An End-to-end System for Assessment and Intervention of Frailty

Study Overview
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Brief Summary
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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
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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.

Official Title
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SAIF: An End-to-end System for Assessment and Intervention of Frailty

Conditions
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Frailty

Intervention / Treatment
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* Other: SAIF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAIF<br>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). | Other: SAIF<br>* Participants interacted with SAIF system at least 2-3 times per week; each session took up to 20 minutes.<br>|
| No Intervention: Control<br>Participants received a one-time health pamphlet after completing baseline assessment. They were followed up at 2-month, 4-month and 7-month thereafter. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frailty scores as measured by Fried Frailty Phenotype (FFP) | 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) | 4 months | 
| Change in frailty scores as measured by Fried Frailty Phenotype (FFP) | 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) | 7 months | 
| Change in physical performance scored based on Short Physical Performance Battery (SPPB) | 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). | 4 months | 
| Change in physical performance scored based on Short Physical Performance Battery (SPPB) | 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). | 7 months | 
| Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty | 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). | 4 months | 
| Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty | 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). | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Education Impact Questionnaire (heiQ) scores | 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. | 4 months | 
| Change in Health Education Impact Questionnaire (heiQ) scores | 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. | 7 months | 
| Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) | 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). | 4 months | 
| Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) | 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). | 7 months |