Time Frame: Measured at Month 6

Secondary Outcomes

  • Patient engagement in dialogue with clinician about schizophrenia management issues(Measured at visit immediately following intervention/control condition)
  • Patient satisfaction with interaction with clinician(Measured at visit immediately following intervention/control condition and at Month 2 post-intervention)
  • Symptoms of psychosis(Measured at Month 2 post-intervention)
  • Clinician satisfaction with interaction with patient(Measured at visit immediately following intervention/control condition)
  • Symptoms of depression(Measured at Month 2 post-intervention)
  • Satisfaction with outcomes of care(Measured at Month 2 post-intervention)
  • Quality of life ratings(Measured at Month 2 post-intervention)
  • Adherence to care regimen(Measured at Month 2 post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Donald Steinwachs

Professor

Johns Hopkins Bloomberg School of Public Health

Study Sites (4)

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