Virtual Reality Cognitive Intervention for Critically Ill Delirium Survivors (VR-Cog)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorIndiana University

About this trial

The purpose of this study is to measure the feasibility, acceptability of virtual reality (VR) brain games and estimate their effect on memory, attention, and mood for ICU survivors. The VR program will be used at home through a headset and hand controls.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 50 years or older

English speaking

Admitted to the intensive care unit (ICU) with acute respiratory failure/invasive mechanical ventilation

Screening positive for delirium (using Richmond Agitation Sedation Scale and Confusion Assessment Method for the ICU)

Disqualifiers

Acute neurologic injury such as stroke, traumatic brain injury, brain mass, intracranial hemorrhage, seizures, or central nervous system infection

Chronic cognitive or physical function deficit preventing participation in study interventions or assessments (determined by chart diagnoses and direct participant interview)

Chronic cognitive impairment (including mild cognitive impairment or dementia) identified by chart diagnosis, prescription of anti-dementia medications, or Informant Questionnaire on Cognitive Decline in the Elderly Score (IQCODE) >3.3 obtained from family caregiver

Severe, uncorrected vision or hearing impairment preventing participation in intervention or outcomes assessments

Trial design

Design model

Parallel

Treatments tested in this trial

  • VR-based cognitive training program

    Device

    VR-Cog features HomeTown Bound, a suite of 18 modules organized into four training categories: attention, processing speed, memory, and visuospatial.

  • VR-based attention control

    Device

    VR-AC consists of a library of 9 nature scenes (content provided by Nature Treks VR).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: VR-based cognitive training programExperimental treatment 1 intervention
Group B: VR-based attention controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Measure the feasibility of VR-Cog in older adult ICU delirium survivors

Feasibility will be measured by the percentage (%) of intervention sessions delivered to participants, with greater than or equal to 80% of intervention sessions completed defining feasibility.

Time frame
Feasibility will be measured at 4 weeks (the end of the intervention period)
2

Measure the acceptability of VR-Cog in older adult ICU delirium survivors

Acceptability will be defined as scores of 8 or greater on each subscale of the Senior Technology Acceptance Model (STAM, Short Form with 14-items). The four subscales of the STAM measure attitudes towards technology (perceived use and effectiveness), control beliefs (ability to use the technology and complete tasks), gerontologic anxiety (feeling apprehensive or hesitant with technology applications), and general health (ability to concentrate, satisfaction with general health).

Time frame
Acceptability will be measured at 4 weeks (the end of the intervention period)
3

Measure the adherence to VR-Cog in older adult ICU delirium survivors

Adherence to the protocol will be assessed through rates of retention at end of 4-week intervention (80% among participants alive and out of the hospital) and completion of outcomes assessments (80% among participants alive and out of the hospital).

Time frame
Adherence will be measured at 4 weeks (the end of the intervention period)

Secondary outcomes

1

Estimate the effect of VR-Cog on cognitive performance among older adult ICU delirium survivors.

Repeatable Battery for Assessment of Neuropsychological Status (RBANS)

Time frame
Measured at Baseline, 4 weeks (end of intervention period), 3-Month and 6-Month follow up
2

Explore the effects of VR-Cog on depression

As measured by Patient Health Questionnaire (PHQ-9)

Time frame
Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.
3

Explore the effects of VR-Cog on anxiety

As measured by Generalized Anxiety Disorder (GAD-7) scale

Time frame
Measured at baseline (hospital discharge), 4 weeks (end of intervention period), 3-months and 6-months post-randomization.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Indiana University Health

Collaborator