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Completed

NCT Number: NCT05371210

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

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore, 308433

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAIF

Other

Participants interacted with SAIF system at least 2-3 times per week; each session took up to 20 minutes.

Primary outcomes

  1. Change in frailty scores as measured by Fried Frailty Phenotype (FFP)

    Time frame: 4 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)

  2. Change in frailty scores as measured by Fried Frailty Phenotype (FFP)

    Time frame: 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)

  3. Change in physical performance scored based on Short Physical Performance Battery (SPPB)

    Time frame: 4 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).

  4. Change in physical performance scored based on Short Physical Performance Battery (SPPB)

    Time frame: 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).

  5. Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty

    Time frame: 4 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).

  6. Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty

    Time frame: 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).

Secondary outcomes

  1. Change in Health Education Impact Questionnaire (heiQ) scores

    Time frame: 4 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.

  2. Change in Health Education Impact Questionnaire (heiQ) scores

    Time frame: 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.

  3. Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L)

    Time frame: 4 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).

  4. Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • Nanyang Technological University

Registry information

Official study title

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

Acronym: SAIF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 12, 2022
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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