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

Frailty Clinical Trial

— SAIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05371210
• Other study ID #: 2020/01163
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: June 16, 2022

Study information

• Verified date: August 2022
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age 60 and above

2. CFS 4 or 5 / CFS 3 with FRAIL score at least 1 / CFS 3 with FPQ score at least 1

3. Ambulate for at least 10m without walking aid

4. English and/or Mandarin speaking

Exclusion Criteria:

1. Known diagnosis of dementia or CMMSE score <19

2. Parkinson's disease

3. Hip surgery within the last 6 months

4. Presence of end-stage organ failure, symptomatic heart conditions or COPD

5. Active arthritis

6. Hospitalisation within the last 1 month

7. Participants who are unable to provide consent

Related Conditions & MeSH terms

• Frailty

Intervention

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

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

References & 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.

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. — View Citation

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. — View Citation

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-Mañas 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. Erratum in: J Am Med Dir Assoc. 2018 Jan;19(1):94. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mitnitski AB, Mogilner AJ, Rockwood K. Accumulation of deficits as a proxy measure of aging. ScientificWorldJournal. 2001 Aug 8;1:323-36. — View Citation

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. — View Citation

Puts MTE, Toubasi S, Andrew MK, Ashe MC, Ploeg J, Atkinson E, Ayala AP, Roy A, Rodríguez 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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