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Implementing Evidence in the Detection and Treatment of Post Stroke Depression

This study has been completed.
Sponsor:
Collaborators:
Richard L. Roudebush VA Medical Center
Malcom Randall VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00296140
First received: February 22, 2006
Last updated: September 8, 2017
Last verified: September 2017
  Purpose

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 Intervention
Mental Health Neurology Health Services Behavioral: self management of PSD symptoms Procedure: screening and treatment of PSD

Study Type: Interventional
Study Design: 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

Further study details as provided by VA Office of Research and Development:

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


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

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


Enrollment: 45
Actual Study Start Date: December 13, 2006
Study Completion Date: December 31, 2009
Primary Completion Date: June 30, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
self management of PSD symptoms Behavioral: self management of PSD symptoms
screening and treatment of PSD Procedure: screening and treatment of PSD

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00296140     History of Changes
Other Study ID Numbers: IMV 04-096
Study First Received: February 22, 2006
Last Updated: September 8, 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

ClinicalTrials.gov processed this record on September 21, 2017