Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Not Applicable

Completed

• Conditions: Chronic Disease; Stroke
• Interventions: Behavioral: Chronic Disease Self-Management Program (CDSMP)

• Registration Number: NCT01770184
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-17
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Chronic Disease Self-Management Program (CDSMP)	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.

Primary Outcome Measures

Name	Time	Method
Adapted Illness Intrusiveness Ratings (AIIR)	Change from baseline to 6-months post-stroke
Healthcare Utilization Survey (HCUS)	Change from baseline to 6-months post-stroke

Secondary Outcome Measures

Name	Time	Method
Multidimensional Assessment of Fatigue (MAF)	Change from baseline to 6-months post-stroke
Stroke Impact Scale (SIS)	Change from baseline to 6-months post-stroke
Reintegration to Normal Living Index (RNLI)	Change from baseline to 6-months post-stroke
Patient Health Questionnaire (PHQ-9)	Change from baseline to 6-months post-stroke
Work Ability Index (WAI)	Change from baseline to 6-months post-stroke
World Health Organization Quality of Life (WHOQOL-BREF)	Change from baseline to 6-months post-stroke
Chronic Disease Self-Efficacy Scale (CDSES)	Change from baseline to 6-months post-stroke
Activity Card Sort (ACS)	Change from baseline to 6-months post-stroke

Trial Locations

Locations (1)

Washington University in St. Louis, School of Medicine, Program in Occupational Therapy; 🇺🇸 St. Louis, Missouri, United States