Heart Failure, Mild Cognitive Impairment
Conditions
Keywords
heart failure, mild cognitive impairment, older adults, cognitive intervention, cognitive training, attention restoration, virtual reality
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).
Interventions
BEHAVIORALVita
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.
BEHAVIORALCom
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.
BEHAVIORALVita+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.
Sponsors
Indiana University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Single-blind
Intervention model description
A 2 by 2 factorial design
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in heart failure self-care | Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline | Self-Care of Heart Failure Index |
| Changes in instrumental activities of daily living | Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline | Functional Activities Questionnaire (for both patients and informants) |
| 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 |
| Dementia-free survival | 1 year after baseline | Survival status (alive or deceased) at year collected from electronic health records |
Countries
United States
Outcome results
None listed