Clinical trial NCT03935789: Feasibility of Better Living After Stroke Through Technology
Official title: Feasibility of Better Living After Stroke Through Technology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: stroke
occupational therapy
participation
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: BrightOutcome
name: National Institute of Nursing Research (NINR)
First posted: 2019-05-02
Enrollment: 7
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group feasibility study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Participation Strategies Self-Efficacy Scale (change)
timeFrame: Change from baseline score at 12 weeks (post-intervention)
measure: Activity Card Sort (change)
timeFrame: Change from baseline score at 12 weeks (post-intervention)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)- 29 (change)
timeFrame: Change from baseline score at 12 weeks (post-intervention)
measure: Stroke Impact Scale (change)
timeFrame: Change from baseline score at 12 weeks (post-intervention)
measure: After Scenario Questionnaire
timeFrame: 12-weeks after baseline assessment (post-intervention)
measure: Post Study System Usability Questionnaire
timeFrame: 12-weeks after baseline assessment (post-intervention)
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9) (change)
timeFrame: Change from baseline score at 12 weeks (post-intervention)
measure: Executive Function Performance Test- Enhanced (EFPTe) (change)
timeFrame: Change from baseline score at 12 weeks (post-intervention)
measure: Functional Behavior Profile (change)
timeFrame: Change from baseline score at 12 weeks (post-intervention)
measure: Reintegration to Normal Living Index/Scale (change)
timeFrame: Change from baseline score at 12 weeks (post-intervention)
measure: Lawton Instrumental Activities of Daily Life Scale (change)
timeFrame: Change from baseline score at 12 weeks (post-intervention)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri: Department of Occupational Therapy
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Timothy Wolf, OTD, PhD
role: PRINCIPAL_INVESTIGATOR
References: