Clinical Effectiveness of Self-Management Education Post-Mild Stroke

NCT01770184 | Completed

• 1 other identifier: 1K23HD073190-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Chronic Disease

Keywords

Self-management; Rehabilitation; Occupational Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Patient Health Questionnaire (PHQ-9)

  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

• World Health Organization Quality of Life (WHOQOL-BREF)

  Change from baseline to 6-months post-stroke

• Chronic Disease Self-Efficacy Scale (CDSES)

  Change from baseline to 6-months post-stroke

Study Arms (2)

Intervention Group

EXPERIMENTAL

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)

Usual Care Group

NO INTERVENTION

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.

Interventions

Chronic Disease Self-Management Program (CDSMP) BEHAVIORAL

Intervention Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a mild stroke as NIHSS total scores 0-5
• years of age
• English speaking
• identified as having at least one other chronic condition besides stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

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

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

• 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.

  PMID: 34813082 DERIVED

Related Links

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

MeSH Terms

Conditions

Stroke; Chronic Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Timothy J Wolf, OTD, MSCI, OTR/L

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 17, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

US (1)