NCT00029172

Brief Summary

The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P25-P50 for phase_4 stroke

Timeline
Completed

Started May 1999

Longer than P75 for phase_4 stroke

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2002

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

January 28, 2010

Completed
Last Updated

February 16, 2023

Status Verified

December 1, 2009

First QC Date

January 8, 2002

Results QC Date

August 3, 2009

Last Update Submit

January 19, 2023

Conditions

Keywords

strokedepression

Outcome Measures

Primary Outcomes (1)

  • Twelve Week Depression Outcomes

    Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%. The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale.

    Twelve week

Study Arms (1)

Nurse Case management

EXPERIMENTAL
Other: case management

Interventions

Nurse Case management

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* No severe language or cognitive deficits, * life expectancy of at least 9 months, and * willingness to participate.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Indiana University Hospital, 550 N. University Blvd.

Indianapolis, Indiana, 46202, United States

Location

Methodist Hospital of Indiana, 1601 N. Capitol

Indianapolis, Indiana, 46202, United States

Location

Roudebush VA Medical Center, Health Services Research and Development 11H, 1481 W. 10th Street

Indianapolis, Indiana, 46202, United States

Location

Wishard Memorial Hospital, 1001 W. 10th Street

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

  • Williams LS, Brizendine EJ, Plue L, Bakas T, Tu W, Hendrie H, Kroenke K. Performance of the PHQ-9 as a screening tool for depression after stroke. Stroke. 2005 Mar;36(3):635-8. doi: 10.1161/01.STR.0000155688.18207.33. Epub 2005 Jan 27.

    PMID: 15677576BACKGROUND
  • Williams LS, Bakas T, Brizendine E, Plue L, Tu W, Hendrie H, Kroenke K. How valid are family proxy assessments of stroke patients' health-related quality of life? Stroke. 2006 Aug;37(8):2081-5. doi: 10.1161/01.STR.0000230583.10311.9f. Epub 2006 Jun 29.

    PMID: 16809575BACKGROUND
  • Williams LS, Kroenke K, Bakas T, Plue LD, Brizendine E, Tu W, Hendrie H. Care management of poststroke depression: a randomized, controlled trial. Stroke. 2007 Mar;38(3):998-1003. doi: 10.1161/01.STR.0000257319.14023.61. Epub 2007 Feb 15.

MeSH Terms

Conditions

StrokeDepression

Interventions

Case Management

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Results Point of Contact

Title
Dr. Linda Williams
Organization
Roudebush VAMC Center of Excellence

Study Officials

  • Linda Williams, M.D.

    Roudebush VA Medical Center Health Services Research and Development 11H

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2002

First Posted

January 9, 2002

Study Start

May 1, 1999

Study Completion

December 1, 2005

Last Updated

February 16, 2023

Results First Posted

January 28, 2010

Record last verified: 2009-12

Locations