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NCT Number: NCT05601817

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • ≥ 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?".

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.

Second, we will enroll patients only if they have MCI or normal cognition by not meeting criteria for dementia.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Changes in cognitive function: attention

    Time frame: 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)

  2. Changes in cognitive function: memory

    Time frame: 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 outcomes

  1. Changes in heart failure self-care

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

    Self-Care of Heart Failure Index

  2. Changes in instrumental activities of daily living

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

    Functional Activities Questionnaire (for both patients and informants)

  3. Changes in instrumental activities of daily living

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

    Everyday Problems Test (performance-based, for patient only)

  4. Changes in health-related quality of life

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

    Minnesota Living with Heart Failure Questionnaire

  5. Dementia-free survival

    Time frame: 1 year after baseline

    Survival status (alive or deceased) at year collected from electronic health records

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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