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Improving Everyday Task Performance Through Repeated Practice in Virtual Reality. (VKI)

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ClinicalTrials.gov Identifier: NCT04315337
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Mild Dementia Mild Cognitive Impairment Dementia Dementia, Vascular Dementia Alzheimers Dementia, Mild Dementia, Mixed Dementia of Alzheimer Type Behavioral: Virtual Kitchen Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessor is blind to participants' study condition.
Primary Purpose: Treatment
Official Title: Improving Everyday Task Performance Through Repeated Practice in Virtual Reality.
Actual Study Start Date : January 12, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual Training Arm
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
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.
Other Name: Virtual Training

No Intervention: Control Arm
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.



Primary Outcome Measures :
  1. Real Trained Task Performance- Accomplishment [ Time Frame: 1 day post- training (immediate) ]
    The number of task steps accomplished out of 16 possible steps; also may be reported as the number of task steps omitted (omission errors)

  2. Real Trained Task Performance- Accomplishment [ Time Frame: 1 month post-training ]
    The number of task steps accomplished out of 16 possible steps; also may be reported as the number of task steps omitted (omission errors)

  3. Real Trained Task Performance- Overt Commission Errors [ Time Frame: 1 day post- training (immediate) ]
    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.

  4. Real Trained Task Performance- Overt Commission Errors [ Time Frame: 1 month post-training ]
    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.

  5. Real Trained Task Performance- Micro-errors [ Time Frame: 1 day post- training (immediate) ]
    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.

  6. Real Trained Task Performance- Micro-errors [ Time Frame: 1 month post-training ]
    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.

  7. Real Trained Task Performance- Completion Time [ Time Frame: 1 day post- training (immediate) ]
    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.

  8. Real Trained Task Performance- Completion Time [ Time Frame: 1 month post-training ]
    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.


Secondary Outcome Measures :
  1. Virtual Reality Training Acceptability [ Time Frame: 1day post-training ]
    Participant is asked open-ended questions about the burden the Virtual Training had on their daily life and how likely they would be to adopt the virtual training in their day-to-day life.

  2. Virtual Reality Training Usability [ Time Frame: 1 day post-training ]
    The System Usability Scale includes 10 items evaluated on a 1 (strongly disagree) - 5 (strongly agree) point scale. After correction (-1 for odd items and -5 for even, reverse-scored items), the total is multiplied by 2.5 to yield a total score ranging from 0 (poor usability) to 100 (excellent usability). The investigators also added a single seven-point adjective rating question regarding the usability of the Training (1 = worst imaginable to 7 = best imaginable) at the end of the questionnaire to facilitate interpretation.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion Criteria:

  1. 65 years or older;
  2. fluency in the English language;
  3. availability of an informant reporter who has knowledge of the participant's daily functioning;
  4. 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;
  5. no current metabolic or systemic disorders (e.g., B12 deficiency, renal failure, cancer);
  6. no current major depression or moderate-severe depression symptoms;
  7. no current moderate - severe, uncontrolled anxiety symptoms;
  8. 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);
  9. 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) ;
  10. intact estimated general intellectual functioning (i.e., no history of intellectual disability);
  11. 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);
  12. 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:

  1. 18 years of age or older
  2. fluency in the English language
  3. available and willing to complete study questionnaires in person or by phone
  4. has daily contact with the participant
  5. reports that he/she is knowledgeable of the participant's daily functioning

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04315337


Contacts
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Contact: Tania Giovannetti, PhD 215-204-4296 tgio@temple.edu

Locations
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United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19121
Contact: Tania Giovannetti, Ph.D.    215-204-4296    tgio@temple.edu   
Sponsors and Collaborators
Temple University
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT04315337    
Other Study ID Numbers: AG066771
First Posted: March 19, 2020    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators will present preliminary and final data at scientific conferences and lectures at research centers, clinical settings, and senior centers. The study results will be publish. The Virtual Kitchen that is used for the training in this proposal is freely available to scientists who are interested in using it. Currently, investigators simply need to contact members of the study team to attain the program. The investigators will make the final training version of the Virtual Kitchen available for download on a website after procedures are fully manualized. After data collection is complete and the results of the aims are published, then the investigators intend to make the entire de-identified data set available following guidelines available through the Center for Open Science.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: After publication of the study results; indefinitely.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Dementia, Vascular
Cognitive Dysfunction
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