eCare for Moods: An Internet-based Management Program | NCT00485420

Studies
eCare for Moods: An Internet-based Management Program

NCT00485420

Sponsor

Kaiser Permanente

Status

Completed

Last Update Posted

Apr 19, 2012Estimated

Enrollment

404Actual

Phase

Not Applicable

Conditions

Major Depressive Disorder
Bipolar Disorder

Interventions

Internet based disease management program

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Sep 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jun 11, 2007

First Submission Date that Met QC Criteria

Jun 11, 2007

First Posted Date

Jun 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2012

Last Update Posted Date

Apr 19, 2012Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

404Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual Care	Active Comparator	Member with recurrent or chronic depression receives usual specialty mental health care	Other: Internet based disease management program
Internet-based disease managment program	Experimental	Usual care is augmented with internet based education, self monitoring and clinical monitoring	Other: Internet based disease management program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Internet based disease management program	Other	Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring	Internet-based disease managment program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms		Two years

Secondary Outcomes

Measure	Description	Time Frame
Satisfaction with medical care		Two years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Enid M Hunkeler, MA	Kaiser Permanente Division of Research	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided