Clinical Effectiveness of Self-Management Education Post-Mild Stroke

The Washington University

Status: Completed

Conditions: Chronic Disease; Stroke

Treatments: Behavioral: Chronic Disease Self-Management Program (CDSMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01770184

1K23HD073190-01

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Intervention Group

Experimental group

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.

Treatment:

Behavioral: Chronic Disease Self-Management Program (CDSMP)

Usual Care Group

No Intervention group

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.