Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Chronic Disease Self-Management Program (CDSMP) Behavioral
    ARM 1: Kind: Experimental
    Label: Intervention Group
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Adapted Illness Intrusiveness Ratings (AIIR) Change from baseline to 6-months post-stroke No
Primary Healthcare Utilization Survey (HCUS) Change from baseline to 6-months post-stroke No
Secondary Patient Health Questionnaire (PHQ-9) Change from baseline to 6-months post-stroke No
Secondary Work Ability Index (WAI) Change from baseline to 6-months post-stroke No
Secondary Reintegration to Normal Living Index (RNLI) Change from baseline to 6-months post-stroke No
Secondary World Health Organization Quality of Life (WHOQOL-BREF) Change from baseline to 6-months post-stroke No
Secondary Chronic Disease Self-Efficacy Scale (CDSES) Change from baseline to 6-months post-stroke No
Secondary Multidimensional Assessment of Fatigue (MAF) Change from baseline to 6-months post-stroke No
Secondary Activity Card Sort (ACS) Change from baseline to 6-months post-stroke No
Secondary Stroke Impact Scale (SIS) Change from baseline to 6-months post-stroke No

Sponsors