Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Conditions
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Stroke, Chronic Disease

Intervention / Treatment
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* Behavioral: Chronic Disease Self-Management Program (CDSMP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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)<br> <br> |
| No Intervention: Usual Care Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Reintegration to Normal Living Index (RNLI) |  | 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 | 
| Multidimensional Assessment of Fatigue (MAF) |  | Change from baseline to 6-months post-stroke | 
| Activity Card Sort (ACS) |  | Change from baseline to 6-months post-stroke | 
| Stroke Impact Scale (SIS) |  | Change from baseline to 6-months post-stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Rehabilitation, Occupational Therapy