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

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 Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: CHW-supported telerehabilitation; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CHW-supported telerehabilitation plus Usual Care

Device: CHW-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; Other: Usual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (routine)	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	Baseline (week 1), week 3 (intervention participants only), week 6
Change in basic mobility as assessed by the Acute Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Form (low function )	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	Baseline (week 1), week 3 (intervention participants only), week 6
Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (routine)	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	Baseline (week 1), week 3 (intervention participants only), week 6
Change in basic activity as Acute Measure for Post-Acute Care (AM-PAC) Daily Activity Outpatient Short Form (low function)	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	Baseline (week 1), week 3 (intervention participants only), week 6
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)	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	Baseline, week 3 (intervention participants only), week 6
Change in Depression as assessed by the Patient Health Questionnaire 9 (PHQ-9)	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	Baseline, week 3 (intervention participants only), week 6
Change in caregiver burden as assessed by the Zarit Burden Interview	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	Baseline, week 3 (intervention participants only), week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire	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	Baseline
Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire	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	week 7
Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire	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	Baseline
Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire	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	week 7
Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire	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	Baseline
Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire	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	week 7
Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire	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	Baseline
Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire	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	week 7
Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire	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	Baseline
Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire	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	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	adherence is defined by ≥1 daily mobile rehab video usage	end of study (week 7)
Number of participants that view ≥1 daily mobile rehab videos		end of study (week 7)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Fadi Musfee, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: telehealth; stroke survivor; long-term rehabilitation management
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: HSC-SPH-24-0166; 1UM1TR004906 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No