Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure
NCT ID: NCT05601817
Last Updated: 2025-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
172 participants
INTERVENTIONAL
2023-04-18
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Vita (virtual reality-based cognitive restoration intervention)
Participants randomized to Vita will receive a virtual reality head-mount device (e.g., Oculus Quest) to view nature pictures for 10 minutes (1 set of 10 pictures)/day, 2-3 days/week for 8 weeks (a total of 20 sets for 200 minutes, approximately 3.3 hours) based on the provided activity schedule. Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.
Vita
Vita is developed by this study team based on Attention Restoration Theory. The Vita intervention involves viewing 360 degree nature pictures on a virtual reality headset.
Com (computerized cognitive training intervention )
Participants randomized to Com will receive a tablet computer (e.g., iPad) to complete BrainHQ training for 1 hour (6 exercises)/day, 2-3 days/week for 8 weeks (total of 20 hours) based on the provided activity schedule. Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.
Com
Com intervention uses BrainHQ from PositScience that was developed based on the brain neuroplasticity. The com intervention involves doing game-like training on a iPad.
Vita+Com (Both Vita and Com intervention)
Participants randomized to Vita+Com will receive both Vita and Com simultaneously. They will spend 10 minutes on Vita and then 1 hour on Com per day, 2-3 days/week for 8 weeks (a total of 23.3 hours). Participants will receive weekly check-in calls from the intervention RA during the 8 weeks of intervention phase.
Vita+Com
Vita+Com intervention is a combination of both Vita and Com interventions. Participants will be asked to complete Vita first and then Com intervention.
Usual care
Participants randomized to this control condition will continue to receive their usual care, but no interventions from the study team. We will monitor changes in their activities that may affect changes in cognitive function (e.g., starting book clubs) by weekly check-in calls during the 8 weeks of intervention phase.
No interventions assigned to this group
Interventions
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Vita
Vita is developed by this study team based on Attention Restoration Theory. The Vita intervention involves viewing 360 degree nature pictures on a virtual reality headset.
Com
Com intervention uses BrainHQ from PositScience that was developed based on the brain neuroplasticity. The com intervention involves doing game-like training on a iPad.
Vita+Com
Vita+Com intervention is a combination of both Vita and Com interventions. Participants will be asked to complete Vita first and then Com intervention.
Eligibility Criteria
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Inclusion Criteria
2. chronic HF Stage C validated from echocardiography or comparable measure or B-type natriuretic peptide (BNP) level \> 400 pg/ml \[or equivalent NT-proBNP\] in past 3 years;
3. ability to communicate in English;
4. capacity to consent according to the Indiana University Institutional Review Board policies, or lacks capacity to consent but has the ability to provide assent from someone who can serve as LAR; and
5. Subjectively reported cognitive concern assessed by the question, "Do you have any trouble with your memory or thinking?".
Exclusion Criteria
2. vision or hearing problems that can interfere with cognitive testing;
3. major neurological disorder (e.g., previously diagnosed dementia, Parkinson's disease, epilepsy, multiple sclerosis);
4. major psychiatric disease (e.g., schizophrenia, bipolar disorder);
5. life-threatening unstable illness other than HF (e.g., end-stage cancer); and
6. users of regular computerized cognitive training or participants in cognitive training trials in the past year.
Second, we will enroll patients only if they have MCI or normal cognition by not meeting criteria for dementia.
55 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Indiana University
OTHER
Responsible Party
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Miyeon Jung
Assistant Professor
Locations
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Indiana University
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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Miyeon Jung
Role: primary
Other Identifiers
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15739
Identifier Type: -
Identifier Source: org_study_id
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