Improving Depression Care for Elders: Coordinating Center | NCT01561105

Studies
Improving Depression Care for Elders: Coordinating Center

NCT01561105

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Mar 28, 2012Estimated

Enrollment

1,801Actual

Phase

Not Applicable

Conditions

Major Depression
Dysthymic Disorder
Both Major Depression and Dysthymic Disorder

Interventions

IMPACT

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

Mar 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

Jan 1999

Primary Completion Date

Jun 2004Actual

Completion Date

Jun 2004Actual

First Submitted Date

Mar 20, 2012

First Submission Date that Met QC Criteria

Mar 20, 2012

First Posted Date

Mar 22, 2012Estimated

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

Mar 26, 2012

Last Update Posted Date

Mar 28, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jurgen Unutzer, MD, MPH, Professor and Vice-Chair of Psychiatry, Psychiatry and Behavioral Sciences, University of WashingtonPrincipal Investigator

Lead Sponsor

University of California, Los AngelesOTHER

Collaborators

Name	Class
The John A. Hartford Foundation	OTHER
California HealthCare Foundation	OTHER
Hogg Foundation	UNKNOWN
Robert Wood Johnson Foundation

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

Purpose: To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment(IMPACT) collaborative care management program for late-life depression.

Detailed Description

This study tested an organized method of delivering care for late life depression in primary care. Specifically, the investigators evaluated the effectiveness of this intervention as compared to 'care as usual'. The investigators studied the effect of the intervention on clinical outcomes such as depressive symptoms, functional status, health related quality of life. They also determined the cost-effectiveness of the intervention compared to care as usual.

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

1,801Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IMPACT	Experimental		Other: IMPACT
Care as Usual	No Intervention	Patients received all depression care available to them as part of care as usual in the participating primary care clinics.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMPACT	Other	IMPACT is a collaborative care management program for late-life depression	IMPACT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Severity of depression symptoms	Severity measured by the 21-item Hopkins Symptom Checklist.

Secondary Outcomes

Measure	Description	Time Frame
Functioning	measured by the Sheehan Health-Related Functioning Index

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Major depression or dysthymia as diagnosed by a structured diagnostic interview.
Patient plans to receive primary care at the study clinic for the next year.

Exclusion Criteria:

Age under 60.
Current symptoms or history of psychosis or mania as determined by structured diagnostic interview.
Cognitive impairment as defined by a score less than 23 on a Mini Mental Status Examination.
Terminal illness - defined as having a life expectancy of less than 6 months.
Active alcohol abuse as determined by a screening interview.
High suicide risk as determined by current plan for suicide or a history of more than 3 prior suicide attempts in the past 10 years.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 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
Jurgen Unutzer, MD, MPH	University of Washington	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12472325	Result	Unutzer J, Katon W, Callahan CM, Williams JW Jr, Hunkeler E, Harpole L, Hoffing M, Della Penna RD, Noel PH, Lin EH, Arean PA, Hegel MT, Tang L, Belin TR, Oishi S, Langston C; IMPACT Investigators. Improving Mood-Promoting Access to Collaborative Treatment. Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. JAMA. 2002 Dec 11;288(22):2836-45. doi: 10.1001/jama.288.22.2836.
24367124

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D003865	Depressive Disorder, Major
D019263	Dysthymic Disorder