Indiana University
Indianapolis, Indiana, 46202, United States
NCT Number: NCT05601817
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.
This study is active but is not currently recruiting participants.
Notify Me55 year and older
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
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).
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
Exclusion criteria
Second, we will enroll patients only if they have MCI or normal cognition by not meeting criteria for dementia.
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 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 intervention is a combination of both Vita and Com interventions. Participants will be asked to complete Vita first and then Com intervention.
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)
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)
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Self-Care of Heart Failure Index
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Functional Activities Questionnaire (for both patients and informants)
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Everyday Problems Test (performance-based, for patient only)
Time frame: Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline
Minnesota Living with Heart Failure Questionnaire
Time frame: 1 year after baseline
Survival status (alive or deceased) at year collected from electronic health records
Indiana University
Other
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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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