Back to resultseCare for Moods: An Internet-based Management Program
Primary Purpose
Major Depressive Disorder, Bipolar Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet based disease management program
Sponsored by
About this trial
This is an interventional health services research trial for Major Depressive Disorder focused on measuring Internet based disease management program
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual Care
Internet-based disease managment program
Arm Description
Member with recurrent or chronic depression receives usual specialty mental health care
Usual care is augmented with internet based education, self monitoring and clinical monitoring
Outcomes
Primary Outcome Measures
Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms
Secondary Outcome Measures
Satisfaction with medical care
Full Information
NCT ID
NCT00485420
First Posted
June 11, 2007
Last Updated
April 18, 2012
Sponsor
Kaiser Permanente
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00485420
Brief Title
eCare for Moods: An Internet-based Management Program
Official Title
Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Bipolar Disorder
Keywords
Internet based disease management program
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
404 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Member with recurrent or chronic depression receives usual specialty mental health care
Arm Title
Internet-based disease managment program
Arm Type
Experimental
Arm Description
Usual care is augmented with internet based education, self monitoring and clinical monitoring
Intervention Type
Other
Intervention Name(s)
Internet based disease management program
Other Intervention Name(s)
Care management via the internet
Intervention Description
Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
Primary Outcome Measure Information:
Title
Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Satisfaction with medical care
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enid M Hunkeler, MA
Organizational Affiliation
Kaiser Permanente Division of Research
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
eCare for Moods: An Internet-based Management Program
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