An End-to-end System for Assessment and Intervention of Frailty
- Conditions
- Frailty
- Interventions
- Other: SAIF
- Registration Number
- NCT05371210
- Lead Sponsor
- Tan Tock Seng Hospital
- Brief Summary
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.
- Detailed Description
SAIF is a personalised, community-based system for both assessment and intervention of frailty. It comprises of 8 modules categorised into
1. Interface: virtual nurse and caregiver gateway
2. 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
3. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAIF SAIF After completion of baseline assessment, participants were required to interact with the SAIF system for 4 months. They were followed up at 2-month (mid-way of intervention), 4-month (end of intervention), and 7-month (3 months post-intervention).
- Primary Outcome Measures
Name Time Method Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty 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) 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) 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)
- Secondary Outcome Measures
Name Time Method Change in Health Education Impact Questionnaire (heiQ) scores 7 months heiQ is a validated, self-reported instrument with 8 domains to comprehensively evaluate patient education program and self-management intervention. Each domain score ranges from 1 to 4; a higher score indicates better outcome.
Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) 7 months EQ-5D-5L is a validated, self-reported questionnaire that comprises 5 descriptive domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and self-rated health scale (0 being the worst health imagine and 100 being the best health imagine).
Trial Locations
- Locations (1)
Tan Tock Seng Hospital
šøš¬Singapore, Singapore