Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-25 @ 4:20 AM
NCT ID:
NCT00485420
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.
Study:
NCT00485420
Study Brief:
Protocol Section:
NCT00485420