Clinical trial NCT05601817: Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure
Official title: Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Mild Cognitive Impairment
Keywords: heart failure
mild cognitive impairment
older adults
cognitive intervention
cognitive training
attention restoration
virtual reality
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-11-01
Enrollment: 172
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A 2 by 2 factorial design
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Changes in cognitive function: attention
timeFrame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
measure: Changes in cognitive function: memory
timeFrame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Secondary outcomes:
measure: Changes in heart failure self-care
timeFrame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
measure: Changes in instrumental activities of daily living
timeFrame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
measure: Changes in instrumental activities of daily living
timeFrame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
measure: Changes in health-related quality of life
timeFrame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
measure: Dementia-free survival
timeFrame: 1 year after baseline
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References: