Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Stroke Clinical Trial

Official title:

Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770184
• Other study ID #: 1K23HD073190-01
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: April 27, 2016
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Disease
• Stroke

Intervention

Behavioral:
• Chronic Disease Self-Management Program (CDSMP)

Locations

Country	Name	City	State
United States	Washington University in St. Louis, School of Medicine, Program in Occupational Therapy	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	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

External Links

•   Chronic Disease Self-Management Program (CDSMP)
•   Performance, Participation, and Neurorehabilitation Laboratory: Timothy J. Wolf, OTD, MSCI, OTR/L (PI)