Feasibility of a Stroke Specific Self-management Program

Study Overview
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Brief Summary
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Stroke is a leading cause of disability, institutionalization, readmission and death. This research is being completed to accelerate the adoption of evidence-based therapy practices that improve overall stroke care and outcomes. We will implement a feasibility randomized controlled trial (RCT) studying the implementation of a stroke specific chronic disease self-management program. Specifically, if the person is identified to have a chronic vision impairment identified on the vision screen, a specific low vision self-management program will be used. Otherwise the program that will be used is the generic chronic disease self-management program.

Detailed Description
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Approximately 75% of people are living with a prevalent chronic disease like diabetes or hypertension. Despite this high percentage, there is a projected increase of 37% by 2030. There are approximately 795,000 people sustaining a stroke each year, in the United States. Surviving a stroke can cost an estimated $34 billion dollars a year in medical costs and loss of productivity. While there is a sharp decline in mortality rate following stroke, the rate of long-term residual impairments, disabilities and risk for developing high rates of secondary chronic conditions remains high. People living with a new stroke can also have chronic conditions in their past medical histories. Management of prior and new conditions may not become evident until the stroke survivor has returned to the community and are no longer receiving medical services. Additionally, management of chronic conditions, especially for people who now are recovering from a stroke, may require different management plans altogether. The Center for Disease Control and Prevention called for a public health action to address chronic illness. One type of community rehabilitation intervention method is self-management. Self-management was first developed for well-elderly with chronic diseases. These programs support individuals managing their independently managing symptoms as well as help with the emotional and physical stress associated with chronic disease. Multiple research reports conclude that self-management interventions improve health outcomes, help with management of self-identity and reduce health care costs. There are existing stroke specific self-management programs, however minimal reported research regarding the best way to implement and measure a stroke specific chronic disease self-management program to optimize health outcomes and improve quality of life. Recently, a qualitative study concluded that any stroke specific self-management program should include 3 conceptual layers to address individual, external and environmental factors essential to enable successful implementation. The first conceptual layer is individual capacity or readiness to respond to the demands to self-management. The second is having external support for self-management. And the third is being in an environment that supports and facilitates success. Another study reported strong feasibility evidence for stroke specific self-management programs versus a standard program for community dwelling stroke survivors. A small study reported a program administered to stroke patients that led to changes in self-efficacy. Consistent with a feasibility study for implementing evidence based intervention, this project intends to address a need to bridge the translation gap between research evidence and clinical practice. This project intends to provide information to add to existing literature regarding implementation. Thus we plan to use the Determinant Framework, which will help specify determinants which act as barriers and enablers that influence implementation outcomes. Additionally, implementation theories will help us assess the implementation context, as we plan to use a checklist to evaluate factors influencing implementation across different domains (e.g. fidelity). This study also intends to provide preliminary data regarding efficacy in order to determine if a stroke specific program was superior to standard care.

Official Title
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Feasibility of a Stroke Specific Self-management Program

Conditions
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Stroke, Chronic Conditions

Intervention / Treatment
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* Other: Self- management program
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute hospitalization due to diagnosis of stroke at least one chronic medical condition must be able to consent independently be alert and oriented x 3 be ≥ 18 years old Exclusion Criteria: unable to independently consent they do not speak English discharged from acute care to nursing home

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard Care<br>The standard care group will receive baseline testing #1, standard care, baseline testing #2 and follow up testing approximately 8 weeks later. | Other: Standard care<br>* All stroke patients being discharged from the acute hospital receive the following care: 1 follow-up call within 2 weeks by a nurse coordinator. The call involves checking if medications were able to be filled and how the person is feeling. A stroke clinic appointment that is set to occur 90-days post discharge. A list of their personal medications and generic educational materials. The educational materials are standard forms located in the Epic system. It is the nurses' responsibility to choose what forms to provide, however it is mandatory that stroke risk factor information is included. Information on local support groups. Referrals to start physical, occupational or speech therapy, if recommended by their physician.<br>|
| Experimental: Experimental<br>Experimental group will baseline testing #1, standard care, baseline testing #2 however then participate in a 6-week self-management intervention (either generic or vision specific self-management based) and then get 8 week follow up testing. | Other: Self- management program<br>* The program sessions are either adapted from the Stanford Patient Education Research Center's program called the Chronic Disease Self-Management Program (CDSMP) or from a vision self-management program. Despite which self-management program, the format for each session will include, review of educational materials (using the CDSMP book/article), discussion via a case vignette (which is always stroke related), and participation in an activity based on that session's topic. These group sessions will be 1.5 hours each week for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Patients Screened | number of patients screened | Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) | 
| Feasibility: Eligible Patients | number of patients eligible | Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) | 
| Feasibility: Patients Approached | number of patients approached | Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) | 
| Feasibility: Patients Enrolled | number of patients enrolled | Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) | 
| Feasibility: Patient Refusals | number of patient refusals | Collected at follow-up (2 weeks from last day of intervention) | 
| Feasibility: Patient Withdrawals | number of patient withdrawals | Collected at follow-up (2 weeks from last day of intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire | patient-reported outcome measure (PROM) of self-management competency following stroke, likert scale 1-6, higher scores on the scale equal less self-management skills | change in self- management from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months) | 
| Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire | patient-reported outcome measure (PROM) of self-management competency following stroke, likert scale 1-6, higher scores on the scale equal less self-management skills | change in self-management from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) | 
| Change in self-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale | Self-Efficacy for Managing: Daily Activities, Symptoms, Medications and Treatments, Emotions, and Social Interactions. Likert scale 1-5, higher scores on the scale equal better confidence | change in self-efficacy from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months) | 
| Change in self-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale | Self-Efficacy for Managing: Daily Activities, Symptoms, Medications and Treatments, Emotions, and Social Interactions. Likert scale 1-5, higher scores on the scale equal better confidence | change in self-efficacy from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) | 
| Change in self-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments | qualitative aspects of sleep and wake function via Likert scale of 1-5, higher scores on the scale equal better sleep | change in sleep from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months) | 
| Change in self-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments | qualitative aspects of sleep and wake function via Likert scale of 1-5, higher scores on the scale equal better sleep | change in sleep from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) | 
| Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25 | vision quality of life, likert scale 1-5, higher scores on the scale equal better visual function | change in vision quality of life from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months) | 
| Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25 | vision quality of life, likert scale 1-5, higher scores on the scale equal better visual function | change in vision quality of life from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) |