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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
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frailty

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
May 5, 2022
Last Updated
August 21, 2022
Sponsor
Tan Tock Seng Hospital
Collaborators
Nanyang Technological University
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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
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An End-to-end System for Assessment and Intervention of Frailty

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