SchizophreniaNCT00312949
Effectiveness of an Interactive Educational Website for Improving the Quality of Mental Health Care for People With Schizophrenia
A study testing Interactive Website on management of schizophrenia and Written materials and video on management of schizophrenia in people with Schizophrenia, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Interactive Website on management of schizophrenia and Written materials and video on management of schizophrenia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia
- Able to read and write English
- Scheduled to see a participating clinician at one of the study sites
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Consumer Internet Education About Mental Health Quality
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Interactive Website on management of schizophrenia, Written materials and video on management of schizophrenia
- Keywords
- Patient participation, Patient education, Consumer involvement
- Medical subject headings
- Schizophrenia, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Website on management of schizophreniaBehavioural
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.
Written materials and video on management of schizophreniaBehavioural
Participants in the written materials/video group will be given the reading material and will watch a 20-minute video.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will use the interactive website Receives: Behavioral: Interactive Website on management of schizophrenia |
| 2 | Active comparator | Participants will read written materials and watch a video Receives: Behavioral: Written materials and video on management of schizophrenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of treatment with evidence-based recommendations
Measured: Measured at Month 6
Secondary outcomes (8)
Patient engagement in dialogue with clinician about schizophrenia management issues
Measured: Measured at visit immediately following intervention/control condition
Clinician satisfaction with interaction with patient
Measured: Measured at visit immediately following intervention/control condition
Patient satisfaction with interaction with clinician
Measured: Measured at visit immediately following intervention/control condition and at Month 2 post-intervention
Symptoms of psychosis
Measured: Measured at Month 2 post-intervention
Symptoms of depression
Measured: Measured at Month 2 post-intervention
Quality of life ratings
Measured: Measured at Month 2 post-intervention
Adherence to care regimen
Measured: Measured at Month 2 post-intervention
Satisfaction with outcomes of care
Measured: Measured at Month 2 post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionOct 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Donald Steinwachs, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Donald M. Steinwachs, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312949
- Sponsor's protocol ID
- R01MH067189
- Other IDs
- R01MH067189, DSIR 82-SEDR
- Status last verified
- Apr 2015
- First submitted
- 7 Apr 2006
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumer Internet Education About Mental Health Quality
- ClinicalTrials.gov ID
- NCT00312949
- Acronym / sponsor ID
- R01MH067189
- Conditions
- Schizophrenia
- Keywords
- Patient participation, Patient education, Consumer involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Interactive Website on management of schizophreniaParticipants will use the interactive website |
| 2 | Active comparator | Behavioral: Written materials and video on management of schizophreniaParticipants will read written materials and watch a video |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia
- Able to read and write English
- Scheduled to see a participating clinician at one of the study sites
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Website on management of schizophreniaParticipants 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. | Behavioural | 1 |
| Written materials and video on management of schizophreniaParticipants in the written materials/video group will be given the reading material and will watch a 20-minute video. | Behavioural | 2 |
Primary outcome
Concordance of treatment with evidence-based recommendations
Time frame: Measured at Month 6
8 secondary outcomes
Patient engagement in dialogue with clinician about schizophrenia management issues
Time frame: Measured at visit immediately following intervention/control condition
Clinician satisfaction with interaction with patient
Time frame: 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
Symptoms of psychosis
Time frame: Measured at Month 2 post-intervention
Symptoms of depression
Time frame: Measured at Month 2 post-intervention
Quality of life ratings
Time frame: Measured at Month 2 post-intervention
Adherence to care regimen
Time frame: Measured at Month 2 post-intervention
Satisfaction with outcomes of care
Time frame: Measured at Month 2 post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald M. Steinwachs, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Website on management of schizophrenia and Written materials and video on management of schizophrenia in people with Schizophrenia, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance of treatment with evidence-based recommendations (time frame: Measured at Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015; AzTrials last refreshed its copy on 29 Oct 2026.