Virtually Assisted Home Rehabilitation After Acute Stroke-2 ((VAST-rehab2))

Virtually Assisted Home Rehabilitation After Acute Stroke-2 (VAST-rehab2)

The purpose of this study is to assess feasibility of a virtual rehabilitation program in stroke patients and to assess treatment effects, patient goal attainment with self-guided rehabilitation activities, barriers to and facilitators of telerehab, hospital readmission events, and social determinants of health

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Telerehabilitation (VAST 2)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed consent provided by the subject or legally authorized representative.
• Diagnosed with hemorrhagic or ischemic stroke
• Pre-stroke mRS is less than 3
• Qualifying Stroke Event must be confirmed by CT or MRI
• Recommended to participate in self-guided or in-person rehabilitation activities by a physician or rehabilitation therapist
• Must have sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
• Able to access the internet
• Mild-moderate impairments in motor or cognitive function

Exclusion Criteria:

• History of neurological or other disease resulting in significant functional impairment (e.g. Parkinson's disease, motor neuron disease, moderate dementia, arthritis, contractures or fixed anatomical abnormality).
• Subjects with a severe comorbid disorder that has reasonable likelihood of limiting survival to less than 6 months.
• Any other conditions that, in the opinion of the investigators, would preclude safe and/or effective participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Telerehabilitation (VAST 2)

Other: Telerehabilitation (VAST 2); The telehealth platform will be available by a web secure link accessible on a home computer or loaded on user friendly tablets that are customized for the patient's impairments. Telerehabilitation services will include 2 out of 3 disciplines: Occupational Therapy, Speech Therapy, Physical Therapy. All therapy interventions will be delivered by licensed therapists and will be based on patients' specific impairments and goals. Therapy intervention will be provided 3x/wk. for each of 2 disciplines. The intervention will be going on for 4 weeks which will total to 24 sessions. Self-management support with trained health coach will be integrated into 1 therapy session each week. An additional individual 30 minute session will occur with the health coach each week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The experience of the participant measured by the participant experience surveys	end of study (about 10 weeks after baseline)
Number of participants that completed all scheduled visits.	end of study (about 10 weeks after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)	This is a A 59 item questionnaire whereby subjects identify the impact of treatment on strength, hand function, mobility, activities of daily living, memory, communication, emotion, and handicap. Item responses are scored on a 5-point Likert-style scale. A score of 1 = an inability to complete the item and a score of 5 = no difficulty experienced at all. A standardized score ranging from 0 to 100 is calculated for all domains, with higher scores indicating a higher quality of life	Baseline, end of intervention (about 5 weeks after baseline)
Change in quality of life as assessed by the Short Form (SF-12)health questionnaire	This is a health related quality of life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning	Baseline, end of intervention (about 5 weeks after baseline)
Change in cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA)	Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.	Baseline, end of intervention (about 5 weeks after baseline)
Change in depression as assessed by the Patient Health Questionnaire (PHQ8)	This is an 8 item questionnaire and each is scored from 0-24 a higher number indicating more depression	Baseline, end of intervention (about 5 weeks after baseline)
Change in disability as assessed by the Modified Rankin Scale (mRS)	This scale is scored from 0(no symptoms at all) to 6 (dead), with a higher score being the worst outcome	Baseline, end of intervention (about 5 weeks after baseline)
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment	week 2
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment	week 3
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment	week 4
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment	week 5
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).	This is a 4-point scale for multiple aspects of goal attainment Total scale scores range from high of 8 to a low of 0, with higher scores indicating goal attainment	week 10
Type of technology used by stroke patients as assessed by a questionnaire	Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.	end of intervention (about 5 weeks after baseline)
Type of internet access used by stroke patients as assessed by a questionnaire	Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband	end of intervention (about 5 weeks after baseline)
Use of computer equipment by stroke patients as assessed by a questionnaire	Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones	end of intervention (about 5 weeks after baseline)
Type of issues exhibited when using the telehealth platform by stroke patients as as assessed by a questionnaire	Data will be reported categorically as number who face issues such as difficulty connecting to the telehealth platform, difficulty accessing/turning on camera, difficulty accessing/turning on audio and difficulty with calls being dropped	end of intervention (about 5 weeks after baseline)
Number of stroke patients who exhibited any issues when they use the telehealth platform		end of intervention (about 5 weeks after baseline)
Type of technology used by caregivers as assessed by a questionnaire	Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.	end of intervention (about 5 weeks after baseline)
Type of internet access used by caregivers as assessed by a questionnaire	Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband	end of intervention (about 5 weeks after baseline)
Use of computer equipment by caregivers as assessed by a questionnaire	Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones	end of intervention (about 5 weeks after baseline)
Type of issues exhibited when using the telehealth platform by caregivers as assessed by a questionnaire	Data will be reported categorically as number who face issues such as difficulty connecting to the telehealth platform, difficulty accessing/turning on camera, difficulty accessing/turning on audio and difficulty with calls being dropped	end of intervention (about 5 weeks after baseline)
Number of caregivers who exhibited any issues when they use the telehealth platform		end of intervention (about 5 weeks after baseline)
Incidence of events that may lead to hospital readmission and falls as assessed by the adverse events		end of intervention (about 5 weeks after baseline)
Number of patients living in underserved areas		Baseline
Number of patients living in under resourced neighborhoods		Baseline
Socio Economic Status (SES) of patients as assessed by the patient demographics		Baseline
Housing condition of patients as assessed by the patient demographics		Baseline
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 2
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 3
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 4
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 5
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 2
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 3
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 4
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.		week 5

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Lone Star Stroke Consortium
• Investigators: Principal Investigator: Sean Savitz, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: telerehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HSC-MS-22-1005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No