Feasibility of Better Living After Stroke Through Technology

NCT03935789 | Terminated

• 2 other identifiers: 2013982R44NR016183
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; occupational therapy; participation

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (5)

• Patient Health Questionnaire (PHQ-9) (change)

  Change from baseline score at 12 weeks (post-intervention)

• Executive Function Performance Test- Enhanced (EFPTe) (change)

  Change from baseline score at 12 weeks (post-intervention)

• Functional Behavior Profile (change)

  Change from baseline score at 12 weeks (post-intervention)

• Reintegration to Normal Living Index/Scale (change)

  Change from baseline score at 12 weeks (post-intervention)

• Lawton Instrumental Activities of Daily Life Scale (change)

  Change from baseline score at 12 weeks (post-intervention)

Study Arms (1)

BLAST

EXPERIMENTAL

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

Interventions

BLAST BEHAVIORAL

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

BLAST

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• diagnosis of mild to moderate ischemic stroke (NIHSS \<16)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• BrightOutcome: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Missouri: Department of Occupational Therapy

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Timothy Wolf, OTD, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Occupational Therapy

Model Details: Single group feasibility study

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 2, 2019
• Study Start: April 25, 2019
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)