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Trial registered on ANZCTR
Registration number
ACTRN12624000908538p
Ethics application status
Submitted, not yet approved
Date submitted
23/06/2024
Date registered
25/07/2024
Date last updated
25/07/2024
Date data sharing statement initially provided
25/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Wider implementation of the frailty management program “Say No To Frailty” in Singapore
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Scientific title
Wider implementation of the multicomponent frailty management program “Say No To Frailty” for community-living older adults in Singapore
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Secondary ID [1]
312390
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Frailty
334196
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Fall
334197
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Condition category
Condition code
Physical Medicine / Rehabilitation
330855
330855
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0
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Other physical medicine / rehabilitation
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Public Health
330858
330858
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Older adult participants will receive the Say No To Frailty program led by a trained healthcare professional, such as physiotherapist, occupational therapist, dietitian, medical social worker, and pharmacist.
The “Say no to frailty” program is a multicomponent group intervention designed for community-living older adults with signs of frailty and pre-frailty. It consists of 12 weekly sessions facilitated by trained program facilitators followed by a booster session and phone calls at 1-month and 3-month post-intervention respectively. The program uses adult learning principles to allow individuals in a small group (n=12) to learn the right exercises and strategies for managing different risk factors at their own pace and be responsible for their health. The aim is to facilitate their behavioural changes through personalized goal setting leading to a healthy lifestyle and age in place.
The duration of each session: 2 hours/session
Main languages used during the intervention: English and/or Mandarin
The following contents will be covered throughout the 12-week intervention:
- Understanding frailty and risk assessment
- Personalised goal setting
- Understanding common chronic health conditions and causes
- Fall prevention strategies
- Healthy lifestyle tips (including healthy eating)
- Strategies for community independent living
- Community mobility practice
- Weekly balance and strength exercises: all exercises are adapted from Otago Exercise Program and ViviFrail.com. The chosen exercises are considered as low intensity, which will be taught by the invited exercise specialist (PT or fitness instructor) in the first two sessions. Example of strength exercises include: arm opening with resistance band, elbow flexion with resistance band, opening arm diagonally with resistance band, reverse knee flexion, heel raises, hip abduction and knee raises. Example of balance exercises include: sit-to-stand, single-leg stand, tandem stand and tandem walk.
The exercises will be upgraded to a moderate level for some individuals who are progressing and checked by the exercise specialist at the later session. Each participant will be reviewed in each weekly session by the trained program facilitator, and whenever participants find the exercises too easy, these exercises will be upgraded (e.g. adding an extra ankle weight or exercise band, increasing the number of repetitions; reducing the base of support) to make it more challenging.
Each participant will be prescribed with weekly homework. For instance, participants are recommended to complete the prescribed strength and balance exercises three times a week using the issued exercise worksheets. Together with other content-related homework (e.g. home safety checklist, daily food diary, community safety hazards, medication log sheet, etc) will be issued to each participant and checked by the program facilitator in the following week. In the event when some participants do not complete the prescribed homework, the program facilitator will find out the barriers and seek inputs from other participants through group discussion.
Session attendance, together with the above weekly homework sheets, will be used to monitor adherence to the intervention.
Materials will be used during the program:
- blood pressure monitor, resistance bands, walking aids, fall prevention probs (e.g. anti-slip solutions, unsafe shoes), healthy eating brochure, fall prevention brochure, weekly program handouts and homework sheets.
The programme also includes a 2-hour booster session one-month post-intervention. In this session, the program facilitator will review the key learning points from the program. The participants will do all balance and strength exercises as part of the review, discuss their coping strategies implemented and any new goal achievements in the past month. Resources and advice will be provided to participants who had challenges in strategy implementation and coping at home.
During the three-month post-intervention follow-up, the program facilitator will make a 10-15 minutes phone call to each participant to find out his/her strategy implementation and any goal achievements in the past two months. All participants will be encouraged to continue reading the program booklet and attending community-based programs (e.g. fitness programs, social programs) to keep them healthy and active.
About the program facilitator:
The Say No To Frailty program will be led by a trained program facilitator who is someone who has a strong interest and a minimum of 1 year of experience working with older adults living in the community. Eligible allied health professionals (e.g. physiotherapists, occupational therapists, social workers, dietitians) or non-allied health professionals (e.g. fitness instructors, exercise trainers, care coordinators, volunteers) working in the participating organizations will complete a 2-day program facilitator training workshop 3 months before starting the Say No To Frailty program. The program facilitator training workshop will be conducted by the PI (Xu) who is a master trainer with more than 20 years of clinical experience in this field. The workshop content includes theoretical frameworks (e.g. adult learning principles), program content, exercise training and facilitation skills through role-play. Each program facilitator will be assessed for competency before being issued with a completion certificate.
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Intervention code [1]
328890
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Prevention
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Intervention code [2]
328891
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Lifestyle
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Intervention code [3]
328892
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Treatment: Other
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Comparator / control treatment
Older adult participants will receive the same intervention - the Say No To Frailty program led by a trained non-healthcare professional, such as fitness instructor, care coordinator, exercise trainer, therapy assistant, volunteer
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Control group
Active
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Outcomes
Primary outcome [1]
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Frailty
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Assessment method [1]
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Clinical Frailty Scale
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Timepoint [1]
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Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
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Primary outcome [2]
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Falls
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Assessment method [2]
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Monthly fall data
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Timepoint [2]
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Baseline (history of falls in the past 6 months), during three-month intervention and 12 months follow up post-intervention.
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Secondary outcome [1]
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physical functions
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Assessment method [1]
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Short Physical Performance Battery
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Timepoint [1]
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Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
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Secondary outcome [2]
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Fall-related self-efficacy
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Assessment method [2]
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Falls Efficacy Scale-International
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Timepoint [2]
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Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
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Secondary outcome [3]
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the extent of community mobility
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Assessment method [3]
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Life-space Assessment
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Timepoint [3]
436676
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Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
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Secondary outcome [4]
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the degree of goal achievement
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Assessment method [4]
436677
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Goal Attainment Scale
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Timepoint [4]
436677
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Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
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Secondary outcome [5]
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Health-related quality of life
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Assessment method [5]
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EuroQol EQ-5D-5L questionnaire
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Timepoint [5]
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Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
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Secondary outcome [6]
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Participant's Satisfaction
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Assessment method [6]
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Program evaluation survey
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Timepoint [6]
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3 months post-intervenion
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Secondary outcome [7]
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Cost-effectiveness
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Assessment method [7]
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All program-related expenditures (e.g. manpower costs, honorarium, purchase of equipment andassessment tools, refreshment and other logistic costs) will be recorded at each participating centreduring the intervention phase to calculate the intervention and manpower costs.
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Timepoint [7]
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Monthly during the 12 months follow-up phase
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Secondary outcome [8]
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Compliance rate to exercise prescription
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Assessment method [8]
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Weekly home exercise sheet will be issued to all older adult participants and checked by the program facilitator weekly.
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Timepoint [8]
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Weekly during the 12-week intervention
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Eligibility
Key inclusion criteria
Inclusion criteria for older adult participants:
- Age 60 years old or above
- Live at home or in the community
- Able to communicate verbally and understand instructions
- Able to walk with/without a walking aid for a short distance independently
- Signs of frailty (e.g. muscle weakness, reduced balance and mobility, loss of weight) with Clinical Frailty Scale (CFS) score between 4 and 6
- No severe cognitive impairment (Abbreviated Mental Test score >5)*
*Clients with mild cognitive impairment is eligible to join this program; however, he/she must be accompanied by a caregiver during the group sessions.
Inclusion criteria for program facilitators
- Any care staff or volunteers who received a 2-day program facilitator training and facilitated at least one group of older adults during the study period.
Inclusion criteria for centre staff:
- Any centre staff from the participating centres who supported the SNTF program during the study period.
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria for older adult participants:
- Absence of frailty or pre-frailty
- Diagnosed with dementia or AMT scores 5 or lower.
- Inability to walk independently without the help of another person or wheelchair-bound
- Recent cardiac arrest or any unstable medical conditions
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Sample size
The recommended group size per program at each centre is 10. We aim to reach out to at least 30 community-based centres that provide outpatient services and programs to community-living older adults. Hence, the target sample size from all 30 participating centres will be 300.
Quantitative data statistical analysis
Descriptive statistics will be used to present the baseline characteristics of each group. While we will attempt to minimize attrition, there will be missing data at the repeated assessments due to potential dropouts or participant unavailability. All analyses will be performed according to the intention-to-treat principle and include all participants who underwent preintervention assessment. the multiple imputation method will be used to impute the missing data to avoid creating false precision (Li et al., 2015). Comparisons across groups at baseline will be performed by independent t-test for continuous variables and Fisher’s exact test for categorical variables. Mixed analysis of variance (ANOVA) will be used to determine if there were any statistically significant between-group effects, within-group effects, and group-time interactions, in which clustering will be included as a random effect. Tukey’s post hoc test will be carried out if a statistically significant group-time interaction is observed. Statistical significance will be set at p < 0.05 for all comparisons. Besides the p-value, effect size (partial eta squared, ?p2) will be also calculated to determine the magnitude of the intervention effects observed, where 0.01 is a small effect, 0.06 is a medium effect, and 0.14 is a large effect. All data analyses will be conducted using statistical analysis software (e.g. SPSS, STATA).
The exercise compliance rate will be calculated based on the number of days each participant did the exercises using the given homework sheets or via the communication app. A minimum of 3 times strengthen and balance exercises will be considered 100% compliance as suggested in other evidence-based programs for older adults (Campbell & Robertson, 2003; Clemson et al., 2004) and an international guideline (Izquierdo et al., 2021).
The proportions of people in different groups who had one or more falls during the 12 months of follow-up (cumulative incidence ratios) will be compared. Falls outcomes will also be analysed at 2 different time points: from commencement to the end of the 3-month post-intervention follow-up, and from commencement to the end of the 12-month post-intervention follow-up.
Qualitative data analysis
The FGDs will be transcribed verbatim and thematically analysed to understand the general comments and feedback on the program's quality and delivery. The line-by-line coding method will be used with guidance from Braun and Clarke's (2006) process to identify and analyse trends in the qualitative data set.
Cost-effectiveness analysis
Economic evaluation, specifically cost-effectiveness analysis (also known as cost-utility analysis) will be used as a form of assessment for this project. Cost-effective analysis, the most widely published form of economic evaluation, is a tool for facilitating a systematic, consistent and transparent decision-making process for efficient healthcare resource allocation (Drummond et al., 2015). Incremental cost-effectiveness analyses focus on the incremental cost per unit of benefit (which is Quality-Adjusted Life Years or QALYs)
Incremental Cost-Effectiveness Ratio or ICER (cost per QALY):
(Intervention costs – Non-intervention costs)/(Intervention QALY – Non-intervention QALY)
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26393
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Singapore
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State/province [1]
26393
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Funding & Sponsors
Funding source category [1]
316798
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Government body
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Name [1]
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Ministry of Health, Singapore
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Address [1]
316798
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Country [1]
316798
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Singapore
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Primary sponsor type
Government body
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Name
Ministry of Health, Singapore
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Address
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Country
Singapore
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Secondary sponsor category [1]
319020
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University
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Name [1]
319020
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Singapore Institute of Technology
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Address [1]
319020
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Country [1]
319020
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Singapore
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Singapore Institute of Technology Institutional Review Board
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Ethics committee address [1]
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irb@singaporetech.edu.sg
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Ethics committee country [1]
315568
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Singapore
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Date submitted for ethics approval [1]
315568
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23/06/2024
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Approval date [1]
315568
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Ethics approval number [1]
315568
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Summary
Brief summary
The 12-week multicomponent frailty management program – Say No to Frailty (SNTF) led by a trained program facilitator in a small group setting (n=10-12) has demonstrated feasibility (2019). The current cluster-randomised clinical trial (c-RCT) (since 2022) has produced promising preliminary findings on program effectiveness and implementation process. This research will focus on strengthening fidelity and expansion and scaling the SNTF program at 30 community sites locally. All participating centres will be randomly allocated to two different intervention packages (Package A: Healtghcare professional [HCP]-led; Package B: non-HCP-led) with pre-post assessments at 3 different time points. We aim to validate whether the positive health outcomes (e.g. physical functions, self-efficacy, lifestyle changes, community participation and quality of life) from the previous studies can be maintained. We also plan to validate its cost-effectiveness, one-year long-term effect, and effect difference between programs led by a trained HCP and a trained non-HCP.
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Trial website
https://occupymytime.wixsite.com/saynotofrailty
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Trial related presentations / publications
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Public notes
More information will be put up on the website once we secure funding and obtain the ethics approval.
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Contacts
Principal investigator
Name
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Dr Tianma Xu
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Address
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Singapore Institute of Technology, 10 Dover Drive, Singapore 138683
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Country
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Singapore
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Phone
135102
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+6565928673
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Tianma Xu
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Address
135103
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Singapore Institute of Technology, 10 Dover Drive, Singapore 138683
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Country
135103
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Singapore
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Phone
135103
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+6565928673
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Fax
135103
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Email
135103
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[email protected]
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Contact person for scientific queries
Name
135104
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Tianma Xu
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Address
135104
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Singapore Institute of Technology, 10 Dover Drive, Singapore 138683
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Country
135104
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Singapore
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Phone
135104
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+6565928673
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Fax
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Email
135104
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
All individual participant data (IPD) for this trial will not be available for sharing. All collected data will be stored at PI's university research depository office as part of the organization's policy.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF