- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00312949
Effectiveness of an Interactive Educational Website for Improving the Quality of Mental Health Care for People With Schizophrenia
Consumer Internet Education About Mental Health Quality
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins Hospital
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- N/A
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Participants will use the interactive website
|
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.
|
|
Active Comparator: 2
Participants will read written materials and watch a video
|
Participants in the written materials/video group will be given the reading material and will watch a 20-minute video.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Concordance of treatment with evidence-based recommendations
Time Frame: Measured at Month 6
|
Measured at Month 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient engagement in dialogue with clinician about schizophrenia management issues
Time Frame: Measured at visit immediately following intervention/control condition
|
Measured at visit immediately following intervention/control condition
|
|
Clinician satisfaction with interaction with patient
Time Frame: Measured at visit immediately following intervention/control condition
|
Measured at visit immediately following intervention/control condition
|
|
Patient satisfaction with interaction with clinician
Time Frame: Measured at visit immediately following intervention/control condition and at Month 2 post-intervention
|
Measured at visit immediately following intervention/control condition and at Month 2 post-intervention
|
|
Symptoms of psychosis
Time Frame: Measured at Month 2 post-intervention
|
Measured at Month 2 post-intervention
|
|
Symptoms of depression
Time Frame: Measured at Month 2 post-intervention
|
Measured at Month 2 post-intervention
|
|
Quality of life ratings
Time Frame: Measured at Month 2 post-intervention
|
Measured at Month 2 post-intervention
|
|
Adherence to care regimen
Time Frame: Measured at Month 2 post-intervention
|
Measured at Month 2 post-intervention
|
|
Satisfaction with outcomes of care
Time Frame: Measured at Month 2 post-intervention
|
Measured at Month 2 post-intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Donald M. Steinwachs, PhD, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH067189 (U.S. NIH Grant/Contract)
- DSIR 82-SEDR
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.
Clinical Trials on Schizophrenia
-
Fundació Institut de Recerca de l'Hospital de la...Recruiting
-
First Affiliated Hospital of Fujian Medical UniversityNot yet recruiting
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Newron Pharmaceuticals SPARecruitingTreatment-resistant SchizophreniaUnited States
-
Bradley LegaRecruiting
-
Central Institute of Mental Health, MannheimRecruitingSchizophrenia | Treatment Resistant SchizophreniaGermany
-
All India Institute of Medical Sciences, BhubaneswarCompletedTreatment Resistant SchizophreniaIndia
-
Elazığ Mental Health and Diseases HospitalCompleted
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalCompletedSchizophrenia DisorderTurkey (Türkiye)
Clinical Trials on Interactive Website on management of schizophrenia
-
Lawson Health Research InstituteCompleted
-
Centre de Recherche de l'Institut Universitaire...Canadian Institutes of Health Research (CIHR); Brunel UniversityCompletedUrinary IncontinenceUnited Kingdom
-
Yan LuActive, not recruitingGestational Diabetes Mellitus | Early Nursing InterventionChina
-
Dartmouth-Hitchcock Medical CenterCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
University of Michigan Rogel Cancer CenterNational Cancer Institute (NCI)CompletedProstate CancerUnited States
-
University of BueaUniversity of California, Berkeley; University of California, Los Angeles; Fogarty...CompletedPost-traumatic Stress Disorder (PTSD) Among Road Traffic Injury VictimsCameroon
-
IRCCS San Raffaele RomaMinistero della Salute, ItalyRecruiting
-
Trakya UniversityCompletedQuality of Life | Rheumatoid Arthritis | Depression, Anxiety | Nurse's RoleTurkey
-
University Health Network, TorontoCompleted