eCare for Moods: An Internet-based Management Program

Major Depressive Disorder Clinical Trial

Official title:

Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485420
• Other study ID #: CN-02EHunk-02-H
• Status: Completed
• Phase: N/A
• First received: June 11, 2007
• Last updated: April 18, 2012
• Start date: September 2002
• Est. completion date: December 2009

Study information

• Verified date: April 2012
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Other:
• Internet based disease management program
Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Eli Lilly and Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms		Two years	No
Secondary	Satisfaction with medical care		Two years	No