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

NCT06580548 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: HSC-SPH-24-01661UM1TR004906
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

long-term rehabilitation management; stroke survivor; telehealth

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (13)

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

  Baseline

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

  week 7

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

  Baseline

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

  week 7

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

  Baseline

Study Arms (1)

CHW-supported telerehabilitation plus Usual Care

EXPERIMENTAL

Device: CHW-supported telerehabilitation; Other: Usual Care

Interventions

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

CHW-supported telerehabilitation plus Usual Care

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.

CHW-supported telerehabilitation plus Usual Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Fadi Musfee, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: March 17, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)