Digital Fall Prevention Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Acceptability and adherence to exercise program
研究概览
简要总结
The Digital Fall Prevention Study is a single-group unblinded study to explore the feasibility and acceptability of a 3-month fall prevention exercise program delivered digitally via a tablet interface. Evidence-based exercise programs and motivational techniques will be used along with new wearable technology to predict fall risk.
详细描述
The goal of this study is to demonstrate the feasibility and acceptability of a digital fall prevention exercise program and to explore whether there is benefit from participating in such programs. This study will include 30 older adults who are at higher risk of falling or have a fear of falling and living at home. All participants will receive the intervention. All participants will be assessed pre- and post-intervention on measures of sensor-based fall risk, sensor-based frailty, falls self-efficacy, technology readiness, feasibility and acceptability, utilization and participation, frailty, grip strength, depression, anxiety, and physical activity (both self-report and using wearable sensors).
The overall hypothesis is that a prototype system consisting of wearable sensors and a tablet will be feasible and acceptable in a population of older adults with increased risk for falls and fall-related injuries or with a fear of falling.
Aim 1: To determine the feasibility and acceptability of a self-guided, digitally delivered, in-home exercise program for older adults with elevated fall risk.
- Hypothesis 1a): The technology (wearable sensor and tablet) and digitally delivered fall prevention exercises will be feasible and acceptable to older people at risk for falls.
- Hypothesis 1b): The technology (wearable sensor and tablet) and digitally delivered fall prevention exercise program will reduce a user's concern of falling
Aim 2: To determine the clinical effects of implementing a fall prevention intervention program via the remote platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and females who are 65 years or older
- •Short Physical Performance Battery (SPPB)7 ≥ 5
- •the Montreal Cognitive Assessment (MoCA)8 > 17
- •Increased risk for falls based on a self-reported answer of yes to one or more of these questions:
- •Have you fallen and hurt yourself in the past year?
- •Have you fallen two or more times in the past year?
- •Are you afraid that you might fall because of balance or walking problems?
- •Access to Wi-Fi in their home (or willingness to use cellular service if provided)
排除标准
- •Unable or unwilling to provide informed consent
- •MI, acute coronary syndrome, revascularization surgery, or stroke in the last 6 months
- •Chest pain or untreated/uncontrolled CVD
- •Hip/knee fracture/replacement or spinal surgery in past 6 months
- •Pulmonary decompensation that would prevent participation in the exercise program
- •Planned orthopedic surgery that would limit participation in the study
- •Planned to be away from tablet access for > 7 days during the length of the study
- •Unable to attend in-person pre- or post-study clinic visit
- •Enrolled in a formal exercise program and/or physical therapy that takes place 3 or more times per week
- •Vision or hearing impairments that would make it difficult to participate in the intervention
- •Non-English speaking or other language limitations that would make it difficult to participate in the intervention
- •Reside in a nursing home
- •Unable to walk independently (with or without a walking aid)
- •Not appropriate for study based on clinician exam or discretion (clinician will specify reason)
研究组 & 干预措施
Digital Fall Prevention
Subjects will participate in Digital Fall Prevention intervention for 12 weeks
干预措施: Digital Fall Prevention (Combination Product)
结局指标
主要结局
Acceptability and adherence to exercise program
时间窗: over the 12 weeks of the intervention
Percentage of scheduled exercise sessions complete (70% of sessions completed = acceptable adherence)
Fall Efficacy Scale - International (FES-I)
时间窗: change from baseline to 12-weeks
fear of falling measure, score range from 16-64, higher score=less fear of falling
Acceptability of Intervention Measure (AIM)
时间窗: at final (12-week) assessment
a self-report measure of acceptability of the intervention, score range is 1-5, higher score = greater acceptability
Feasibility of Intervention Measure (FIM)
时间窗: at final (12-week) assessment
a self-report measure of the intervention feasibility, score range is 1-5, higher score = greater feasibility
Intervention Appropriateness Measure (IAM)
时间窗: at final (12-week) assessment
a self-report measure of the intervention appropriateness, score range is 1-5, higher score = greater appropriateness
次要结局
- Grip Strength of dominant hand(change from baseline to 12-weeks)
- Sensor based frailty assessment(change from baseline to 12-weeks)
- Fried Frailty Index (FFI)(change from baseline to 12-weeks)
- Physical Activity Scale for the Elderly (PASE)(change from baseline to 12-weeks)
- Montreal Cognitive Assessment (MoCA)(change from baseline to 12-weeks)
- Digit Symbol Substitution Test(change from baseline to 12-weeks)
- Sensor based fall risk assessment(change from baseline to 12-weeks)
- Short Physical Performance Battery (SPPB)(change from baseline to 12-weeks)
- Technology Acceptance Model (TAM)(at final (12-week) assessment)
研究者
Nancy Latham
Clinical Research Director, Research Division of Men's Health, Aging and Metabolism
Brigham and Women's Hospital