A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande Valley
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (routine)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
CHW-supported telerehabilitation plus Usual Care
Intervention: CHW-supported telerehabilitation (Device)
CHW-supported telerehabilitation plus Usual Care
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (routine)
Time Frame: 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 )
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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 Outcomes
- Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire(Baseline)
- Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire(Baseline)
- Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire(Baseline)
- Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire(Baseline)
- Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire(Baseline)
- Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire(week 7)
- Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire(week 7)
- Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire(week 7)
- Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire(week 7)
- Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire(week 7 (immediately after intervention))
- 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))
- Number of participants that view ≥1 daily mobile rehab videos(end of study (week 7))
Investigators
Fadi Musfee
Assistant Professor
The University of Texas Health Science Center, Houston