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Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01770184
Enrollment
70
Registered
2013-01-17
Start date
2013-01-31
Completion date
2016-01-31
Last updated
2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Stroke

Keywords

Self-management, Rehabilitation, Occupational Therapy

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.

Interventions

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
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
World Health Organization Quality of Life (WHOQOL-BREF)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
Patient Health Questionnaire (PHQ-9)Change from baseline to 6-months post-stroke
Chronic Disease Self-Efficacy Scale (CDSES)Change from baseline to 6-months post-stroke

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026