Clinical Effectiveness of Self-Management Education Post-Mild Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01770184
First received: January 11, 2013
Last updated: October 7, 2013
Last verified: October 2013

January 11, 2013
October 7, 2013
January 2013
January 2016   (final data collection date for primary outcome measure)
  • Adapted Illness Intrusiveness Ratings (AIIR) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
  • Healthcare Utilization Survey (HCUS) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01770184 on ClinicalTrials.gov Archive Site
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
  • Work Ability Index (WAI) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
  • Reintegration to Normal Living Index (RNLI) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
  • World Health Organization Quality of Life (WHOQOL-BREF) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
  • Chronic Disease Self-Efficacy Scale (CDSES) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
  • Multidimensional Assessment of Fatigue (MAF) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
  • Activity Card Sort (ACS) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
  • Stroke Impact Scale (SIS) [ Time Frame: Change from baseline to 6-months post-stroke ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Effectiveness of Self-Management Education Post-Mild Stroke
Not Provided

Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10 years which is in large part due to the cyclical relationship of chronic disease, poor health, and mild stroke which has gone largely unnoticed in the United States. Self-management intervention has been proven to be an effective intervention to increase healthy behaviors, improve overall health status, decrease healthcare utilization/cost, decrease depressive symptoms, and improve participation in people with a variety of chronic conditions; however, it has never be used with individuals with mild stroke. The critical next step and goal of this study is to evaluate if self-management intervention will improve health outcomes for persons with mild stroke. The overall hypothesis of this study is that self-management intervention will improve outcomes in the mild-stroke population.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Chronic Disease
Behavioral: Chronic Disease Self-Management Program (CDSMP)
  • Experimental: Intervention Group
    The intervention group will receive the rehabilitation services and support that is recommended and provided in the current health care structure. The intervention group will also receive the Chronic Disease Self-Management Program (CDSMP). The CDSMP is an education program based on the concept of self-management. Self-management refers to the ability of an individual to manage the day-to-day responsibilities of living with a chronic condition. The CDSMP will be delivered in two and a half hour sessions, once a week, for six weeks, in group format.
    Intervention: Behavioral: Chronic Disease Self-Management Program (CDSMP)
  • No Intervention: Usual Care Group
    The usual care group for this study will receive the rehabilitation services and support that is recommended and provided in the current health care structure. No additional intervention will be provided to the usual care group within this study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2016
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • a mild stroke as NIHSS total scores 0-5
  • 18-90 years of age
  • English speaking
  • identified as having at least one other chronic condition besides stroke

Exclusion Criteria:

  • severe aphasia (NIHSS aphasia score=2)
  • moderate to severe cognitive impairment (MOCA < 21)
  • history of dementia
  • hemorrhagic stroke
  • neurological diagnoses other than stroke
  • major psychiatric illness (A diagnosis of bipolar disorder, obsessive compulsive disorder, panic disorder, schizophrenia, post-traumatic stress disorder, and borderline personality disorder)
  • a score of no-higher than 20 on the PHQ-9 indicating significant depressive symptoms
  • terminal illness
Both
18 Years to 90 Years
No
Contact: Timothy J Wolf, OTD, MSCI, OTR/L 314-286-1683 wolft@wusm.wustl.edu
Contact: Meghan Doherty, MSOT, OTR/L 314-454-8285 dohertyme@wusm.wustl.edu
United States
 
NCT01770184
1K23HD073190-01
No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Timothy J Wolf, OTD, MSCI, OTR/L Washington University School of Medicine
Washington University School of Medicine
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP