NCT00296140

Brief Summary

Post Stroke Depression (PSD)is a high volume condition with negative impact on patient recovery after stroke. The primary aim of this study is to evaluate the effectiveness of a system intervention to improve the proportion of Veterans screened and started on treatment for PSD. The secondary aim is evaluate whether a patient-based self-management intervention provides any additional benefit compared to usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

February 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2006

Completed
10 months until next milestone

Study Start

First participant enrolled

December 13, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2009

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

August 28, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

February 22, 2006

Results QC Date

November 15, 2017

Last Update Submit

August 24, 2018

Conditions

Mental HealthNeurologyHealth Services

Keywords

post-stroke depressionclinical reminderself-management

Outcome Measures

Primary Outcomes (1)

  • PHQ-9

    Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms

    6 months

Secondary Outcomes (2)

  • SS-QOL

    6 months

  • Self-efficacy

    6 months

Study Arms (2)

self management of PSD symptoms

OTHER
Behavioral: self management of PSD symptoms

screening and treatment of PSD

OTHER
Procedure: screening and treatment of PSD

Interventions

self management of PSD symptomsBEHAVIORAL
self management of PSD symptoms
screening and treatment of PSDPROCEDURE
screening and treatment of PSD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aim 1 - veterans with ischemic stroke hospitalized at any of the VISN 8 or 11 facilities during the 18th month enrollment period.
  • Aim 2 - veterans hospitalized at the Indianapolis or Gainesville VAMC's.

You may not qualify if:

  • Aim 1 - none
  • Aim 2 - 18 or younger, unable to speak or understand English, severe cognitive impairments, no access to telephone, not willing to follow-up at VA for outpatient care, unwilling to participate in interviews and/or life expectancy less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (2)

  • Damush TM, Plue L, Bakas T, Schmid A, Williams LS. Barriers and facilitators to exercise among stroke survivors. Rehabil Nurs. 2007 Nov-Dec;32(6):253-60, 262. doi: 10.1002/j.2048-7940.2007.tb00183.x.

    PMID: 18065147RESULT

  • Damush TM, Jackson GL, Powers BJ, Bosworth HB, Cheng E, Anderson J, Guihan M, LaVela S, Rajan S, Plue L. Implementing evidence-based patient self-management programs in the Veterans Health Administration: perspectives on delivery system design considerations. J Gen Intern Med. 2010 Jan;25 Suppl 1(Suppl 1):68-71. doi: 10.1007/s11606-009-1123-5.

    PMID: 20077155RESULT

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Results Point of Contact

Title
Dr. Linda Williams
Organization
Roudebush VA Medical Center
Linda.Williams6@va.gov
317-988-2715

Study Officials

  • Linda S. Williams, MD

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, outcome-blinded (PROBE) design. Intervention based on the Chronic Care Model
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2006

First Posted

February 24, 2006

Study Start

December 13, 2006

Primary Completion

June 30, 2009

Study Completion

December 31, 2009

Last Updated

August 28, 2018

Results First Posted

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Clinical Study Report Access

Locations

US(2)