NCT05601817

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Heart Failure
• Mild Cognitive Impairment

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2023-04-03
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2022-11-01
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States