Clinical trial NCT01770184: Clinical Effectiveness of Self-Management Education Post-Mild Stroke
Official title: Clinical Effectiveness of Self-Management Education Post-Mild Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Chronic Disease
Keywords: Self-management
Rehabilitation
Occupational Therapy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Adapted Illness Intrusiveness Ratings (AIIR)
timeFrame: Change from baseline to 6-months post-stroke
measure: Healthcare Utilization Survey (HCUS)
timeFrame: Change from baseline to 6-months post-stroke
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline to 6-months post-stroke
measure: Work Ability Index (WAI)
timeFrame: Change from baseline to 6-months post-stroke
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Change from baseline to 6-months post-stroke
measure: World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Change from baseline to 6-months post-stroke
measure: Chronic Disease Self-Efficacy Scale (CDSES)
timeFrame: Change from baseline to 6-months post-stroke
measure: Multidimensional Assessment of Fatigue (MAF)
timeFrame: Change from baseline to 6-months post-stroke
measure: Activity Card Sort (ACS)
timeFrame: Change from baseline to 6-months post-stroke
measure: Stroke Impact Scale (SIS)
timeFrame: Change from baseline to 6-months post-stroke
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University in St. Louis, School of Medicine, Program in Occupational Therapy
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Timothy J Wolf, OTD, MSCI, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.