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Feasibility of Better Living After Stroke Through Technology (BLAST)

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BLAST
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, occupational therapy, participation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Missouri: Department of Occupational Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BLAST

Arm Description

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

Outcomes

Primary Outcome Measures

Participation Strategies Self-Efficacy Scale (change)
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)
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)
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)
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
assessment of acceptability of the intervention. Scale of 1 - 7 where 1 = lowest acceptability and 7 = most acceptability.
Post Study System Usability Questionnaire
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

Patient Health Questionnaire (PHQ-9) (change)
9-item depression scale. Total possible score = 0 - 27 where 0 = no depression and 27 = severe depression.
Executive Function Performance Test- Enhanced (EFPTe) (change)
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)
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)
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)
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.

Full Information

First Posted
April 25, 2019
Last Updated
April 9, 2021
Sponsor
University of Missouri-Columbia
Collaborators
BrightOutcome, Inc., National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03935789
Brief Title
Feasibility of Better Living After Stroke Through Technology
Acronym
BLAST
Official Title
Feasibility of Better Living After Stroke Through Technology
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
University shutdown due to COVID
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
May 18, 2020 (Actual)
Study Completion Date
May 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
Collaborators
BrightOutcome, Inc., National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, occupational therapy, participation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLAST
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
BLAST
Intervention Description
12-week self-guided intervention using a web-based platform
Primary Outcome Measure Information:
Title
Participation Strategies Self-Efficacy Scale (change)
Description
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.
Time Frame
Change from baseline score at 12 weeks (post-intervention)
Title
Activity Card Sort (change)
Description
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.
Time Frame
Change from baseline score at 12 weeks (post-intervention)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS)- 29 (change)
Description
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.
Time Frame
Change from baseline score at 12 weeks (post-intervention)
Title
Stroke Impact Scale (change)
Description
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.
Time Frame
Change from baseline score at 12 weeks (post-intervention)
Title
After Scenario Questionnaire
Description
assessment of acceptability of the intervention. Scale of 1 - 7 where 1 = lowest acceptability and 7 = most acceptability.
Time Frame
12-weeks after baseline assessment (post-intervention)
Title
Post Study System Usability Questionnaire
Description
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.
Time Frame
12-weeks after baseline assessment (post-intervention)
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9) (change)
Description
9-item depression scale. Total possible score = 0 - 27 where 0 = no depression and 27 = severe depression.
Time Frame
Change from baseline score at 12 weeks (post-intervention)
Title
Executive Function Performance Test- Enhanced (EFPTe) (change)
Description
assessment tool used to measure executive functioning in daily life activities. Scale of 0 - 5 where 0 = most independence and 5 = least independence.
Time Frame
Change from baseline score at 12 weeks (post-intervention)
Title
Functional Behavior Profile (change)
Description
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.
Time Frame
Change from baseline score at 12 weeks (post-intervention)
Title
Reintegration to Normal Living Index/Scale (change)
Description
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.
Time Frame
Change from baseline score at 12 weeks (post-intervention)
Title
Lawton Instrumental Activities of Daily Life Scale (change)
Description
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.
Time Frame
Change from baseline score at 12 weeks (post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Wolf, OTD, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri: Department of Occupational Therapy
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of Better Living After Stroke Through Technology

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