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

Not Applicable

Recruiting

• Conditions: Heart Failure; Mild Cognitive Impairment
• Interventions: Behavioral: Vita+Com; Behavioral: Vita; Behavioral: Com

• Registration Number: NCT05601817
• Lead Sponsor: Indiana University

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.

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 Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-01
• Study Start: 2023-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

1. ≥ 55 years;
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

1. pre-HF (Stages A and B) or advanced HF (Stage D);
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Vita+Com (Both Vita and Com intervention)	Vita+Com	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 (virtual reality-based cognitive restoration intervention)	Vita	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.
Com (computerized cognitive training intervention )	Com	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
Dementia-free survival	1 year after baseline	Survival status (alive or deceased) at year collected from electronic health records
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
Changes in heart failure self-care	Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline	Self-Care of Heart Failure Index

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States