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出境医 / 临床实验 / Feasibility of Better Living After Stroke Through Technology (BLAST)

Feasibility of Better Living After Stroke Through Technology (BLAST)

Study Description
Brief Summary:
The investigators propose to evaluate the feasibility of Better Living After Stroke through Technology (BLAST) to help stroke survivors and family members return back to their productive and meaningful lives by proactively 1) helping them set their activity goals using ACS, 2) assessing their behavioral/functional capabilities using FBP, 3) recognizing symptoms indicative potential secondary stroke risks, 4) engaging support from online/community resources, and 5) offering tailored self-management recommendations using evidence-based strategies on how to achieve their activity goals and avoid secondary stroke based on their capabilities, stroke-related symptoms and available social resources.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: BLAST Not Applicable

Detailed Description:

Stroke, which is the leading cause of disability, cognitive impairment and death in the US, imposes significant financial and personal burden. Although the residual effects of stroke affect many aspects of life, many aspects are not addressed by traditional rehabilitation treatments. In particular, persons with mild stroke, typically defined as a stroke with no or slight motor impairment and a high level of independence in basic activities of daily living, often experience emotional problems, subtle but significant cognitive impairment and decreased participation in productive, social and leisure activity. Despite these problems, persons with mild stroke are typically discharged to home without further referral to health or rehabilitation services other than follow-up with primary care physicians.

This application is in response to RFA PA-11-335 (Lab to Marketplace: Tools for Biomedical and Behavioral Research), a special 2-year Phase I SBIR program to accelerate the translation of behavioral research from academic to the marketplace. The project is based on the extensive research that developed and tested reliable and valid measures of activity participation (Activity Card Sort, or ACS) and cognitive skills supporting performance of simple and complex functional tasks (Functional Behavior Profile, or FBP). These measures have been used to guide treatments to help persons with mild cognitive impairment and their families support functional independence. These measures and the results of other studies will be used to build a dynamic online self-management tool designed to help persons with mild stroke develop individualized strategies that will support optimal recovery.

The investigators propose to evaluate the feasibility of Better Living After Stroke through Technology (BLAST) to help stroke survivors and family members return back to their productive and meaningful lives by proactively 1) helping them set their activity goals using ACS, 2) assessing their behavioral/functional capabilities using FBP, 3) recognizing symptoms indicative potential secondary stroke risks, 4) engaging support from online/community resources, and 5) offering tailored self-management recommendations using evidence-based strategies on how to achieve their activity goals and avoid secondary stroke based on their capabilities, stroke-related symptoms and available social resources.

Stroke survivors and family using the BLAST system are expected to have 1) better life satisfaction as measured by the Overall Recovery item of the Stroke Impact Scale; 2) increased activity as measured by Activity Card Sort; 3) better problem-solving and task performance as measured by Functional Behavior Profile; and 4) fewer caregiver concerns as measured by the Stroke Caregiver Needs Scale.

Specific Aims: 1) to evaluate the acceptability of BLAST ; and 2) to evaluate the preliminary effect of BLAST on self-efficacy, participation, and community reintegration.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Better Living After Stroke Through Technology
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : May 18, 2020
Actual Study Completion Date : May 18, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: BLAST
All participants in this study will be assigned to this group to participate in the BLAST intervention. The intervention will be a self-guided web-based platform using a self-management model to help support better engagement in everyday life activity
Behavioral: BLAST
12-week self-guided intervention using a web-based platform

Outcome Measures
Primary Outcome Measures :
  1. Participation Strategies Self-Efficacy Scale (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    35-item scale designed to assess self-efficacy in using participation strategies following a stroke using six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work/productivity, (5) managing communication, and (6) advocating for resources, where higher scores equate to more self-efficacy.

  2. Activity Card Sort (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    records the activity participation and engagement of adults in instrumental, leisure and social activities currently and prior to a health event. Possible scores 0 - 32 where 32 indicates the most activity.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS)- 29 (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    generic health-related quality of life survey, assesses each of the 7 PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. Scale of 1 - 5, where 1 = poorest quality of life and 5 = best quality of life.

  4. Stroke Impact Scale (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function Activities of Daily Living / Instrumental Activities of Daily Living, mobility, communication, emotion, memory and thinking, and participation. Total possible score = 59 - 295 where 295 = the least impact of stroke.

  5. After Scenario Questionnaire [ Time Frame: 12-weeks after baseline assessment (post-intervention) ]
    assessment of acceptability of the intervention. Scale of 1 - 7 where 1 = lowest acceptability and 7 = most acceptability.

  6. Post Study System Usability Questionnaire [ Time Frame: 12-weeks after baseline assessment (post-intervention) ]
    assessment of participant satisfaction and evaluation of usability of the web-based platform. Scale of 1 - 7 where 1 = least satisfaction and 7 = most satisfaction.


Secondary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    9-item depression scale. Total possible score = 0 - 27 where 0 = no depression and 27 = severe depression.

  2. Executive Function Performance Test- Enhanced (EFPTe) (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    assessment tool used to measure executive functioning in daily life activities. Scale of 0 - 5 where 0 = most independence and 5 = least independence.

  3. Functional Behavior Profile (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    clinical assessment measure that provides caregivers with a method of describing the impaired person's capabilities in performing tasks, social interactions, and problem-solving following a stroke. Total possible score = 0 - 108 where 108 = most functional behavior.

  4. Reintegration to Normal Living Index/Scale (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    assessment of the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities (e.g. recreation, movement in the community, and interaction in family or other relationships). Total possible score = 0 - 100 where 100 = total reintegration.

  5. Lawton Instrumental Activities of Daily Life Scale (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    assessment for identifying how a person is functioning at the present time and for identifying improvement or deterioration over time in IADL activities. Total possible score = 0 - 8 where 8 = high function.


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 55 years of age and older
  • diagnosis of mild to moderate ischemic stroke (NIHSS <16)
  • 3 months to 5 years post-stroke onset (of most recent stroke)
  • the availability of a willing caregiver or supportive individual throughout the intervention
  • access to a computer or tablet with internet access
  • discharged from the hospital to the community
  • able to read, write, and speak English fluently; and (8) community dwelling

Exclusion Criteria:

  • history of functional impairment prior to the index stroke as self-reported on the Telephone Screening Form
  • current diagnosis of a severe psychiatric disorder
  • current drug/alcohol abuse
  • terminal illness
  • Montreal Cognitive Assessment score of less than 23
  • direct verbal cue required for EFPTe test
  • severe depressive symptoms as indicated on the Patient Health Questionnaire (PHQ-9 score greater than 19)
  • any thoughts of harming themselves or others as indicated on question #9 of the PHQ-9.
Contacts and Locations

Locations
Layout table for location information
United States, Missouri
University of Missouri: Department of Occupational Therapy
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
BrightOutcome, Inc.
National Institute of Nursing Research (NINR)
Investigators
Layout table for investigator information
Principal Investigator: Timothy Wolf, OTD, PhD University of Missouri-Columbia
Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE April 25, 2019
Actual Primary Completion Date May 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Participation Strategies Self-Efficacy Scale (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    35-item scale designed to assess self-efficacy in using participation strategies following a stroke using six subscales: (1) managing home participation, (2) staying organized, (3) planning and managing community participation, (4) managing work/productivity, (5) managing communication, and (6) advocating for resources, where higher scores equate to more self-efficacy.
  • Activity Card Sort (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    records the activity participation and engagement of adults in instrumental, leisure and social activities currently and prior to a health event. Possible scores 0 - 32 where 32 indicates the most activity.
  • Patient-Reported Outcomes Measurement Information System (PROMIS)- 29 (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    generic health-related quality of life survey, assesses each of the 7 PROMIS domains: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities. Scale of 1 - 5, where 1 = poorest quality of life and 5 = best quality of life.
  • Stroke Impact Scale (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function Activities of Daily Living / Instrumental Activities of Daily Living, mobility, communication, emotion, memory and thinking, and participation. Total possible score = 59 - 295 where 295 = the least impact of stroke.
  • After Scenario Questionnaire [ Time Frame: 12-weeks after baseline assessment (post-intervention) ]
    assessment of acceptability of the intervention. Scale of 1 - 7 where 1 = lowest acceptability and 7 = most acceptability.
  • Post Study System Usability Questionnaire [ Time Frame: 12-weeks after baseline assessment (post-intervention) ]
    assessment of participant satisfaction and evaluation of usability of the web-based platform. Scale of 1 - 7 where 1 = least satisfaction and 7 = most satisfaction.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Patient Health Questionnaire (PHQ-9) (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    9-item depression scale. Total possible score = 0 - 27 where 0 = no depression and 27 = severe depression.
  • Executive Function Performance Test- Enhanced (EFPTe) (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    assessment tool used to measure executive functioning in daily life activities. Scale of 0 - 5 where 0 = most independence and 5 = least independence.
  • Functional Behavior Profile (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    clinical assessment measure that provides caregivers with a method of describing the impaired person's capabilities in performing tasks, social interactions, and problem-solving following a stroke. Total possible score = 0 - 108 where 108 = most functional behavior.
  • Reintegration to Normal Living Index/Scale (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    assessment of the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities (e.g. recreation, movement in the community, and interaction in family or other relationships). Total possible score = 0 - 100 where 100 = total reintegration.
  • Lawton Instrumental Activities of Daily Life Scale (change) [ Time Frame: Change from baseline score at 12 weeks (post-intervention) ]
    assessment for identifying how a person is functioning at the present time and for identifying improvement or deterioration over time in IADL activities. Total possible score = 0 - 8 where 8 = high function.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of Better Living After Stroke Through Technology
Official Title  ICMJE Feasibility of Better Living After Stroke Through Technology
Brief Summary The investigators propose to evaluate the feasibility of Better Living After Stroke through Technology (BLAST) to help stroke survivors and family members return back to their productive and meaningful lives by proactively 1) helping them set their activity goals using ACS, 2) assessing their behavioral/functional capabilities using FBP, 3) recognizing symptoms indicative potential secondary stroke risks, 4) engaging support from online/community resources, and 5) offering tailored self-management recommendations using evidence-based strategies on how to achieve their activity goals and avoid secondary stroke based on their capabilities, stroke-related symptoms and available social resources.
Detailed Description

Stroke, which is the leading cause of disability, cognitive impairment and death in the US, imposes significant financial and personal burden. Although the residual effects of stroke affect many aspects of life, many aspects are not addressed by traditional rehabilitation treatments. In particular, persons with mild stroke, typically defined as a stroke with no or slight motor impairment and a high level of independence in basic activities of daily living, often experience emotional problems, subtle but significant cognitive impairment and decreased participation in productive, social and leisure activity. Despite these problems, persons with mild stroke are typically discharged to home without further referral to health or rehabilitation services other than follow-up with primary care physicians.

This application is in response to RFA PA-11-335 (Lab to Marketplace: Tools for Biomedical and Behavioral Research), a special 2-year Phase I SBIR program to accelerate the translation of behavioral research from academic to the marketplace. The project is based on the extensive research that developed and tested reliable and valid measures of activity participation (Activity Card Sort, or ACS) and cognitive skills supporting performance of simple and complex functional tasks (Functional Behavior Profile, or FBP). These measures have been used to guide treatments to help persons with mild cognitive impairment and their families support functional independence. These measures and the results of other studies will be used to build a dynamic online self-management tool designed to help persons with mild stroke develop individualized strategies that will support optimal recovery.

The investigators propose to evaluate the feasibility of Better Living After Stroke through Technology (BLAST) to help stroke survivors and family members return back to their productive and meaningful lives by proactively 1) helping them set their activity goals using ACS, 2) assessing their behavioral/functional capabilities using FBP, 3) recognizing symptoms indicative potential secondary stroke risks, 4) engaging support from online/community resources, and 5) offering tailored self-management recommendations using evidence-based strategies on how to achieve their activity goals and avoid secondary stroke based on their capabilities, stroke-related symptoms and available social resources.

Stroke survivors and family using the BLAST system are expected to have 1) better life satisfaction as measured by the Overall Recovery item of the Stroke Impact Scale; 2) increased activity as measured by Activity Card Sort; 3) better problem-solving and task performance as measured by Functional Behavior Profile; and 4) fewer caregiver concerns as measured by the Stroke Caregiver Needs Scale.

Specific Aims: 1) to evaluate the acceptability of BLAST ; and 2) to evaluate the preliminary effect of BLAST on self-efficacy, participation, and community reintegration.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single group feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE Behavioral: BLAST
12-week self-guided intervention using a web-based platform
Study Arms  ICMJE Experimental: BLAST
All participants in this study will be assigned to this group to participate in the BLAST intervention. The intervention will be a self-guided web-based platform using a self-management model to help support better engagement in everyday life activity
Intervention: Behavioral: BLAST
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 9, 2021)
7
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2019)
40
Actual Study Completion Date  ICMJE May 18, 2020
Actual Primary Completion Date May 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 55 years of age and older
  • diagnosis of mild to moderate ischemic stroke (NIHSS <16)
  • 3 months to 5 years post-stroke onset (of most recent stroke)
  • the availability of a willing caregiver or supportive individual throughout the intervention
  • access to a computer or tablet with internet access
  • discharged from the hospital to the community
  • able to read, write, and speak English fluently; and (8) community dwelling

Exclusion Criteria:

  • history of functional impairment prior to the index stroke as self-reported on the Telephone Screening Form
  • current diagnosis of a severe psychiatric disorder
  • current drug/alcohol abuse
  • terminal illness
  • Montreal Cognitive Assessment score of less than 23
  • direct verbal cue required for EFPTe test
  • severe depressive symptoms as indicated on the Patient Health Questionnaire (PHQ-9 score greater than 19)
  • any thoughts of harming themselves or others as indicated on question #9 of the PHQ-9.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935789
Other Study ID Numbers  ICMJE 2013982
R44NR016183 ( U.S. NIH Grant/Contract )
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 Timothy J Wolf, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE
  • BrightOutcome, Inc.
  • National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Timothy Wolf, OTD, PhD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date April 2021

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