Effectiveness of an Interactive Educational Website for Improving the Quality of Mental Health Care for People With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Donald Steinwachs, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00312949
First received: April 7, 2006
Last updated: April 15, 2015
Last verified: April 2015
  Purpose
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.

Condition Intervention
Schizophrenia
Behavioral: Interactive Website on management of schizophrenia
Behavioral: Written materials and video on management of schizophrenia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Consumer Internet Education About Mental Health Quality

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Concordance of treatment with evidence-based recommendations [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient engagement in dialogue with clinician about schizophrenia management issues [ Time Frame: Measured at visit immediately following intervention/control condition ] [ Designated as safety issue: No ]
  • Clinician satisfaction with interaction with patient [ Time Frame: Measured at visit immediately following intervention/control condition ] [ Designated as safety issue: No ]
  • Patient satisfaction with interaction with clinician [ Time Frame: Measured at visit immediately following intervention/control condition and at Month 2 post-intervention ] [ Designated as safety issue: No ]
  • Symptoms of psychosis [ Time Frame: Measured at Month 2 post-intervention ] [ Designated as safety issue: No ]
  • Symptoms of depression [ Time Frame: Measured at Month 2 post-intervention ] [ Designated as safety issue: No ]
  • Quality of life ratings [ Time Frame: Measured at Month 2 post-intervention ] [ Designated as safety issue: No ]
  • Adherence to care regimen [ Time Frame: Measured at Month 2 post-intervention ] [ Designated as safety issue: No ]
  • Satisfaction with outcomes of care [ Time Frame: Measured at Month 2 post-intervention ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: April 2006
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will use the interactive website
Behavioral: Interactive Website on management of schizophrenia
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
Behavioral: Written materials and video on management of schizophrenia
Participants in the written materials/video group will be given the reading material and will watch a 20-minute video.

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.

  Eligibility

Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312949

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Donald M. Steinwachs, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

Responsible Party: Donald Steinwachs, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00312949     History of Changes
Other Study ID Numbers: R01MH067189  DSIR 82-SEDR 
Study First Received: April 7, 2006
Last Updated: April 15, 2015
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Patient participation
Patient education
Consumer involvement

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 23, 2016