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

Sponsor
Tan Tock Seng Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05371210
Collaborator
Nanyang Technological University (Other)
105
1
2
15
7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SAIF
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
SAIF: An End-to-end System for Assessment and Intervention of Frailty
Actual Study Start Date :
Mar 15, 2021
Actual Primary Completion Date :
Jun 16, 2022
Actual Study Completion Date :
Jun 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: SAIF

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

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

  1. Change in frailty scores as measured by Fried Frailty Phenotype (FFP) [4 months]

    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)

  2. Change in frailty scores as measured by Fried Frailty Phenotype (FFP) [7 months]

    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)

  3. Change in physical performance scored based on Short Physical Performance Battery (SPPB) [4 months]

    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. Change in physical performance scored based on Short Physical Performance Battery (SPPB) [7 months]

    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).

  5. Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty [4 months]

    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).

  6. Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty [7 months]

    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

  1. Change in Health Education Impact Questionnaire (heiQ) scores [4 months]

    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.

  2. Change in Health Education Impact Questionnaire (heiQ) scores [7 months]

    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.

  3. Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) [4 months]

    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. Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) [7 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tan Tock Seng Hospital Singapore Singapore 308433

Sponsors and Collaborators

  • Tan Tock Seng Hospital
  • Nanyang Technological University

Investigators

  • Principal Investigator: Wee Shiong Lim, Tan Tock Seng Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT05371210
Other Study ID Numbers:
  • 2020/01163
First Posted:
May 12, 2022
Last Update Posted:
Aug 23, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2022