Back to resultsVirtually Assisted Home Rehabilitation After Acute Stroke-2 ((VAST-rehab2))
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telerehabilitation (VAST 2)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring telerehabilitation
Eligibility Criteria
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.
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telerehabilitation (VAST 2)
Arm Description
Outcomes
Primary Outcome Measures
The experience of the participant measured by the participant experience surveys
Number of participants that completed all scheduled visits.
Secondary Outcome Measures
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
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
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.
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
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
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
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
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
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
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
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.
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
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
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
Number of stroke patients who exhibited any issues when they use the telehealth platform
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.
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
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
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
Number of caregivers who exhibited any issues when they use the telehealth platform
Incidence of events that may lead to hospital readmission and falls as assessed by the adverse events
Number of patients living in underserved areas
Number of patients living in under resourced neighborhoods
Socio Economic Status (SES) of patients as assessed by the patient demographics
Housing condition of patients as assessed by the patient demographics
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Full Information
NCT ID
NCT05737524
First Posted
January 27, 2023
Last Updated
March 29, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Lone Star Stroke Consortium
1. Study Identification
Unique Protocol Identification Number
NCT05737524
Brief Title
Virtually Assisted Home Rehabilitation After Acute Stroke-2
Acronym
(VAST-rehab2)
Official Title
Virtually Assisted Home Rehabilitation After Acute Stroke-2 (VAST-rehab2)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
January 23, 2024 (Anticipated)
Study Completion Date
April 23, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Lone Star Stroke Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation (VAST 2)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Telerehabilitation (VAST 2)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The experience of the participant measured by the participant experience surveys
Time Frame
end of study (about 10 weeks after baseline)
Title
Number of participants that completed all scheduled visits.
Time Frame
end of study (about 10 weeks after baseline)
Secondary Outcome Measure Information:
Title
Change in impact of stroke as assessed by the Stroke Impact Scale (SIS)
Description
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
Time Frame
Baseline, end of intervention (about 5 weeks after baseline)
Title
Change in quality of life as assessed by the Short Form (SF-12)health questionnaire
Description
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
Time Frame
Baseline, end of intervention (about 5 weeks after baseline)
Title
Change in cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA)
Description
Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.
Time Frame
Baseline, end of intervention (about 5 weeks after baseline)
Title
Change in depression as assessed by the Patient Health Questionnaire (PHQ8)
Description
This is an 8 item questionnaire and each is scored from 0-24 a higher number indicating more depression
Time Frame
Baseline, end of intervention (about 5 weeks after baseline)
Title
Change in disability as assessed by the Modified Rankin Scale (mRS)
Description
This scale is scored from 0(no symptoms at all) to 6 (dead), with a higher score being the worst outcome
Time Frame
Baseline, end of intervention (about 5 weeks after baseline)
Title
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
Description
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
Time Frame
week 2
Title
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
Description
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
Time Frame
week 3
Title
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
Description
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
Time Frame
week 4
Title
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
Description
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
Time Frame
week 5
Title
Patient goal attainment with self-guided rehabilitation activities as assessed by the Goal Attainment Measure for Stroke (GAMS).
Description
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
Time Frame
week 10
Title
Type of technology used by stroke patients as assessed by a questionnaire
Description
Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Type of internet access used by stroke patients as assessed by a questionnaire
Description
Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Use of computer equipment by stroke patients as assessed by a questionnaire
Description
Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Type of issues exhibited when using the telehealth platform by stroke patients as as assessed by a questionnaire
Description
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
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Number of stroke patients who exhibited any issues when they use the telehealth platform
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Type of technology used by caregivers as assessed by a questionnaire
Description
Data will be reported categorically as number who use each type of technology, including cell phone, smart phone, tablet, laptop, and desktop.
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Type of internet access used by caregivers as assessed by a questionnaire
Description
Data will be reported categorically as number who use each type of internet access including private wifi,public wifi, mobile data, hotspot, broadband
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Use of computer equipment by caregivers as assessed by a questionnaire
Description
Data will be reported categorically as number who use each type of computer equipment , including a mouse and headphones
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Type of issues exhibited when using the telehealth platform by caregivers as assessed by a questionnaire
Description
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
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Number of caregivers who exhibited any issues when they use the telehealth platform
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Incidence of events that may lead to hospital readmission and falls as assessed by the adverse events
Time Frame
end of intervention (about 5 weeks after baseline)
Title
Number of patients living in underserved areas
Time Frame
Baseline
Title
Number of patients living in under resourced neighborhoods
Time Frame
Baseline
Title
Socio Economic Status (SES) of patients as assessed by the patient demographics
Time Frame
Baseline
Title
Housing condition of patients as assessed by the patient demographics
Time Frame
Baseline
Title
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame
week 2
Title
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame
week 3
Title
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame
week 4
Title
Diastolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame
week 5
Title
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame
week 2
Title
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame
week 3
Title
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame
week 4
Title
Systolic blood pressure assessed during virtual sessions using a web-based rehabilitation platform.
Time Frame
week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Savitz, MD
Phone
(713) 500-7083
Email
Sean.I.Savitz@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Stevens, OTR
Phone
713-500-7914
Email
emily.a.stevens@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Savitz, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Savitz, MD
Phone
713-500-7083
Email
Sean.I.Savitz@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Emily Stevens, OTR
Phone
713-500-7914
Email
emily.a.stevens@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtually Assisted Home Rehabilitation After Acute Stroke-2
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