Skip to main content
Clinical Trials/NCT00485420
NCT00485420
Completed
Not Applicable

Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients

Kaiser Permanente0 sites404 target enrollmentSeptember 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Kaiser Permanente
Enrollment
404
Primary Endpoint
Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The study aim is to explore the effect of a comprehensive Internet-based disease management program for bipolar disorder and recurrent or chronic major depression on clinical outcomes and satisfaction with care.

Detailed Description

This study is a randomized controlled trial that includes 404 subjects, 300 subjects with bipolar disorder and 104 subjects with recurrent or chronic major depressive disorder. The study subject diagnostic groups (bipolar and depressive) are separately randomized to either usual care or to eCare and the data collected from the two diagnostic groups are analyzed separately. All subjects randomized to the eCare intervention are assigned an eCare nurse care manager in addition to one year of access to an Internet-delivered care management and patient self-management program. While both diagnostic groups receive similar Internet-delivered services for depression, the subjects with bipolar disorder receive special services for bipolar disorder. All subjects randomized to usual care will receive their normal psychiatric care and do not have access to the website. Study subjects are followed for 24 months and outcome measurements are taken every six months by telephone interviewers blinded to treatment assignment. Specific measures include depression and mania symptoms, severity, adherence with medication, general health, functioning at work and at home, satisfaction with care, and confidence in coping with their disorder. The primary outcomes for patients with bipolar disorder are the severity of depression and the severity of mania over time. The primary outcome for patients with recurrent or chronic depression is the severity of depression over time. The hypothesis is that Internet-based care management will have a favorable effect on the burden of bipolar disorder and/or on recurrent/chronic depression over time.

Registry
clinicaltrials.gov
Start Date
September 2002
End Date
December 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of bipolar or recurrent major depressive disorder and access to a computer

Exclusion Criteria

  • No diagnosis of bipolar or recurrent major depressive disorder, no computer access

Outcomes

Primary Outcomes

Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms

Time Frame: Two years

Secondary Outcomes

  • Satisfaction with medical care(Two years)

Similar Trials