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Clinical Effectiveness of Self-Management Education Post-Mild Stroke

Primary Purpose

Stroke, Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic Disease Self-Management Program (CDSMP)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Self-management, Rehabilitation, Occupational Therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Usual Care Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adapted Illness Intrusiveness Ratings (AIIR)
Healthcare Utilization Survey (HCUS)

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9)
Work Ability Index (WAI)
Reintegration to Normal Living Index (RNLI)
World Health Organization Quality of Life (WHOQOL-BREF)
Chronic Disease Self-Efficacy Scale (CDSES)
Multidimensional Assessment of Fatigue (MAF)
Activity Card Sort (ACS)
Stroke Impact Scale (SIS)

Full Information

First Posted
January 11, 2013
Last Updated
April 27, 2016
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01770184
Brief Title
Clinical Effectiveness of Self-Management Education Post-Mild Stroke
Official Title
Clinical Effectiveness of Self-Management Education Post-Mild Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Chronic Disease
Keywords
Self-management, Rehabilitation, Occupational Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Chronic Disease Self-Management Program (CDSMP)
Primary Outcome Measure Information:
Title
Adapted Illness Intrusiveness Ratings (AIIR)
Time Frame
Change from baseline to 6-months post-stroke
Title
Healthcare Utilization Survey (HCUS)
Time Frame
Change from baseline to 6-months post-stroke
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Time Frame
Change from baseline to 6-months post-stroke
Title
Work Ability Index (WAI)
Time Frame
Change from baseline to 6-months post-stroke
Title
Reintegration to Normal Living Index (RNLI)
Time Frame
Change from baseline to 6-months post-stroke
Title
World Health Organization Quality of Life (WHOQOL-BREF)
Time Frame
Change from baseline to 6-months post-stroke
Title
Chronic Disease Self-Efficacy Scale (CDSES)
Time Frame
Change from baseline to 6-months post-stroke
Title
Multidimensional Assessment of Fatigue (MAF)
Time Frame
Change from baseline to 6-months post-stroke
Title
Activity Card Sort (ACS)
Time Frame
Change from baseline to 6-months post-stroke
Title
Stroke Impact Scale (SIS)
Time Frame
Change from baseline to 6-months post-stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J Wolf, OTD, MSCI, OTR/L
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis, School of Medicine, Program in Occupational Therapy
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34813082
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.
Results Reference
derived
Links:
URL
http://ot.wustl.edu/ot/otweb.nsf/6c18fc53358d390286256cde00604464/7f1c60fc33a21e2686257a8b0056d6f5?OpenDocument
Description
Performance, Participation, and Neurorehabilitation Laboratory: Timothy J. Wolf, OTD, MSCI, OTR/L (PI)

Learn more about this trial

Clinical Effectiveness of Self-Management Education Post-Mild Stroke

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