eCare for Moods: An Internet-based Management Program
| Tracking Information | |||||
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| First Received Date ICMJE | June 11, 2007 | ||||
| Last Updated Date | April 18, 2012 | ||||
| Start Date ICMJE | September 2002 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Reduction of mania and depression symptoms and improved functioning [ Time Frame: Two years ] | ||||
| Change History | Complete list of historical versions of study NCT00485420 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Satisfaction with medical care [ Time Frame: Two years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Satisfaction with medical care [ Time Frame: Two years ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | eCare for Moods: An Internet-based Management Program | ||||
| Official Title ICMJE | Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 404 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00485420 | ||||
| Other Study ID Numbers ICMJE | CN-02EHunk-02-H | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kaiser Permanente | ||||
| Study Sponsor ICMJE | Kaiser Permanente | ||||
| Collaborators ICMJE | Eli Lilly and Company | ||||
| Investigators ICMJE |
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| Information Provided By | Kaiser Permanente | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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