A Virtual Reality Intervention to Improve Attention in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Changes in attention - Multi-Source Interference Task
研究概览
简要总结
Heart failure is a prevalent and serious public health concern with the growing aging population. Patients with heart failure often experience attention impairment that decreases their ability to perform self-care and diminishes their health-related quality of life. In past studies, 15 - 27% of heart failure patients had attention impairment. Attention is fundamental to human activities including self-care management of heart failure. However, cognitive interventions focusing on attention are scarce in heart failure literature. This study focuses on developing a novel cognitive intervention specifically targeting improved attention and testing its efficacy on improving attention, self-care, and health-related quality of life.
The investigators in this study are asking the following 3 questions: 1) does the newly developed cognitive intervention using immersive virtual reality technology (Nature-VR) improve attention compared with the control condition (Urban-VR)?; 2) does Nature-VR intervention improve HF self-care and health-related quality of life compared with Urban-VR control condition?; and 3) are selected biological factors associated with attention function in HF?
The virtual reality-based cognitive intervention (Nature-VR) can be an efficacious intervention for the patients to use and enjoy without burdening already reduced attention. This study has great potential to improve attention and prevent attention impairment, thereby leading to healthier lives among heart failure patients.
详细描述
Heart failure (HF) is a prevalent serious chronic illness that affects 6.5 million American. Among HF patients, prevalence of attention impairment is reported as 15-27%. Attention is fundamental to human activities including HF self-care. However, cognitive interventions focusing on attention are scarce in HF. The investigators developed a new cognitive intervention with immersive virtual reality technology and created a prototype of the virtual reality-based natural restorative environment intervention (Nature-VR). The prototype was feasible and showed larger effects in improving attention among 10 HF patients.
In this 2-group randomized controlled pilot study, specific aims are to: 1) examine preliminary efficacy of Nature-VR compared with Urban-VR on improving attention; 2) examine preliminary efficacy of Nature-VR compared with Urban-VR on HF self-care and health-related quality of life; and 3) explore possible biomarkers of attention in HF. This study is important and novel because this is the first intervention study targeting attention using virtual reality technology and investigating possible biomarkers associated with attention in HF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults (> 21 years)
- •diagnosed with chronic HF Stage C
- •able to communicate in English
排除标准
- •uncorrected visual impairment
- •major neurological disease (e.g., Alzheimer disease, Parkinson's disease)
- •major psychiatric disease (e.g., schizophrenia, bipolar disease)
研究组 & 干预措施
Nature-VR
Viewing 3D pictures of natural environments
干预措施: Nature-VR (Other)
Urban-VR
Viewing 3D pictures of urban environments
干预措施: Urban-VR (Other)
结局指标
主要结局
Changes in attention - Multi-Source Interference Task
时间窗: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Performances on the computerized cognitive test of Multi-Source Interference Task will be examined in terms of speed and accuracy. Participants are instructed to identify the target number, which is different than the other 3 numbers provided on the computer screen. There are two types of trials, congruent and incongruent. Congruent trials have a target number that is always matched its position on the button (e.g., 100, 020, or 223), in contrast, incongruent trials have the target number that is never matched with it position in the button (e.g., 010, 233, or 232). Faster response time and lower error rates indicate better attention.
Changes in attention - Digit Span Test
时间窗: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Participants are instructed to remember the sequence of numbers the data collector told and repeat the numbers right after the instructor finished talking. This test has 2 subsets, Forward-repeat exactly the same sequence, and Backward-repeat the numbers in the backward from last to the first. More digits correctly repeated indicate better attention.
Changes in attention - Stroop Test
时间窗: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
Stroop Test is a color-word test measuring the ability to processe different visual features and ignore distractions. The test has 2 parts of reading letters of color names and colors of color names using 4 color names (i.e., red, blue, yellow, and green). Congruent trials have the same letters and colors of the color names (i.e., red in red color). Incongruent trials have different letters and colors of the color names (i.e., red in blue color). Faster response time and lower error rates indicate better attention.
Changes in attention - Attentional Function Index
时间窗: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
This self-reported questionnaire has 13 items on 0 to 10 response scales asking effectiveness in behaviors requiring attention. Higher scores indicate better subjective attention
Changes in attention - Trail Making Test
时间窗: Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks
This traditional cognitive test of attention is a paper-pencil based measure and has 2 parts. Part A requires participants to connect a series of randomly arrayed, distinct circles numbered 1 to 25 in correct order as quickly as possible. Part B requires participants to connect a series of 25 circles numbered 1 to 13 randomly intermixed with letters from A to L, alternating between numbers and letters, and proceeding in ascending order (e.g., 1-A-2-B-3 and so on). Faster response time in seconds indicates better attention.
次要结局
- Changes in the Self-Care of Heart Failure Index (SCHFI)(Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks)
- Changes in Minnesota Living with Heart Failure Questionnaire (LHFQ)(Baseline, 4 weeks, 8 weeks, 26 weeks, and 52 weeks)
研究者
Miyeon Jung
Assistant Professor
Indiana University