eCare for Moods: An Internet-based Management Program
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Major Depressive Disorder Bipolar Disorder |
Other: Internet based disease management program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients |
- Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Satisfaction with medical care [ Time Frame: Two years ] [ Designated as safety issue: No ]
| Enrollment: | 404 |
| Study Start Date: | September 2002 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Usual Care
Member with recurrent or chronic depression receives usual specialty mental health care
|
Other: Internet based disease management program
Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
Other Name: Care management via the internet
|
|
Experimental: Internet-based disease managment program
Usual care is augmented with internet based education, self monitoring and clinical monitoring
|
Other: Internet based disease management program
Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
Other Name: Care management via the internet
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT00485420 History of Changes |
| Other Study ID Numbers: | CN-02EHunk-02-H |
| Study First Received: | June 11, 2007 |
| Last Updated: | April 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kaiser Permanente:
|
Internet based disease management program |
Additional relevant MeSH terms:
|
Bipolar Disorder Depressive Disorder Depression Depressive Disorder, Major |
Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013