Stroke
Conditions
Keywords
long-term rehabilitation management, stroke survivor, telehealth
Brief summary
The purpose of this study is to investigate the feasibility of a mobile telerehabilitation software for post-acute stroke care for Rio Grande Valley (RGV) stroke survivors with community health worker (CHW) at-home support and to estimate the functional health, mental health (depression), and caregiver burden outcomes of this new CHW-supported, at-home rehabilitation service delivery model and to identify salient barriers to and facilitators of adopting and delivering the new rehabilitation delivery model to further disseminate the model in real-world communities.
Interventions
DEVICECHW-supported telerehabilitation
Participants will receive the Mobile Rehab mobile software, which allows participants to be prescribed personalized rehabilitation strengthening video regimens electronically based on respondent-indicated mobility and activities of daily living functionality
OTHERUsual Care
Participants will be provide a list of local social services resources, including mental health, that participants can use . A callback number will be provided if they have any questions about the services.
Sponsors
The University of Texas Health Science Center, Houston
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A resident of the Brownsville, Texas (Cameron County) area * SINGLE and FIRST qualifying stroke event with the ability to enroll and begin study activities within 3 months of onset of stroke event * Pre-stroke modified Rankin score of ≤3 (less than moderate disability at baseline) * Currently uninsured * Spanish or English speaker * Able to follow instructions (without aphasia that interferes with following instructions) * Safe to perform basic strengthening rehabilitation exercises * Able to stand with or without assistance
Exclusion criteria
* Aphasia or cognitive impairment (e.g., dementia) that interferes with following instructions or prevents following the study-related activities) * Pre-stroke motor deficits * Current psychiatric disorders, including substance use disorder * Underlying brain pathologies inclusive of brain malignancies, multiple sclerosis * Insured patients as insured patients are referred for standard-of-care clinical rehabilitation. * Medical instability to participate in basic strengthening rehabilitation exercises * Inability to access internet from home to access at-home rehabilitation software for intervention arm participants * Having received any outpatient rehabilitation services prior to study enrollment for intervention arm participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (routine) | Baseline (week 1), week 3 (intervention participants only), week 6 | This is an 18 item questionnaire and each is scored from 1(unable) to 4( none) for a score range of 1-72, higher score indicating better outcome |
| Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (low function ) | Baseline (week 1), week 3 (intervention participants only), week 6 | This is a 19 item questionnaire and each is scored from 0(unable) to 3( none) for a score range of 0-57, higher score indicating better outcome |
| Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (routine) | Baseline (week 1), week 3 (intervention participants only), week 6 | This is a 15 item questionnaire and each is scored from 1(unable) to 4( none) for a score range of 1-60, higher score indicating better outcome |
| Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (low function) | Baseline (week 1), week 3 (intervention participants only), week 6 | This is a 12 item questionnaire and each is scored from 0(total) to 3( none) for a score range of 1-36, higher score indicating better outcome |
| Change in Health-related quality of life as assessed by the European Health-Related Quality of Life- 5 Dimensions (EQ-5D) EuroQoL-5D five-level survey (EQ-5D-5L) | Baseline, week 3 (intervention participants only), week 6 | This is scored across 5 dimensions , mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and each dimension is scored on a five-level severity ranking that ranges from 1 (no problems) to 5 (extreme problems), higher score indicating worse outcome |
| Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ-9) | Baseline, week 3 (intervention participants only), week 6 | This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a score range of 0-27, higher score indicating worse outcome |
| Change in caregiver burden as assessed by the Zarit Burden Interview | Baseline, week 3 (intervention participants only), week 6 | This is a 12 item questionnaire and each is scored from 0(never) to 4(nearly always) for a score range of 0-48, higher score indicating worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire | Baseline | This is an 8 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-40, higher score indicating better outcome |
| Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire | Baseline | This is an 5 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-25, higher score indicating better outcome |
| Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire | Baseline | This is an 7 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-35, higher score indicating better outcome |
| Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire | Baseline | This is an 4 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-20, higher score indicating better outcome |
| Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire | Baseline | This is an 7 item questionnaire and each is scored from 1( strongly disagree) to 5(strongly agree) for a score range of 1-35, higher score indicating better outcome |
| Feasibility as assessed by the number of participants enrolled | end of study (week 7) | — |
| Adherence as assessed by the number of rehab videos watched in a day | end of study (week 7) | adherence is defined by ≥1 daily mobile rehab video usage |
| Number of participants that view ≥1 daily mobile rehab videos | end of study (week 7) | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFadi Musfee, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed