Clinical Effectiveness of Self-Management Education Post-Mild Stroke

NCT ID: NCT01770184

Last Updated: 2016-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Chronic Disease Self-Management Program (CDSMP)

Intervention Type BEHAVIORAL

Usual Care Group

The usual care group for this study will receive the rehabilitation services and support that is recommended and provided in the current health care structure. No additional intervention will be provided to the usual care group within this study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chronic Disease Self-Management Program (CDSMP)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy J Wolf, OTD, MSCI, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34813082 (View on PubMed)

Related Links

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http://ot.wustl.edu/ot/otweb.nsf/6c18fc53358d390286256cde00604464/7f1c60fc33a21e2686257a8b0056d6f5?OpenDocument

Performance, Participation, and Neurorehabilitation Laboratory: Timothy J. Wolf, OTD, MSCI, OTR/L (PI)

Other Identifiers

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1K23HD073190-01

Identifier Type: NIH

Identifier Source: org_study_id

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