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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
Scientific title
Wider implementation of the multicomponent frailty management program “Say No To Frailty” for community-living older adults in Singapore
Secondary ID [1] 312390 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 334196 0
Fall 334197 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330855 330855 0 0
Other physical medicine / rehabilitation
Public Health 330858 330858 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328890 0
Prevention
Intervention code [2] 328891 0
Lifestyle
Intervention code [3] 328892 0
Treatment: Other
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
Control group
Active

Outcomes
Primary outcome [1] 338621 0
Frailty
Timepoint [1] 338621 0
Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
Primary outcome [2] 338622 0
Falls
Timepoint [2] 338622 0
Baseline (history of falls in the past 6 months), during three-month intervention and 12 months follow up post-intervention.
Secondary outcome [1] 436674 0
physical functions
Timepoint [1] 436674 0
Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
Secondary outcome [2] 436675 0
Fall-related self-efficacy
Timepoint [2] 436675 0
Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
Secondary outcome [3] 436676 0
the extent of community mobility
Timepoint [3] 436676 0
Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
Secondary outcome [4] 436677 0
the degree of goal achievement
Timepoint [4] 436677 0
Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
Secondary outcome [5] 436678 0
Health-related quality of life
Timepoint [5] 436678 0
Baseline (upon enrollment), immediately post-intervention (3 months from baseline) and 12 months post-intervention (15 months from baseline)
Secondary outcome [6] 436679 0
Participant's Satisfaction
Timepoint [6] 436679 0
3 months post-intervenion
Secondary outcome [7] 436680 0
Cost-effectiveness
Timepoint [7] 436680 0
Monthly during the 12 months follow-up phase
Secondary outcome [8] 436681 0
Compliance rate to exercise prescription
Timepoint [8] 436681 0
Weekly during the 12-week intervention

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.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
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)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 26393 0
Singapore
State/province [1] 26393 0

Funding & Sponsors
Funding source category [1] 316798 0
Government body
Name [1] 316798 0
Ministry of Health, Singapore
Country [1] 316798 0
Singapore
Primary sponsor type
Government body
Name
Ministry of Health, Singapore
Address
Country
Singapore
Secondary sponsor category [1] 319020 0
University
Name [1] 319020 0
Singapore Institute of Technology
Address [1] 319020 0
Country [1] 319020 0
Singapore

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315568 0
Singapore Institute of Technology Institutional Review Board
Ethics committee address [1] 315568 0
[email protected]
Ethics committee country [1] 315568 0
Singapore
Date submitted for ethics approval [1] 315568 0
23/06/2024
Approval date [1] 315568 0
Ethics approval number [1] 315568 0

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.
Trial website
https://occupymytime.wixsite.com/saynotofrailty
Trial related presentations / publications
Public notes
More information will be put up on the website once we secure funding and obtain the ethics approval.

Contacts
Principal investigator
Name 135102 0
Dr Tianma Xu
Address 135102 0
Singapore Institute of Technology, 10 Dover Drive, Singapore 138683
Country 135102 0
Singapore
Phone 135102 0
+6565928673
Fax 135102 0
Email 135102 0
[email protected]
Contact person for public queries
Name 135103 0
Tianma Xu
Address 135103 0
Singapore Institute of Technology, 10 Dover Drive, Singapore 138683
Country 135103 0
Singapore
Phone 135103 0
+6565928673
Fax 135103 0
Email 135103 0
[email protected]
Contact person for scientific queries
Name 135104 0
Tianma Xu
Address 135104 0
Singapore Institute of Technology, 10 Dover Drive, Singapore 138683
Country 135104 0
Singapore
Phone 135104 0
+6565928673
Fax 135104 0
Email 135104 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
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.


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.