SAIF: An End-to-end System for Assessment and Intervention of Frailty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty
研究概览
简要总结
The study aims to evaluate the feasibility and effectiveness of using SAIF (an end-to-end System for Assessment and Intervention of Frailty) to reduce the risk and delay the progress of physical frailty.
详细描述
SAIF is a personalised, community-based system for both assessment and intervention of frailty. It comprises of 8 modules categorised into
- Interface: virtual nurse and caregiver gateway
- Assessment: computerised screening using Fried Frailty Phenotype (FFP) and FRAIL instruments, Gamified Walking While Talking to assess frailty status and predictive analytics to predict participant's frailty risk
- Intervention: Physical exercise kiosks (Cycling and Taichi) incorporated with games, polypharmacy management and nutrition recommendation
A total of 105 eligible community-dwelling older adults were recruited and randomised either to control arm or intervention arm using a single-consent Zelen's design. Allocation concealment was achieved using permutated block randomisation; both research assistant and participant were blinded to randomisation list during enrolment.
All participants completed baseline assessment and subsequent follow-up assessments (2-month, 4-month and 7-month). Additionally, participants in the intervention arm began SAIF interaction for a period of 4 months upon completion of their baseline assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 and above
- •CFS 4 or 5 / CFS 3 with FRAIL score at least 1 / CFS 3 with FPQ score at least 1
- •Ambulate for at least 10m without walking aid
- •English and/or Mandarin speaking
排除标准
- •Known diagnosis of dementia or CMMSE score <19
- •Parkinson's disease
- •Hip surgery within the last 6 months
- •Presence of end-stage organ failure, symptomatic heart conditions or COPD
- •Active arthritis
- •Hospitalisation within the last 1 month
- •Participants who are unable to provide consent
结局指标
主要结局
Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty
时间窗: 7 months
CFS is a 9-point validated clinical assessment tool to evaluate frailty and fitness of an older adult. Domains of scale includes functions, comorbidities and cognition. Score on scale can classify participant's fitness into categories: very fit (CFS 1), well (CFS 2), managing well (CFS 3), vulnerable (CFS 4), mildly frail (CFS 5), moderately frail (CFS 6), severely frail (CFS 7), severely frail (CFS 8) and terminally ill (CFS 9).
Change in physical performance scored based on Short Physical Performance Battery (SPPB)
时间窗: 7 months
SPPB is an assessment tool that evaluates function in older adults based on total score derived from measurement of gait speed, balance and chair stand tests. SPPB instrument has a score range of 0 (worst performance) to 12 (best performance).
Change in frailty scores as measured by Fried Frailty Phenotype (FFP)
时间窗: 7 months
FFP consists of 5 physical criteria: exhaustion, slowness, weakness, weight loss and low physical activity. Total score of criteria classifies participants into 3 categories: Not Frail (score 0) Pre-frail (score 1-2) Frail (score 3-5)
次要结局
- Change in Health Education Impact Questionnaire (heiQ) scores(7 months)
- Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L)(7 months)