A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande Valley
- Conditions
- Stroke
- Registration Number
- NCT06580548
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire week 7 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 week 7 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 week 7 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 week 7 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 week 7 (immediately after intervention) 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)
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States