Clinical Effectiveness of Self-Management Education Post-Mild Stroke

April 27, 2016 updated by: Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Washington University in St. Louis, School of Medicine, Program in Occupational Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: Chronic Disease Self-Management Program (CDSMP)
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adapted Illness Intrusiveness Ratings (AIIR)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke
Healthcare Utilization Survey (HCUS)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke
Work Ability Index (WAI)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke
Reintegration to Normal Living Index (RNLI)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke
World Health Organization Quality of Life (WHOQOL-BREF)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke
Chronic Disease Self-Efficacy Scale (CDSES)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke
Multidimensional Assessment of Fatigue (MAF)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke
Activity Card Sort (ACS)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke
Stroke Impact Scale (SIS)
Time Frame: Change from baseline to 6-months post-stroke
Change from baseline to 6-months post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (ESTIMATE)

January 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1K23HD073190-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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