Effectiveness of an Interactive Educational Website for Improving the Quality of Mental Health Care for People With Schizophrenia
| Tracking Information | |||||
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| First Received Date ICMJE | April 7, 2006 | ||||
| Last Updated Date | February 29, 2008 | ||||
| Start Date ICMJE | April 2006 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Concordance of treatment with evidence-based recommendations [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Measured 6 months post-intervention: Concordance of treatment with evidence-based recommendations | ||||
| Change History | Complete list of historical versions of study NCT00312949 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of an Interactive Educational Website for Improving the Quality of Mental Health Care for People With Schizophrenia | ||||
| Official Title ICMJE | Consumer Internet Education About Mental Health Quality | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Schizophrenia | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 56 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 13 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00312949 | ||||
| Other Study ID Numbers ICMJE | R01 MH67189, DSIR 82-SEDR | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Donald M. Steinwachs, PhD, Johns Hopkins Bloomberg School of Public Health | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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