Improving Everyday Task Performance Through Repeated Practice in Virtual Reality.

NCT04315337 | Completed

• 1 other identifier: AG066771
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

There are very few effective interventions that promote functional independence in people with Alzheimer's disease (AD) and related dementias. This R21 project is the first step in the long-term goal of developing an effective, enjoyable, portable, and inexpensive non-immersive virtual reality (VR) training intervention for improving the performance of everyday tasks. The investigators' VR training approach is built upon the results of past studies that show 1) when people with AD repeatedly practice daily tasks they subsequently perform them more completely and without error; and 2) healthy people are able to transfer skills learned in VR-contexts to tasks in the real world. This R21 study will obtain preliminary data to inform a future randomized clinical trial through three aims: Aim 1) To test the hypothesis that individuals with mild-moderate AD will show improved performance on an everyday task after repeatedly practicing the task in a non-immersive VR setting; Aim 2) To explore usability and acceptability of the VR training as well as associations between individual differences variables (e.g., cognitive abilities, demographics) and training effects. To test Aim 1, 40 participants with mild to moderate AD will be recruited to complete daily VR Training sessions for one week. VR Training will include repeated practice of a single, everyday task in a non-immersive VR-context (VR Breakfast or VR Lunch; counterbalanced across participants). The primary outcome measure is performance of the real-life version of the trained task, which will be collected before and at two time points after training, compared to performance of an untrained, control task of comparable difficulty, and scored from video by coders blinded to training task/condition. To evaluate Aim 2, all participants and an informant will complete interviews and questionnaires and participants will complete tests of cognitive abilities. Usability and acceptability of the VR training will be evaluated and associations between participant variables and VR Training results will be explored. If the proposed hypothesis is supported and results show that training effects generalize from virtual to real tasks in the study sample, then VR training of custom and individualized tasks will be investigated in a future randomized, controlled clinical trial for maintaining and improving functional abilities in people with mild to moderate AD.

Conditions

Alzheimer Disease; Mild Dementia; Mild Cognitive Impairment; Dementia; Dementia, Vascular; Dementia Alzheimers; Dementia, Mild; Dementia, Mixed; Dementia of Alzheimer Type

Outcome Measures

Primary Outcomes (8)

• Real Trained Task Performance- Accomplishment

  The number of task steps accomplished out of 16 possible steps; also may be reported as the number of task steps omitted (omission errors)

  1 day post- training (immediate)

• Real Trained Task Performance- Accomplishment

  The number of task steps accomplished out of 16 possible steps; also may be reported as the number of task steps omitted (omission errors)

  1 month post-training

• Real Trained Task Performance- Overt Commission Errors

  The number total overt commission errors; may be characterized as a raw total or as an error rate measure (by dividing by total number of steps completed) to control for variability in the number of steps accomplished.

  1 day post- training (immediate)

• Real Trained Task Performance- Overt Commission Errors

  The number total overt commission errors; may be characterized as a raw total or as an error rate measure (by dividing by total number of steps completed) to control for variability in the number of steps accomplished.

  1 month post-training

• Real Trained Task Performance- Micro-errors

  The number total subtle errors coded; may be characterized as a raw total or as a micro-error rate measure (by dividing by total number of steps completed) to control for variability in the number of steps accomplished.

  1 day post- training (immediate)

• Real Trained Task Performance- Micro-errors

  The number total subtle errors coded; may be characterized as a raw total or as a micro-error rate measure (by dividing by total number of steps completed) to control for variability in the number of steps accomplished.

  1 month post-training

• Real Trained Task Performance- Completion Time

  The total time (in seconds) required to complete the task; may be characterized as a raw time or as a rate of completion measure (by dividing by total time by number of steps completed) to control for variability in the number of steps accomplished.

  1 day post- training (immediate)

• Real Trained Task Performance- Completion Time

  The total time (in seconds) required to complete the task; may be characterized as a raw time or as a rate of completion measure (by dividing by total time by number of steps completed) to control for variability in the number of steps accomplished.

  1 month post-training

Secondary Outcomes (2)

• Virtual Reality Training Acceptability

  1day post-training

• Virtual Reality Training Usability

  1 day post-training

Study Arms (2)

Virtual Training Arm

EXPERIMENTAL

This is a within-participant study with two arms. All participants receive the Virtual Training with one target task and they are tested (after one day and one month) on the target task (arm 1) and as well as on a control task(arm 2). Assignment to the specific task that is trained is randomized across participants.

Behavioral: Virtual Kitchen Training

Control Arm

NO INTERVENTION

This is a within-participant study with two arms. All participants receive the Virtual Training with one target task and they are tested (after one day and one month) on the target task (arm 1) and as well as on a control task(arm 2). Assignment to the specific task that is trained is randomized across participants.

Interventions

Virtual Kitchen Training BEHAVIORAL

VR Training will include repeated practice of a single, everyday task in a non-immersive VR context (e.g., VR Breakfast) using a laptop with a touch-screen interface for four days over the course of one week.

Also known as: Virtual Training

Virtual Training Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• years or older;
• fluency in the English language;
• availability of an informant reporter who has knowledge of the participant's daily functioning;
• no lifetime history of severe psychiatric disorder (e.g., schizophrenia, bipolar disorder), nervous system infections or disorders (e.g., epilepsy, brain tumor, large-vessel stroke, major head trauma) other than Alzheimer's disease;
• no current metabolic or systemic disorders (e.g., B12 deficiency, renal failure, cancer);
• no current major depression or moderate-severe depression symptoms;
• no current moderate - severe, uncontrolled anxiety symptoms;
• no severe sensory deficits that would preclude visual detection or identification of common everyday objects used in the study or the inability to hear the task directions (e.g., blindness, total hearing loss);
• no severe motor weakness that would preclude the use of everyday objects or the VR Training computer touch screen (e.g., severe deformities or paralysis of both upper extremities) ;
• intact estimated general intellectual functioning (i.e., no history of intellectual disability);
• available to participate in the one-month follow-up session after the VR Training (i.e., no surgery, travel, etc. scheduled over the next month);
• diagnosis of mild to moderate Alzheimer's disease within the past year, including confirmation of mild to moderate dementia on Mini Mental Status Exam (score approximately 25 or lower), significant functional difficulties reported by informant report, and cognitive impairment on demographically adjusted (age, education, sex, and race) cognitive test scores at baseline.
• An informant (N = 40) also will be recruited for each participant with dementia. Informants are people who know the participant well and interact with the participant on a daily basis. Informants will be asked to report on the participants' daily functioning and the extent to which the informant is burdened by the participants. Informants also will be asked to report on changes in medical or mental status during the study period. Informant eligibility criteria is listed below:
• years of age or older
• fluency in the English language

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19121, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia; Dementia, Vascular; Lymphoma, Follicular; Mixed Dementias

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor is blind to participants' study condition.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention is task specific. Participants are given an intervention for a specific task, and outcomes include the specific task for which they received the intervention (i.e., "trained task), as well as a control task for which they do not receive the intervention.

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 19, 2020
• Study Start: January 12, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication of the study results; indefinitely.

Locations

US (1)