Feasibility of Better Living After Stroke Through Technology

Stroke Clinical Trial

— BLAST  

Official title:

Feasibility of Better Living After Stroke Through Technology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03935789
• Other study ID #: 2013982
• Secondary ID: R44NR016183
• Status: Terminated
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: May 18, 2020

Study information

• Verified date: April 2021
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• BLAST
12-week self-guided intervention using a web-based platform

Locations

Country	Name	City	State
United States	University of Missouri: Department of Occupational Therapy	Columbia	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
University of Missouri-Columbia	BrightOutcome, Inc., National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline score at 12 weeks (post-intervention)
Primary	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.	Change from baseline score at 12 weeks (post-intervention)
Primary	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.	Change from baseline score at 12 weeks (post-intervention)
Primary	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.	Change from baseline score at 12 weeks (post-intervention)
Primary	After Scenario Questionnaire	assessment of acceptability of the intervention. Scale of 1 - 7 where 1 = lowest acceptability and 7 = most acceptability.	12-weeks after baseline assessment (post-intervention)
Primary	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.	12-weeks after baseline assessment (post-intervention)
Secondary	Patient Health Questionnaire (PHQ-9) (change)	9-item depression scale. Total possible score = 0 - 27 where 0 = no depression and 27 = severe depression.	Change from baseline score at 12 weeks (post-intervention)
Secondary	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.	Change from baseline score at 12 weeks (post-intervention)
Secondary	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.	Change from baseline score at 12 weeks (post-intervention)
Secondary	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.	Change from baseline score at 12 weeks (post-intervention)
Secondary	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.	Change from baseline score at 12 weeks (post-intervention)