eCare for Moods: An Internet-based Management Program

NCT ID: NCT00485420

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2009-12-31

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.

Conditions

Major Depressive Disorder; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

Member with recurrent or chronic depression receives usual specialty mental health care

Group Type: ACTIVE_COMPARATOR

Internet based disease management program

Intervention Type: OTHER

Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring

Internet-based disease managment program

Usual care is augmented with internet based education, self monitoring and clinical monitoring

Group Type: EXPERIMENTAL

Internet based disease management program

Intervention Type: OTHER

Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring

Interventions

Internet based disease management program

Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring

Intervention Type: OTHER

Other Intervention Names

Care management via the internet

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enid M Hunkeler, MA

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Division of Research

Other Identifiers

CN-02EHunk-02-H

Identifier Type: -

Identifier Source: org_study_id