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出境医 / 临床实验 / Feasibility of a Stroke Specific Self-management Program

Feasibility of a Stroke Specific Self-management Program

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Chronic Conditions Other: Self- management program Other: Standard care Not Applicable

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Feasibility of a Stroke Specific Self-management Program
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : September 30, 2022
Arms and Interventions
Arm Intervention/treatment
Standard Care
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

All stroke patients being discharged from the acute hospital receive the following care:

  1. 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.
  2. A stroke clinic appointment that is set to occur 90-days post discharge.
  3. 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.
  4. Information on local support groups.
  5. Referrals to start physical, occupational or speech therapy, if recommended by their physician.
Experimental: Experimental
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

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
Outcome Measures
Primary Outcome Measures :
  1. Feasibility: Patients Screened [ Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) ]
    number of patients screened

  2. Feasibility: Eligible Patients [ Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) ]
    number of patients eligible

  3. Feasibility: Patients Approached [ Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) ]
    number of patients approached

  4. Feasibility: Patients Enrolled [ Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) ]
    number of patients enrolled

  5. Feasibility: Patient Refusals [ Time Frame: Collected at follow-up (2 weeks from last day of intervention) ]
    number of patient refusals

  6. Feasibility: Patient Withdrawals [ Time Frame: Collected at follow-up (2 weeks from last day of intervention) ]
    number of patient withdrawals


Secondary Outcome Measures :
  1. Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire [ Time Frame: change in self- management from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months) ]
    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

  2. Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire [ Time Frame: change in self-management from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    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

  3. Change in self-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale [ Time Frame: change in self-efficacy from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months) ]
    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

  4. Change in self-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale [ Time Frame: change in self-efficacy from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    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

  5. Change in self-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments [ Time Frame: change in sleep from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months) ]
    qualitative aspects of sleep and wake function via Likert scale of 1-5, higher scores on the scale equal better sleep

  6. Change in self-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments [ Time Frame: change in sleep from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    qualitative aspects of sleep and wake function via Likert scale of 1-5, higher scores on the scale equal better sleep

  7. Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25 [ Time Frame: change in vision quality of life from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months) ]
    vision quality of life, likert scale 1-5, higher scores on the scale equal better visual function

  8. Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25 [ Time Frame: change in vision quality of life from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    vision quality of life, likert scale 1-5, higher scores on the scale equal better visual function


Other Outcome Measures:
  1. Change in self-reported health distress, as measured by the Health Distress Questionnaire [ Time Frame: change in health distress from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months) ]
    health distress, likert scale 0-5, higher scores on the scale equal more distress.

  2. Change in self-reported health distress, as measured by the Health Distress Questionnaire [ Time Frame: change in health distress from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    health distress, likert scale 0-5, higher scores on the scale equal more distress.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Timothy Reistetter, PhD 210.450.8666 tareiste@UTMB.EDU
Contact: Kimbery P Hreha, EdD 409-747-1611 kihreha@utmb.edu

Locations
Layout table for location information
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Timothy Reistetter, PhD         
Contact: Kimberly Hreha, EdD         
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Center for Advancing Translational Science (NCATS)
The Claude D. Pepper Older Americans Independence Centers
Investigators
Layout table for investigator information
Principal Investigator: Timothy Reistetter, PhD University of Texas
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE September 3, 2019
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Feasibility: Patients Screened [ Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) ]
    number of patients screened
  • Feasibility: Eligible Patients [ Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) ]
    number of patients eligible
  • Feasibility: Patients Approached [ Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) ]
    number of patients approached
  • Feasibility: Patients Enrolled [ Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care) ]
    number of patients enrolled
  • Feasibility: Patient Refusals [ Time Frame: Collected at follow-up (2 weeks from last day of intervention) ]
    number of patient refusals
  • Feasibility: Patient Withdrawals [ Time Frame: Collected at follow-up (2 weeks from last day of intervention) ]
    number of patient withdrawals
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire [ Time Frame: change in self- management from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months) ]
    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-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire [ Time Frame: change in self-management from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    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-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale [ Time Frame: change in self-efficacy from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months) ]
    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-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale [ Time Frame: change in self-efficacy from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    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-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments [ Time Frame: change in sleep from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months) ]
    qualitative aspects of sleep and wake function via Likert scale of 1-5, higher scores on the scale equal better sleep
  • Change in self-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments [ Time Frame: change in sleep from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    qualitative aspects of sleep and wake function via Likert scale of 1-5, higher scores on the scale equal better sleep
  • Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25 [ Time Frame: change in vision quality of life from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months) ]
    vision quality of life, likert scale 1-5, higher scores on the scale equal better visual function
  • Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25 [ Time Frame: change in vision quality of life from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    vision quality of life, likert scale 1-5, higher scores on the scale equal better visual function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 18, 2019)
  • Change in self-reported health distress, as measured by the Health Distress Questionnaire [ Time Frame: change in health distress from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months) ]
    health distress, likert scale 0-5, higher scores on the scale equal more distress.
  • Change in self-reported health distress, as measured by the Health Distress Questionnaire [ Time Frame: change in health distress from base line 2 (3 months) to follow-up (2 weeks from last day of intervention) ]
    health distress, likert scale 0-5, higher scores on the scale equal more distress.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Feasibility of a Stroke Specific Self-management Program
Official Title  ICMJE Feasibility of a Stroke Specific Self-management Program
Brief Summary 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

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Stroke
  • Chronic Conditions
Intervention  ICMJE
  • Other: Self- management program

    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

  • Other: Standard care

    All stroke patients being discharged from the acute hospital receive the following care:

    1. 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.
    2. A stroke clinic appointment that is set to occur 90-days post discharge.
    3. 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.
    4. Information on local support groups.
    5. Referrals to start physical, occupational or speech therapy, if recommended by their physician.
Study Arms  ICMJE
  • Standard Care
    The standard care group will receive baseline testing #1, standard care, baseline testing #2 and follow up testing approximately 8 weeks later.
    Intervention: Other: Standard care
  • Experimental: Experimental
    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.
    Intervention: Other: Self- management program
Publications *
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  • Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015 Apr 21;10:53. doi: 10.1186/s13012-015-0242-0.
  • Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation fidelity. Implement Sci. 2007 Nov 30;2:40.
  • Living a Healthy Life with Chronic Conditions, 4th Edition. https://www.bullpub.com/living-a-healthy-life-with-chronic-conditions-4th-edition.html
  • Rees G, Keeffe JE, Hassell J, Larizza M, Lamoureux E. A self-management program for low vision: program overview and pilot evaluation. Disabil Rehabil. 2010;32(10):808-15. doi: 10.3109/09638280903304193.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019) 		90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Timothy Reistetter, PhD 210.450.8666 tareiste@UTMB.EDU
Contact: Kimbery P Hreha, EdD 409-747-1611 kihreha@utmb.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993574
Other Study ID Numbers  ICMJE 19-0006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of Texas Medical Branch, Galveston
Study Sponsor  ICMJE The University of Texas Medical Branch, Galveston
Collaborators  ICMJE
  • National Center for Advancing Translational Science (NCATS)
  • The Claude D. Pepper Older Americans Independence Centers
Investigators  ICMJE
Principal Investigator: Timothy Reistetter, PhD University of Texas
PRS Account The University of Texas Medical Branch, Galveston
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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