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NCT Number: NCT06580548

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHW-supported telerehabilitation

Device

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

Usual Care

Other

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  1. Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire

    Time frame: Baseline

    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

  2. Acceptability/Appropriateness of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire

    Time frame: 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

  3. Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire

    Time frame: Baseline

    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

  4. Adoption of the intervention for the stroke survivors as assessed by the Quantitative Implementation Measures for Stroke Survivors questionnaire

    Time frame: 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

  5. Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire

    Time frame: Baseline

    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

  6. Acceptability & Appropriateness of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire

    Time frame: 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

  7. Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire

    Time frame: Baseline

    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

  8. Adoption of the intervention for the community health workers as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire

    Time frame: 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

  9. Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire

    Time frame: Baseline

    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

  10. Feasibility of Community Health Worker as assessed by the Quantitative Implementation Measures for Community Health Worker questionnaire

    Time frame: 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

  11. Feasibility as assessed by the number of participants enrolled

    Time frame: end of study (week 7)

  12. Adherence as assessed by the number of rehab videos watched in a day

    Time frame: end of study (week 7)

    adherence is defined by ≥1 daily mobile rehab video usage

  13. Number of participants that view ≥1 daily mobile rehab videos

    Time frame: end of study (week 7)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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