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

Sponsor

Indiana University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05601817

Collaborator

National Institute on Aging (NIA) (NIH)

172

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Mild Cognitive Impairment	Behavioral: Vita Behavioral: Com Behavioral: Vita+Com	N/A

Detailed Description

Heart failure (HF) and mild cognitive impairment (MCI) are prevalent among older adults in the U.S. Patients with HF are twice as likely to have MCI than people without HF. Cognitive impairment in HF is associated with significant decline in one's ability to take care of one's self and higher 12-month mortality. A small number of cognitive interventions have demonstrated preliminary efficacy in improving cognitive function in HF. However, this work suffers from some major limitations: 1) lack of focus on patients who already have cognitive impairments and at higher risk of dementia; 2) focus on single-component interventions; 3) lack of evaluation of responsiveness variables including genetic biomarkers; and 4) lack of long-term follow-up. Dr. Miyeon Jung, PhD, RN proposes to address this gap by conducting a randomized controlled pilot trial to estimate the preliminary efficacy of a virtual reality-based cognitive restoration (Vita) combined with a computerized cognitive training intervention (Com) relative to each intervention alone and standard of care among 172 older HF patients with MCI. The Specific aims of the project are to estimate the effects of the Vita and Com interventions individually and in combination to improve: 1) attention and memory (Aim 1); 2) HF self-care, instrumental activities of daily living, and health-related quality of life (Aim 2); and 3) dementia free survival (Aim 3) over 1 year. An exploratory aim is to examine moderating factors that may influence intervention efficacy (i.e., baseline cognitive function, depressive symptoms, HF severity, and presence of apolipoprotein E ε4 and BDNF Met allele).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

172 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

A 2 by 2 factorial designA 2 by 2 factorial design

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Single-blind

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
Experimental: 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.	Behavioral: 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.
No 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.

Outcome Measures

Primary Outcome Measures

Changes in cognitive function: attention [Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline]
Trail Making and Number Span Test from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)
Changes in cognitive function: memory [Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline]
Craft Story 21 and Benson Figure Copy for memory from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)

Secondary Outcome Measures

Changes in heart failure self-care [Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline]
Self-Care of Heart Failure Index
Changes in instrumental activities of daily living [Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline]
Functional Activities Questionnaire (for both patients and informants)
Changes in instrumental activities of daily living [Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline]
Everyday Problems Test (performance-based, for patient only)
Changes in health-related quality of life [Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline]
Minnesota Living with Heart Failure Questionnaire
Dementia-free survival [1 year after baseline]
Survival status (alive or deceased) at year collected from electronic health records

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

We will use a two-step process to screen and enroll the patients. First, we will screen potentially eligible patients from the Indiana University Health systems using these eligibility criteria.

Inclusion Criteria:

≥ 65 years;
chronic HF Stage C validated from echocardiography or comparable measure;
ability to communicate in English;
a someone (e.g., family member, significant other, close friend) who agrees to serve as an informant and provide information of the patient's IADL; and
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.

Exclusion Criteria:

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.