Clinical trial NCT05371210: An End-to-end System for Assessment and Intervention of Frailty
Official title: SAIF: An End-to-end System for Assessment and Intervention of Frailty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Nanyang Technological University
First posted: 2022-05-12
Enrollment: 105
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in frailty scores as measured by Fried Frailty Phenotype (FFP)
timeFrame: 4 months
measure: Change in frailty scores as measured by Fried Frailty Phenotype (FFP)
timeFrame: 7 months
measure: Change in physical performance scored based on Short Physical Performance Battery (SPPB)
timeFrame: 4 months
measure: Change in physical performance scored based on Short Physical Performance Battery (SPPB)
timeFrame: 7 months
measure: Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty
timeFrame: 4 months
measure: Correlation between SAIF system and Clinical Frailty Scale (CFS) for identification of pre-frailty and frailty
timeFrame: 7 months
Secondary outcomes:
measure: Change in Health Education Impact Questionnaire (heiQ) scores
timeFrame: 4 months
measure: Change in Health Education Impact Questionnaire (heiQ) scores
timeFrame: 7 months
measure: Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L)
timeFrame: 4 months
measure: Change in quality of life as measured by five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L)
timeFrame: 7 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Wee Shiong Lim
role: PRINCIPAL_INVESTIGATOR
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