Driving Rehabilitation and Innovation for Evaluating Risk in Post-Intensive Care Unit Survivors

NCT05999903 | Active Not Recruiting

• 1 other identifier: 1R21AG080339-01
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Older adults are at risk for ICU-acquired cognitive decline discernible from clinical, biological, and imaging- related changes in the brain following delirium and critical illness. Our Driving Rehabilitation and Innovation for Evaluating Risk in Post Intensive Care Unit Survivors (DRIVE-PICS) application seeks to implement in-vehicle kinematic driving data with neurocognitive assessments for essential formative work to develop data-based insights into driving behaviors. DRIVE-PICS is designed to contribute to a critical gap in health promotion to develop an evidence-based, in-vehicle driving assessment system to provide actionable driving safety data and rehabilitation strategies tailored to older ICU survivors, the participants' care partners, and clinicians.

Conditions

Delirium; Critical Illness; Drive

Keywords

Adult; Human; Vehicle Driving; Functional Outcomes; Post-Intensive Care Syndrome (PICS); Neuro-Psychological; Cognitive; Neuro Cognitive; Intensive Care Unit (ICU); Longitudinal

Outcome Measures

Primary Outcomes (1)

• Total Driving Time

  Total driving time in minutes.

  0-6 months after hospital discharge

Secondary Outcomes (10)

• Depression

  Hospital discharge, 3 months after hospital discharge, 6 months after hospital discharge

• Executive Function

  3 months after hospital discharge, 6 months after hospital discharge

• Attention

  3 months after hospital discharge, 6 months after hospital discharge

• Working Memory

  3 months after hospital discharge, 6 months after hospital discharge

• Processing Speed

  3 months after hospital discharge, 6 months after hospital discharge

Study Arms (1)

Observational Kinematic Driving Data

Longitudinal kinematic driving data paired with neurocognitive assessments at 3- and 6-months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU survivors

You may qualify if:

• Age 40 and older.
• Must have had an ICU stay with delirium.
• Expected to survive hospital discharge.
• English proficiency
• Active driver within 4 weeks prior to index hospitalization
• Regular use of vehicle that is model year 1996 or newer

You may not qualify if:

• Communication challenges due to severe pre-existing dementia, hearing, or vision impairment.
• No access to driving.
• Loss or suspension of driver's license
• Current Incarceration

Sponsors & Collaborators

• Baylor Research Institute: lead
• National Institutes of Health (NIH): collaborator
• University of Wisconsin, Madison: collaborator
• University of Texas at Austin: collaborator
• Vanderbilt University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Baylor Scott and White Health Medical Center At Temple

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Delirium; Critical Illness; postintensive care syndrome

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Valerie Danesh, PhD

  Baylor Scott and White Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 21, 2023
• Study Start: September 13, 2023
• Primary Completion: December 9, 2024
• Study Completion: July 14, 2025
• Last Updated: February 6, 2025

Record last verified: 2024-08

Locations

US (1)