Using virtual reality and cognitive training to help older adults with heart failure and memory issues
Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure
This study tests if using virtual reality and computer exercises can help older adults with heart failure and memory problems feel better and improve their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05601817 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of a dual-component intervention that combines virtual reality-based cognitive restoration and computerized cognitive training for older adults suffering from heart failure and mild cognitive impairment. The study will involve 172 participants who will be randomly assigned to receive either one of the interventions, both, or standard care. The primary focus is to improve cognitive function, self-care abilities, and overall quality of life over a one-year period. Additionally, the study will explore factors that may influence the effectiveness of these interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults aged 55 and above with chronic heart failure and subjective cognitive concerns.
Not a fit: Patients with advanced heart failure or major neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance cognitive function and quality of life for older adults with heart failure and mild cognitive impairment.
How similar studies have performed: While some cognitive interventions have shown preliminary efficacy in heart failure patients, this specific dual-component approach is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Indianapolis, Indiana
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Miyeon Jung, PhD, RN
- Email: miyjung@iu.edu
- Phone: 317-274-4360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.