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A New At-home Telerehabilitation Care Service Delivery Model for Stroke Survivors in the Rio Grande Valley

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Begins enrollment this month

Conditions

Stroke

Treatments

Other: Usual Care
Device: CHW-supported telerehabilitation

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06580548
1UM1TR004906 (U.S. NIH Grant/Contract)
HSC-SPH-24-0166

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

CHW-supported telerehabilitation
Experimental group
Treatment:
Device: CHW-supported telerehabilitation
Usual care
Active Comparator group
Treatment:
Other: Usual Care

Trial contacts and locations

1

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Central trial contact

Fadi Musfee, MD; Ruth S Yanes Bengoa

Data sourced from clinicaltrials.gov

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