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Completed

NCT Number: NCT00485420

eCare for Moods: An Internet-based Management Program

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet based disease management program

Other

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

Other names: Care management via the internet

Primary outcomes

  1. Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms

    Time frame: Two years

Secondary outcomes

  1. Satisfaction with medical care

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Jun 13, 2007
Registry last updated
Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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