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eCare for Moods: An Internet-based Management Program

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00485420
First received: June 11, 2007
Last updated: April 18, 2012
Last verified: April 2012

June 11, 2007
April 18, 2012
September 2002
September 2009   (final data collection date for primary outcome measure)
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 ]
Reduction of mania and depression symptoms and improved functioning [ Time Frame: Two years ]
Complete list of historical versions of study NCT00485420 on ClinicalTrials.gov Archive Site
Satisfaction with medical care [ Time Frame: Two years ] [ Designated as safety issue: No ]
Satisfaction with medical care [ Time Frame: Two years ]
Not Provided
Not Provided
 
eCare for Moods: An Internet-based Management Program
Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Major Depressive Disorder
  • Bipolar Disorder
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
  • Active Comparator: Usual Care
    Member with recurrent or chronic depression receives usual specialty mental health care
    Intervention: Other: Internet based disease management program
  • Experimental: Internet-based disease managment program
    Usual care is augmented with internet based education, self monitoring and clinical monitoring
    Intervention: Other: Internet based disease management program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
404
December 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00485420
CN-02EHunk-02-H
Yes
Kaiser Permanente
Kaiser Permanente
Eli Lilly and Company
Principal Investigator: Enid M Hunkeler, MA Kaiser Permanente Division of Research
Kaiser Permanente
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP