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FrailtySAIFNCT05371210

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

A study testing SAIF in people with Frailty, run by Tan Tock Seng Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 90 years
Conditions the study is for
Frailty
What is being tested?
SAIF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteSingapore
Study dates
15 Mar 2021to 16 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • Tan Tock Seng Hospital

    Singapore, Singapore, 308433

Other trials in Singapore

About this study

Official title: SAIF: 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.

Read the 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.

Conditions
Frailty
Being tested
SAIF
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAIFOther

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

Study groups in NCT05371210
Study groupRoleWhat they receive
SAIFExperimentalAfter 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).
Receives: Other: SAIF
ControlNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 4 months

  2. 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)

    Measured: 7 months

  3. 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).

    Measured: 4 months

  4. 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).

    Measured: 7 months

  5. 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).

    Measured: 4 months

  6. 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).

    Measured: 7 months

Secondary outcomes (4)
  1. 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.

    Measured: 4 months

  2. 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.

    Measured: 7 months

  3. 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).

    Measured: 4 months

  4. 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).

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2022
  2. Study start15 Mar 2021
  3. Primary completion16 Jun 2022
  4. Study completion16 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05371210
Sponsor's protocol ID
2020/01163
Acronym
SAIF
Status last verified
Aug 2022
First submitted
5 May 2022
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Borrat-Besson, C., Ryser, V.-A., amp; Wernli, B. (2013). Transition between frailty states - A European comparison. In A. Börsch-Supan, M. Brandt, H. Litwin, G. Weber (Eds.), Active ageing and solidarity between generations in Europe - First results from SHARE after the economic crisis, 175-186.

  • Cesari M, Prince M, Thiyagarajan JA, De Carvalho IA, Bernabei R, Chan P, Gutierrez-Robledo LM, Michel JP, Morley JE, Ong P, Rodriguez Manas L, Sinclair A, Won CW, Beard J, Vellas B. Frailty: An Emerging Public Health Priority. J Am Med Dir Assoc. 2016 Mar 1;17(3):188-92. doi: 10.1016/j.jamda.2015.12.016. Epub 2016 Jan 21.

    PubMed 26805753
  • Chong MS, Tay L, Chan M, Lim WS, Ye R, Tan EK, Ding YY. Prospective longitudinal study of frailty transitions in a community-dwelling cohort of older adults with cognitive impairment. BMC Geriatr. 2015 Dec 29;15:175. doi: 10.1186/s12877-015-0174-1.

    PubMed 26715536
  • Dent E, Lien C, Lim WS, Wong WC, Wong CH, Ng TP, Woo J, Dong B, de la Vega S, Hua Poi PJ, Kamaruzzaman SBB, Won C, Chen LK, Rockwood K, Arai H, Rodriguez-Manas L, Cao L, Cesari M, Chan P, Leung E, Landi F, Fried LP, Morley JE, Vellas B, Flicker L. The Asia-Pacific Clinical Practice Guidelines for the Management of Frailty. J Am Med Dir Assoc. 2017 Jul 1;18(7):564-575. doi: 10.1016/j.jamda.2017.04.018.

    PubMed 28648901
  • Fairhall N, Langron C, Sherrington C, Lord SR, Kurrle SE, Lockwood K, Monaghan N, Aggar C, Gill L, Cameron ID. Treating frailty--a practical guide. BMC Med. 2011 Jul 6;9:83. doi: 10.1186/1741-7015-9-83.

    PubMed 21733149
  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156
  • Geraedts HA, Zijlstra W, Zhang W, Bulstra S, Stevens M. Adherence to and effectiveness of an individually tailored home-based exercise program for frail older adults, driven by mobility monitoring: design of a prospective cohort study. BMC Public Health. 2014 Jun 7;14:570. doi: 10.1186/1471-2458-14-570.

    PubMed 24908049
  • Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23. doi: 10.1001/archinte.166.4.418.

    PubMed 16505261
  • Merchant RA, Chen MZ, Tan LWL, Lim MY, Ho HK, van Dam RM. Singapore Healthy Older People Everyday (HOPE) Study: Prevalence of Frailty and Associated Factors in Older Adults. J Am Med Dir Assoc. 2017 Aug 1;18(8):734.e9-734.e14. doi: 10.1016/j.jamda.2017.04.020. Epub 2017 Jun 13.

    PubMed 28623152
  • Mitnitski AB, Mogilner AJ, Rockwood K. Accumulation of deficits as a proxy measure of aging. ScientificWorldJournal. 2001 Aug 8;1:323-36. doi: 10.1100/tsw.2001.58.

    PubMed 12806071
  • Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2.

    PubMed 22836700
  • Puts MTE, Toubasi S, Andrew MK, Ashe MC, Ploeg J, Atkinson E, Ayala AP, Roy A, Rodriguez Monforte M, Bergman H, McGilton K. Interventions to prevent or reduce the level of frailty in community-dwelling older adults: a scoping review of the literature and international policies. Age Ageing. 2017 May 1;46(3):383-392. doi: 10.1093/ageing/afw247.

    PubMed 28064173
  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PubMed 16129869
  • Teo N, Gao Q, Nyunt MSZ, Wee SL, Ng TP. Social Frailty and Functional Disability: Findings From the Singapore Longitudinal Ageing Studies. J Am Med Dir Assoc. 2017 Jul 1;18(7):637.e13-637.e19. doi: 10.1016/j.jamda.2017.04.015.

    PubMed 28648903
  • Verghese J, Holtzer R, Lipton RB, Wang C. Mobility stress test approach to predicting frailty, disability, and mortality in high-functioning older adults. J Am Geriatr Soc. 2012 Oct;60(10):1901-5. doi: 10.1111/j.1532-5415.2012.04145.x. Epub 2012 Sep 24.

    PubMed 23002714

Questions about this trial

What is this clinical trial studying?

A study testing SAIF in people with Frailty, run by Tan Tock Seng Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in frailty scores as measured by Fried Frailty Phenotype (FFP) (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05371210, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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