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Implementing Evidence in the Detection and Treatment of Post Stroke Depression

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ClinicalTrials.gov Identifier: NCT00296140
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : September 11, 2017
Sponsor:
Collaborators:
Richard L. Roudebush VA Medical Center
Malcom Randall VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease Intervention/treatment Phase
Mental Health Neurology Health Services Behavioral: self management of PSD symptoms Procedure: screening and treatment of PSD Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, randomized, outcome-blinded (PROBE) design. Intervention based on the Chronic Care Model
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implementation Evidence in the Detection and Treatment of Post-stroke Depression
Actual Study Start Date : December 13, 2006
Actual Primary Completion Date : June 30, 2009
Actual Study Completion Date : December 31, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
self management of PSD symptoms Behavioral: self management of PSD symptoms
screening and treatment of PSD Procedure: screening and treatment of PSD



Primary Outcome Measures :
  1. PHQ-9 [ Time Frame: 6 months ]
    Depression symptoms


Secondary Outcome Measures :
  1. SS-QOL [ Time Frame: 6 months ]
    Stroke-specific quality of life

  2. Self-efficacy [ Time Frame: 6 months ]
    Patient-reported self-efficacy for stroke symptom management



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296140


Locations
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608
United States, Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
VA Office of Research and Development
Richard L. Roudebush VA Medical Center
Malcom Randall VA Medical Center
Investigators
Principal Investigator: Linda S. Williams, MD Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Publication: Damush TM, Ofner S, Yu Z, Nicholas G, Williams LS. Implementation of a stroke self-management program. Translational Behavioral Medicine 2011;1:561-572

Publications of Results:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00296140     History of Changes
Other Study ID Numbers: IMV 04-096
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
post-stroke depression
clinical reminder
self-management

Additional relevant MeSH terms:
Depression
Behavioral Symptoms