NCT00312949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2006

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1.5 years

First QC Date

April 7, 2006

Last Update Submit

April 15, 2015

Conditions

Schizophrenia

Keywords

Patient participationPatient educationConsumer involvement

Outcome Measures

Primary Outcomes (1)

  • Concordance of treatment with evidence-based recommendations

    Measured at Month 6

Secondary Outcomes (8)

  • Patient engagement in dialogue with clinician about schizophrenia management issues

    Measured at visit immediately following intervention/control condition

  • Clinician satisfaction with interaction with patient

    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

  • Symptoms of depression

    Measured at Month 2 post-intervention

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Participants will use the interactive website

Behavioral: Interactive Website on management of schizophrenia

2

ACTIVE COMPARATOR

Participants will read written materials and watch a video

Behavioral: Written materials and video on management of schizophrenia

Interventions

Interactive Website on management of schizophreniaBEHAVIORAL

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.

1
Written materials and video on management of schizophreniaBEHAVIORAL

Participants in the written materials/video group will be given the reading material and will watch a 20-minute video.

2

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

SchizophreniaPatient Participation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Donald M. Steinwachs, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 11, 2006

Study Start

April 1, 2006

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

US(2)