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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05601817
• Other study ID #: 15739
• Secondary ID: 1K76AG074940-01A
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: Miyeon Jung, PhD, RN
• Phone: 317-274-4360
• Email: miyjung[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Heart Failure
• Mild Cognitive Impairment

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cognitive function: attention	Trail Making and Number Span Test from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)	Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Primary	Changes in cognitive function: memory	Craft Story 21 and Benson Figure Copy for memory from National Alzheimer's Coordinating Center Neuropsychological battery (Uniform Data Set V3.0)	Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Secondary	Changes in heart failure self-care	Self-Care of Heart Failure Index	Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Secondary	Changes in instrumental activities of daily living	Functional Activities Questionnaire (for both patients and informants)	Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Secondary	Changes in instrumental activities of daily living	Everyday Problems Test (performance-based, for patient only)	Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Secondary	Changes in health-related quality of life	Minnesota Living with Heart Failure Questionnaire	Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Secondary	Dementia-free survival	Survival status (alive or deceased) at year collected from electronic health records	1 year after baseline