Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001673831
Ethics application status
Approved
Date submitted
31/05/2021
Date registered
7/12/2021
Date last updated
1/05/2024
Date data sharing statement initially provided
7/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing the effectiveness of a multicomponent frailty management program in Singapore
Scientific title
Clinical effectiveness and cost-effectiveness of a multicomponent frailty management program “Say No To Frailty” in Singapore for adults over 65: A Cluster-randomized controlled trial
Secondary ID [1] 304360 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 322145 0
Falls 322146 0
Condition category
Condition code
Physical Medicine / Rehabilitation 319838 319838 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be a three-arm cluster-randomised trial to evaluate the cost-effectiveness of the multi-component frailty management program over 12 months. Each participating centre will be randomly assigned to intervention A, B or C using a computer-generated list. Centres with intervention A will conduct the frailty management program led by an Allied Health Professional (AHP). Centres with intervention B will conduct the Frailty management program led by a non-AHP. Centres with intervention C will carry on with usual care without additional intervention.

The programme (intervention A &B) consists of 12 weekly group sessions facilitated by a trained program leader (AHP or non-AHP). This is followed by a one-month booster session and a 3-month phone call as part of the follow-up.

Group size: 10-12 participants
The mode of delivery: It is a group-based intervention. Upon program commencement, the program leader facilitates each participant in a small group setting (group size 10-12) to set personal goals that will be reviewed after the completion of the 12-week intervention. The weekly sessions involve a 1-hour talk by healthcare professionals like dietitians, occupational therapists, physiotherapists (or exercise trainers), and pharmacists, covering different topics such as frailty and risk assessment, common chronic health conditions, fall prevention strategies, healthy lifestyle tips (including healthy diet), strategies for community independent living and safe community mobility practice. Next is a 15-minute break to encourage social networking between participants, followed by 45 minutes of low-to-moderate intensity balance and strength exercises. At the beginning of each session, the program leader checks the weekly homework consisting of strength and balance exercises and different content topics. Throughout the 3-month intervention, the program leader calls absent participants to update them on the missed content.

Balance and strength exercises are adapted from Otago Exercise Program and ViviFrail.com. The chosen exercises (e.g.e.g. arm strengthening exercises with theraband, leg and calf raises, reverse knee bend, side hip strengthening, partial squat, sit-to-stand, single leg stand, tandem walking) are considered as low intensity, which will be upgraded to a moderate level for some individuals who are progressing. Exercises will be checked by the exercise specialist (PT or fitness instructor) at the later session

Materials used during the program:
- blood pressure monitor, therabands, walking aids, fall prevention probs (e.g. anti-slip solutions, unsafe shoes),
- healthy eating brochure (https://www.healthhub.sg/sites/assets/Assets/Programs/my-healthy-plate/pdfs/My_Healthy_Plate_Fact_Sheet_-_Updated_4May_2021.pdf)
- fall prevention brochure (https://www.healthhub.sg/sites/assets/Assets/PDFs/HPB/Falls%20Prevention/Falls%20Prevention%20Guidebook_English.pdf)
- weekly program handouts and homework sheets.
Strategies used to assess or monitor participants’ compliance to the intervention:
- Weekly homework will be checked by the program facilitator;
- Weekly attendance will be recorded.

The programme also includes a 2-hour booster session at one-month post-intervention. In this session, the program facilitator will review the key learning points from the program. They will do all strength and balance exercises as part of the review, and 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 follow-up, the program facilitator will make a 10-15-minute 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 program leaders
The Say No To Frailty program is led/facilitated by a trained program leader. The program leader is someone who has a strong interest and a minimum of 2 years of experience working with older adults living in the community. Any allied health professionals (e.g. physiotherapists, occupational therapists, social workers, nurses, dietitians) or non-allied health professionals (e.g. fitness instructors, exercise trainers, care coordinators) must complete a 3-day program leader training workshop as pre-requisition before starting the Say No To Frailty program.
Intervention code [1] 320720 0
Lifestyle
Intervention code [2] 320721 0
Prevention
Intervention code [3] 320722 0
Behaviour
Comparator / control treatment
Usual care (Intervention C) includes common activities, such as functional assessment, gym exercises, social activities, outings, games, arts and crafts, singing, etc. No changes will be imposed on the participants by the participating centres and the researchers.
Control group
Active

Outcomes
Primary outcome [1] 327709 0
Clinical Frailty Scale will be used as the primary outcome measure to assess the frailty status.
Timepoint [1] 327709 0
This will be conducted at the baseline, immediate post-intervention (primary endpoint), 3-month and 9-month post-intervention.
Secondary outcome [1] 396287 0
A hand dynamometer will be used to assess handgrip strength;
Timepoint [1] 396287 0
It will be conducted at the baseline, immediate post-intervention, 3-month and 9-month post-intervention.
Secondary outcome [2] 396288 0
The Short Physical Performance Battery (SPPB) will be used to evaluate the changes in physical functions;
Timepoint [2] 396288 0
It will be conducted at the baseline, immediate post-intervention, 3-month and 9-month post-intervention.
Secondary outcome [3] 396289 0
The Falls-Efficacy Scale - International (FES- I) will be used to assess the level of self-efficacy or fear of falling in performing self-care activities.
Timepoint [3] 396289 0
It will be conducted at the baseline, immediate post-intervention, 3-month and 9-month post-intervention.
Secondary outcome [4] 396290 0
The Life-space Assessment (LSA) will be used to assess the extent of mobility and the level of community participation among community stroke survivors.
Timepoint [4] 396290 0
It will be conducted at the baseline, immediate post-intervention, 3-month and 9-month post-intervention.
Secondary outcome [5] 396291 0
The Goal Attainment Scale (GAS) will be used to evaluate the degree of goal achievements.
Timepoint [5] 396291 0
It will be conducted at the baseline, immediate post-intervention, 3-month and 9-month post-intervention.
Secondary outcome [6] 396292 0
The EQ-5D-5L will be used to detect any changes in self-perceived quality of life.
Timepoint [6] 396292 0
It will be conducted at the baseline, immediate post-intervention, 3-month and 9-month post-intervention.
Secondary outcome [7] 396293 0
The number of falls per participant will be recorded using the monthly fall calendar that will be issued to each participant. A monthly phone call will be made to remind each participant to fill up the monthly fall calendar.
Timepoint [7] 396293 0
Any fall incidents will be recorded from baseline to 9 months post-intervention.
Secondary outcome [8] 396294 0
Daily step counts will be recorded by individual participants using the given diary.
Timepoint [8] 396294 0
It will be done during the 12-week intervention phase.
Secondary outcome [9] 401564 0
Cost-effectiveness:
All program-related expenditures (e.g. manpower costs, honorarium, purchase of equipment and assessment tools, refreshment and other logistic costs) will be recorded at each participating centre during the intervention phase to calculate the intervention and manpower costs.
Cost-effectiveness analyses will be in terms of the incremental cost per participant with averted health care treatment costs (e.g. hospitalization and pharmaceutical expenses) resulting from existing chronic health conditions or fall-related incidents during the 9-month follow-up phase. The incremental cost per Quality-Adjusted Life Years (QALYs) gained over 9 months will be also analysed in conjunction with the responses from the EQ-5D-5L. A prespecified subgroup analysis will be conducted to examine the cost-effectiveness of the intervention stratified by level of frailty at baseline: vulnerable (CFS:4), mildly frail (CFS:5) or moderately frail (CFS:6).
Timepoint [9] 401564 0
during the 9 months follow-up phase

Eligibility
Key inclusion criteria
Inclusion criteria:
- Age 65 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) scored 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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
- 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features

Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size
Based on the attrition rate of 25% in our previous pilot (Xu, Yeh, Ng, Wong, & Koh, 2020), a total of 120 participants will be needed to achieve 80% power with a confidence interval set at 0.05 to detect the mean change of Clinical Frailty Scale of 1 score with a medium effect size of 0.3.

Data analysis
Baseline characteristics will be analyzed using descriptive statistics and compared among the three groups (A, B and C). The chi-square test will be used to determine the significance of differences for categorical variables, and the analysis of variance (ANOVA) F-test will be used for continuous variables between groups. Multiple pairwise comparisons with a Tukey adjustment will be examined to see if the changes from pre- to post-intervention or from pre-intervention to follow-up are significantly different from baseline within each group.

A generalized linear mixed model will be used to analyze changes in outcome measures as functions of the intervention group, time, and Group × Time interaction. Cohen’s d effect sizes were calculated from mean changes derived from the generalized linear mixed model. Cox proportional hazards model method will be used to analyze the time to one or more (injurious) falls among participants who experience one or more falls during the 12-month follow-up. Multivariate analysis will be conducted to find out the potential independent variables leading to a higher risk of falling. P values less than .05 will be considered statistically significant.

The cost-effectiveness analyses will be conducted in this project. The analyses focus on the incremental cost per unit of benefit (which is Quality-Adjusted Life Years or QALYs) gained for participants who receive a multicomponent frailty management program (Intervention) in comparison with participants who receive usual care (comparator) for the duration of 12 months (12-week multicomponent frailty management program and the 9-month follow-up phase).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
15/06/2022
Date of last participant enrolment
Anticipated
29/03/2024
Actual
15/03/2024
Date of last data collection
Anticipated
27/03/2025
Actual
Sample size
Target
120
Accrual to date
Final
116
Recruitment outside Australia
Country [1] 23740 0
Singapore
State/province [1] 23740 0
Singapore

Funding & Sponsors
Funding source category [1] 308729 0
University
Name [1] 308729 0
Singapore Institute of Technology
Country [1] 308729 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Drive, Singapore 138683
Country
Singapore
Secondary sponsor category [1] 311437 0
None
Name [1] 311437 0
Address [1] 311437 0
Country [1] 311437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308649 0
The Institutional Review Board of Singapore Institute of Technology
Ethics committee address [1] 308649 0
Ethics committee country [1] 308649 0
Singapore
Date submitted for ethics approval [1] 308649 0
31/12/2021
Approval date [1] 308649 0
24/02/2022
Ethics approval number [1] 308649 0
2022006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111430 0
Dr Tianma Xu
Address 111430 0
Health and Social Sciences Cluster,
Singapore Institute of Technology,
10 Dover Drive, Singapore 138683
Country 111430 0
Singapore
Phone 111430 0
+6565928673
Fax 111430 0
Email 111430 0
[email protected]
Contact person for public queries
Name 111431 0
Tianma Xu
Address 111431 0
Health and Social Sciences Cluster,
Singapore Institute of Technology,
10 Dover Drive, Singapore 138683
Country 111431 0
Singapore
Phone 111431 0
+6565928673
Fax 111431 0
Email 111431 0
[email protected]
Contact person for scientific queries
Name 111432 0
Tianma Xu
Address 111432 0
Health and Social Sciences Cluster,
Singapore Institute of Technology,
10 Dover Drive, Singapore 138683
Country 111432 0
Singapore
Phone 111432 0
+6565928673
Fax 111432 0
Email 111432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the organizational data management policy and data protection laws under the PDPA act in Singapore, we will not be able to share any individual participant data from this trial with the public.


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.