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
  Purpose

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.


Condition Intervention
Stroke
Chronic Disease
Behavioral: Chronic Disease Self-Management Program (CDSMP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01770184

Contacts
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

Locations
United States, Missouri
Washington University in St. Louis, School of Medicine, Program in Occupational Therapy Recruiting
St. Louis, Missouri, United States, 63108
Contact: Timothy J Wolf, OTD, MSCI, OTR/L    314-286-1683    wolft@wusm.wustl.edu   
Principal Investigator: Timothy J Wolf, OTD, MSCI, OTR/L         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Timothy J Wolf, OTD, MSCI, OTR/L Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01770184     History of Changes
Other Study ID Numbers: 1K23HD073190-01
Study First Received: January 11, 2013
Last Updated: October 7, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Self-management
Rehabilitation
Occupational Therapy

Additional relevant MeSH terms:
Stroke
Chronic Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014