An End-to-end System for Assessment and Intervention of Frailty (SAIF)
Primary Purpose
Frailty
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
SAIF
Sponsored by
About this trial
This is an interventional other trial for Frailty
Eligibility Criteria
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
Sites / Locations
- Tan Tock Seng Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SAIF
Control
Arm Description
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).
Participants received a one-time health pamphlet after completing baseline assessment. They were followed up at 2-month, 4-month and 7-month thereafter.
Outcomes
Primary Outcome Measures
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)
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)
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).
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).
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).
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).
Secondary Outcome Measures
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.
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.
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).
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).
Full Information
NCT ID
NCT05371210
First Posted
May 5, 2022
Last Updated
August 21, 2022
Sponsor
Tan Tock Seng Hospital
Collaborators
Nanyang Technological University
1. Study Identification
Unique Protocol Identification Number
NCT05371210
Brief Title
An End-to-end System for Assessment and Intervention of Frailty
Acronym
SAIF
Official Title
SAIF: An End-to-end System for Assessment and Intervention of Frailty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
June 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Nanyang Technological University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAIF
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants received a one-time health pamphlet after completing baseline assessment. They were followed up at 2-month, 4-month and 7-month thereafter.
Intervention Type
Other
Intervention Name(s)
SAIF
Intervention Description
Participants interacted with SAIF system at least 2-3 times per week; each session took up to 20 minutes.
Primary Outcome Measure Information:
Title
Change in frailty scores as measured by Fried Frailty Phenotype (FFP)
Description
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)
Time Frame
4 months
Title
Change in frailty scores as measured by Fried Frailty Phenotype (FFP)
Description
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)
Time Frame
7 months
Title
Change in physical performance scored based on Short Physical Performance Battery (SPPB)
Description
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).
Time Frame
4 months
Title
Change in physical performance scored based on Short Physical Performance Battery (SPPB)
Description
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).
Time Frame
7 months
Title
Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty
Description
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).
Time Frame
4 months
Title
Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty
Description
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).
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Change in Health Education Impact Questionnaire (heiQ) scores
Description
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.
Time Frame
4 months
Title
Change in Health Education Impact Questionnaire (heiQ) scores
Description
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.
Time Frame
7 months
Title
Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L)
Description
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).
Time Frame
4 months
Title
Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L)
Description
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).
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wee Shiong Lim
Organizational Affiliation
Tan Tock Seng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
26805753
Citation
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.
Results Reference
background
PubMed Identifier
26715536
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.
Results Reference
background
PubMed Identifier
28648901
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-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. Erratum In: J Am Med Dir Assoc. 2018 Jan;19(1):94.
Results Reference
background
PubMed Identifier
21733149
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.
Results Reference
background
PubMed Identifier
11253156
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. doi: 10.1093/gerona/56.3.m146.
Results Reference
background
PubMed Identifier
24908049
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.
Results Reference
background
PubMed Identifier
16505261
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. doi: 10.1001/archinte.166.4.418.
Results Reference
background
PubMed Identifier
28623152
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.
Results Reference
background
PubMed Identifier
12806071
Citation
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.
Results Reference
background
PubMed Identifier
22836700
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. doi: 10.1007/s12603-012-0084-2.
Results Reference
background
PubMed Identifier
28064173
Citation
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.
Results Reference
background
PubMed Identifier
16129869
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. doi: 10.1503/cmaj.050051.
Results Reference
background
PubMed Identifier
28648903
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.
Results Reference
background
PubMed Identifier
23002714
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.
Results Reference
background
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An End-to-end System for Assessment and Intervention of Frailty
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