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Completed

NCT Number: NCT01770184

Clinical Effectiveness of Self-Management Education Post-Mild Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Disease Attributes Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis, School of Medicine, Program in Occupational Therapy

St Louis, Missouri, 63108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chronic Disease Self-management Program (CDSMP)

Behavioral

Primary outcomes

  1. Adapted Illness Intrusiveness Ratings (AIIR)

    Time frame: Change from baseline to 6-months post-stroke

  2. Healthcare Utilization Survey (HCUS)

    Time frame: Change from baseline to 6-months post-stroke

Secondary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: Change from baseline to 6-months post-stroke

  2. Work Ability Index (WAI)

    Time frame: Change from baseline to 6-months post-stroke

  3. Reintegration to Normal Living Index (RNLI)

    Time frame: Change from baseline to 6-months post-stroke

  4. World Health Organization Quality of Life (WHOQOL-BREF)

    Time frame: Change from baseline to 6-months post-stroke

  5. Chronic Disease Self-Efficacy Scale (CDSES)

    Time frame: Change from baseline to 6-months post-stroke

  6. Multidimensional Assessment of Fatigue (MAF)

    Time frame: Change from baseline to 6-months post-stroke

  7. Activity Card Sort (ACS)

    Time frame: Change from baseline to 6-months post-stroke

  8. Stroke Impact Scale (SIS)

    Time frame: Change from baseline to 6-months post-stroke

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 17, 2013
Registry last updated
Apr 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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