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Behavioural Intervention

Virtual Reality + Cognitive Training for Mild Cognitive Impairment

N/A

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 55 years

Chronic HF Stage C validated from echocardiography or comparable measure

Must not have

Major neurological disorder (e.g., previously diagnosed dementia, Parkinson's disease, epilepsy, multiple sclerosis)

Life-threatening unstable illness other than HF (e.g., end-stage cancer)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the health, quality of life, and survival of older adults with heart failure and cognitive impairment by testing a dual-component intervention.

Who is the study for?

This trial is for adults over 55 with heart failure (Stage C) and mild cognitive issues, like memory or concentration problems. They must speak English and have someone to report on their daily activities. It's not for those with advanced heart failure, significant vision/hearing issues, major neurological/psychiatric conditions, life-threatening illnesses besides heart failure, or recent cognitive training.

What is being tested?

The study tests a two-part treatment combining virtual reality-based cognitive restoration and computerized brain exercises to improve thinking skills and overall health in older adults with both heart failure and mild cognitive impairment.

What are the potential side effects?

Since the interventions involve virtual reality experiences and computerized tasks designed to stimulate the brain, side effects might include discomfort from wearing VR headsets such as eye strain or dizziness but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 55 years old or older.

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My heart failure is at Stage C, confirmed by an echo test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a major neurological disorder like dementia or Parkinson's.

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I do not have a life-threatening illness other than heart failure.

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My heart failure is either at an early stage or very advanced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight Changes

Cognition

Secondary study objectives

Changes in health-related quality of life

Heart failure

Changes in instrumental activities of daily living

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Vita+Com (Both Vita and Com intervention)Experimental Treatment1 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.

Group II: Vita (virtual reality-based cognitive restoration intervention)Experimental Treatment1 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.

Group III: Com (computerized cognitive training intervention )Experimental Treatment1 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.

Group IV: Usual careActive Control1 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.

0 / 5Eligibility criteria met