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

NCT05371210 | Completed

• 1 other identifier: 2020/01163
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Change in Health Education Impact Questionnaire (heiQ) scores

  4 months

• 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)

  4 months

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

  7 months

Study Arms (2)

SAIF

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants received a one-time health pamphlet after completing baseline assessment. They were followed up at 2-month, 4-month and 7-month thereafter.

Interventions

SAIF OTHER

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

SAIF

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanyang Technological University: collaborator
• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

Location

Related Publications (15)

• 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.

  BACKGROUND

• 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.

  PMID: 26805753 BACKGROUND

• 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.

  PMID: 26715536 BACKGROUND

• 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.

  PMID: 28648901 BACKGROUND

• 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.

  PMID: 21733149 BACKGROUND

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 24908049 BACKGROUND

• 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.

  PMID: 16505261 BACKGROUND

• 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.

  PMID: 28623152 BACKGROUND

• 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.

  PMID: 12806071 BACKGROUND

• 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.

  PMID: 22836700 BACKGROUND

• 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.

  PMID: 28064173 BACKGROUND

• 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.

  PMID: 16129869 BACKGROUND

• 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.

  PMID: 28648903 BACKGROUND

• 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.

  PMID: 23002714 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wee Shiong Lim

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 12, 2022
• Study Start: March 15, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: December 23, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)