Virtual Reality and Computerized Cognitive Intervention for Mild Cognitive Impairment in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Changes in cognitive function: attention
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Single-blind
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •≥ 55 years;
- •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;
- •ability to communicate in English;
- •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
- •Subjectively reported cognitive concern assessed by the question, "Do you have any trouble with your memory or thinking?".
排除标准
- •pre-HF (Stages A and B) or advanced HF (Stage D);
- •vision or hearing problems that can interfere with cognitive testing;
- •major neurological disorder (e.g., previously diagnosed dementia, Parkinson's disease, epilepsy, multiple sclerosis);
- •major psychiatric disease (e.g., schizophrenia, bipolar disorder);
- •life-threatening unstable illness other than HF (e.g., end-stage cancer); and
- •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.
结局指标
主要结局
Changes in cognitive function: attention
时间窗: 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
时间窗: 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)
次要结局
- Dementia-free survival(1 year after baseline)
- Changes in health-related quality of life(Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline)
- Changes in heart failure self-care(Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline)
- Changes in instrumental activities of daily living(Baseline, 8 weeks, 16 weeks, and 1 year (52 weeks) after baseline)
研究者
Miyeon Jung
Assistant Professor
Indiana University