Clinical trial NCT06580548: A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande Valley
Official title: A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande Valley
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: long-term rehabilitation management
stroke survivor
telehealth
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (routine)
timeFrame: Baseline (week 1), week 3 (intervention participants only), week 6
measure: Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (low function )
timeFrame: Baseline (week 1), week 3 (intervention participants only), week 6
measure: Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (routine)
timeFrame: Baseline (week 1), week 3 (intervention participants only), week 6
measure: Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (low function)
timeFrame: Baseline (week 1), week 3 (intervention participants only), week 6
measure: 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)
timeFrame: Baseline, week 3 (intervention participants only), week 6
measure: Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline, week 3 (intervention participants only), week 6
measure: Change in caregiver burden as assessed by the Zarit Burden Interview
timeFrame: Baseline, week 3 (intervention participants only), week 6
Secondary outcomes:
measure: Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
timeFrame: Baseline
measure: Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
timeFrame: week 7
measure: Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
timeFrame: Baseline
measure: Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire
timeFrame: week 7
measure: Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
timeFrame: Baseline
measure: Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
timeFrame: week 7
measure: Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
timeFrame: Baseline
measure: Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
timeFrame: week 7
measure: Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
timeFrame: Baseline
measure: Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire
timeFrame: week 7 (immediately after intervention)
measure: Feasibility as assessed by the number of participants enrolled
timeFrame: end of study (week 7)
measure: Adherence as assessed by the number of rehab videos watched in a day
timeFrame: end of study (week 7)
measure: Number of participants that view ≥1 daily mobile rehab videos
timeFrame: end of study (week 7)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Fadi Musfee, MD
role: PRINCIPAL_INVESTIGATOR
References: