Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure

NCT05601817 | Active Not Recruiting DMC

• 2 other identifiers: 157391K76AG074940-01A1
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This research project is relevant to public health because both heart failure (HF) and mild cognitive impairment (e.g., trouble remembering and concentrating beyond normal aging) are highly prevalent among older adults in the United States. Despite advances in health care, there are no effective interventions for treating cognitive impairment in HF, which if left untreated, leads to suboptimal health, quality of life, and shorter survival. Therefore, the investigators propose to test the effect of a dual-component intervention comprised of a virtual reality-based cognitive restoration intervention and computerized cognitive training on cognitive function and overall health among 172 older adults with HF who experience mild cognitive impairment.

Conditions

Heart Failure; Mild Cognitive Impairment

Keywords

heart failure; mild cognitive impairment; older adults; cognitive intervention; cognitive training; attention restoration; virtual reality

Outcome Measures

Primary Outcomes (2)

• Changes in cognitive function: attention

  Trail Making and Number Span Test from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)

  Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline

• Changes in cognitive function: memory

  Craft Story 21 and Benson Figure Copy for memory from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)

  Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline

Secondary Outcomes (5)

• Changes in heart failure self-care

  Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline

• Changes in instrumental activities of daily living

  Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline

• Changes in instrumental activities of daily living

  Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline

• Changes in health-related quality of life

  Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline

• Dementia-free survival

  1 year after baseline

Study Arms (4)

Vita (virtual reality-based cognitive restoration intervention)

EXPERIMENTAL

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.

Behavioral: Vita

Com (computerized cognitive training intervention )

EXPERIMENTAL

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.

Behavioral: Com

Vita+Com (Both Vita and Com intervention)

EXPERIMENTAL

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.

Behavioral: Vita+Com

Usual care

NO INTERVENTION

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.

Interventions

Vita BEHAVIORAL

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.

Vita (virtual reality-based cognitive restoration intervention)

Com BEHAVIORAL

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.

Com (computerized cognitive training intervention )

Vita+Com BEHAVIORAL

Vita+Com intervention is a combination of both Vita and Com interventions. Participants will be asked to complete Vita first and then Com intervention.

Vita+Com (Both Vita and Com intervention)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 55 years;
• 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;
• ability to communicate in English;
• 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
• Subjectively reported cognitive concern assessed by the question, "Do you have any trouble with your memory or thinking?".

You may not qualify if:

• pre-HF (Stages A and B) or advanced HF (Stage D);
• vision or hearing problems that can interfere with cognitive testing;
• major neurological disorder (e.g., previously diagnosed dementia, Parkinson's disease, epilepsy, multiple sclerosis);
• major psychiatric disease (e.g., schizophrenia, bipolar disorder);
• life-threatening unstable illness other than HF (e.g., end-stage cancer); and
• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Heart Failure; Cognitive Dysfunction

Interventions

Vitamin A; Mesna

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A 2 by 2 factorial design

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 1, 2022
• Study Start: April 3, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)