Feasibility of Better Living After Stroke Through Technology

NCT ID: NCT03935789

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-25
• Study Completion Date: 2020-05-18

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

BLAST

Intervention Type: BEHAVIORAL

12-week self-guided intervention using a web-based platform

Interventions

BLAST

12-week self-guided intervention using a web-based platform

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrightOutcome

INDUSTRY

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Timothy J Wolf

Associate Professor, Occupational Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy Wolf, OTD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri: Department of Occupational Therapy

Columbia, Missouri, United States

Countries

United States

Other Identifiers

R44NR016183

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013982

Identifier Type: -

Identifier Source: org_study_id