Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000693527
Ethics application status
Approved
Date submitted
9/11/2023
Date registered
31/05/2024
Date last updated
31/05/2024
Date data sharing statement initially provided
31/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The FITTEST Study: Supporting older people to participate in frailty prevention programs
Scientific title
FITTEST Study: Evaluating the impact of multi-component interventions on frailty in mildly frail older adults in Australia – a randomised type 1 comparative effectiveness-implementation study
Secondary ID [1] 310777 0
AFN21-01
Universal Trial Number (UTN)
Trial acronym
FITTEST Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 331741 0
Condition category
Condition code
Public Health 328491 328491 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6-month supervised: health professional-directed frailty program encompassing exercise, nutrition, medication optimisation and social connectedness, with telephone health coach support (to set goals with participants, tailor behaviour-change strategies, review progress and motivate participation, plus web-based frailty information and resources to support self-management,

Participants in this group will receive:
- A personalised telehealth dietetics appointment to develop a unique nutrition plan - 1 appointment at program initiation, delivered by a registered dietitian lasting up to 60 minutes. Adherence will be monitored and supported by a health coach
- Twice-weekly in-person progressive resistance training with a qualified exercise professional (exercise physiologist or physiotherapist with relevant training provided by our team). The exercise intervention will be delivered one-on-one with intensity and weight determined for each participant individually (example exercises: squats, tricep dips, plantar flexion). Sessions will last approximately 30 minutes, with balance training prescribed at home (4 days per week, 30 minutes).
- Health coaching to remain on track with all four pillars (exercise, nutrition, medication optimisation and social engagement. Participants will be entitled to up to 11 health coaching calls over the 6 months, starting at 4x weekly, then 4x fortnightly, then 3x monthly. Each session will last up to 60 minutes. Health coaches will have an allied health background and prior health coaching training and experience. Additional training will be provided, if needed, by our health coach coordinator.
- Medication optimisation will occur through a purpose-built website where participants will complete activities to uncover their goals of care (related to their medications), make a list of the medications they are currently taking, and be instructed to visit their GP to help align their medications with their goals. Participants only need to do this once, at the beginning of their program, and it will take approx. 30 - 60 mins. Adherence will be supported by the health coach.
- Social engagement will consist of three components (1) inviting a 'buddy' to participate in components of the program will them, (2) attending group-based health coaching sessions, once per month, will other intervention group participants, delivered online, and (3) having access to a range of community activities and events to increase their social connectivity. These activities will be displayed on our fittest website and available for everyone to view. There is no minimum engagement for this component as it is determined by the needs of the participants and will be supported by the health coach during regular sessions.

Our web-based frailty information is derived from the Asia Pacific Clinical Frailty Guidelines, but all materials have been specifically created for this study. Adherence to the intervention will be assessed by investigating the proportion of dietetics appointments attended, the proportion of exercise sessions attended, and the number of health coaching calls conducted.
Intervention code [1] 327182 0
Behaviour
Intervention code [2] 327183 0
Lifestyle
Comparator / control treatment
A 6-month self-directed program with web-based frailty information and resources to support self-management.

The online content will provide a comprehensive overview of:
- Exercise: background of importance of weight bearing training on frailty, comprehensive overview of all exercises to be performed with factsheets and instructional videos.
- Nutrition: background of importance of protein and vitamin D on frailty, a nutrition self-assessment and targeted dietary changes
- Medications: background of importance of medication optimisation on frailty, goals-based assessment linking medications with goals, and instructions to discuss medications with GP
Social engagement: background on importance of social engagement on frailty and other health behaviours, importance of having a support person in this trial, and links to community programs that can assist with engagement.

Content will be presented mostly statically and through videos (exercise content). While there is no minimum engagement required from participants, meeting all our recommendations would mean they are engaging in the program for approximately 30 minutes per day. Participants will be provided with a target exercise schedule to meet, and engagement with the website will be monitored through web-portal analytics.
Control group
Active

Outcomes
Primary outcome [1] 336309 0
Frailty index
Timepoint [1] 336309 0
Six months after randomisation
Secondary outcome [1] 427801 0
Frailty index
Timepoint [1] 427801 0
Twelve months after randomisation
Secondary outcome [2] 427802 0
Quality of life
Timepoint [2] 427802 0
Six and twelve months after randomisation
Secondary outcome [3] 427803 0
VR-12 physical component summary score (0-100)
Timepoint [3] 427803 0
Six and twelve months after randomisation
Secondary outcome [4] 427804 0
VR-12 mental component summary score
Timepoint [4] 427804 0
Six and twelve months after randomisation
Secondary outcome [5] 427805 0
Physical performance
Timepoint [5] 427805 0
Six and twelve months after randomisation
Secondary outcome [6] 427806 0
Weekly physical activity
Timepoint [6] 427806 0
Six and twelve months after randomisation
Secondary outcome [7] 427807 0
Energy expenditure, kcal/minute
Timepoint [7] 427807 0
Six and twelve months after randomisation
Secondary outcome [8] 427808 0
Nutritional status
Timepoint [8] 427808 0
Six and twelve months after randomisation
Secondary outcome [9] 427809 0
Nutritional impact symptoms
Timepoint [9] 427809 0
Six and twelve months after randomisation
Secondary outcome [10] 427810 0
Drug burden
Timepoint [10] 427810 0
Six and twelve months after randomisation
Secondary outcome [11] 427811 0
Medication complexity
Timepoint [11] 427811 0
Six and twelve months after randomisation
Secondary outcome [12] 427812 0
Potentially inappropriate medication
Timepoint [12] 427812 0
Six and twelve months after randomisation
Secondary outcome [13] 427813 0
Social frailty
Timepoint [13] 427813 0
Six and twelve months after randomisation
Secondary outcome [14] 427814 0
Perceived social support
Timepoint [14] 427814 0
Six and twelve months after randomisation
Secondary outcome [15] 427815 0
Adverse events
Timepoint [15] 427815 0
Six after randomisation
Secondary outcome [16] 427816 0
Healthcare use
Timepoint [16] 427816 0
Six months after randomisation
Secondary outcome [17] 427817 0
Integration of care
Timepoint [17] 427817 0
Six and twelve months after randomisation
Secondary outcome [18] 432941 0
Adherence to planned intervention schedule
Timepoint [18] 432941 0
Six months after randomisation
Secondary outcome [19] 432942 0
Website utilisation
Timepoint [19] 432942 0
Six months after randomisation
Secondary outcome [20] 432943 0
Acceptability of the intervention
Timepoint [20] 432943 0
Six months after randomisation
Secondary outcome [21] 432944 0
Goal attainment
Timepoint [21] 432944 0
Six and twelve months after randomisation
Secondary outcome [22] 434210 0
Mechanisms of impact
Timepoint [22] 434210 0
Six months after randomisation
Secondary outcome [23] 435631 0
Barriers to the intervention
Timepoint [23] 435631 0
12 months after randomisation
Secondary outcome [24] 435632 0
Enablers to the intervention
Timepoint [24] 435632 0
Twelve months after randomisation
Secondary outcome [25] 435633 0
Implementation of the intervention
Timepoint [25] 435633 0
Twelve months after randomisation
Secondary outcome [26] 435634 0
Mechanisms of impact
Timepoint [26] 435634 0
Twelve months after randomisation

Eligibility
Key inclusion criteria
1. Received a comprehensive geriatric assessment (CGA) at a public or private Australian geriatric medicine clinic/practice in the preceding 12 months and agree to the CGA's inclusion in the study;
2. Aged >=65 years, or >=55 years if Aboriginal or Torres Strait Islander;
3. Living in the community (i.e., not in aged care or hospitalised);
4. Have access and ability to use a computer or other electronic device with internet service (self-report);
5. Be able to travel to the exercise professional training sessions of their State; and
6. A frailty index between 0.15 and 0.30 (inclusive) as measured by Frailty Index Short Form.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. An estimated life expectancy of less than 12 months (e.g., due to a life-limiting condition) as assessed by their geriatrician;
2. Are unable to participate in a supervised and self-directed program due to cognitive impairment or another reason;
3. Have had self-reported in-patient hospital admission >24 hours in the past 3 months; and
4. Unable or unwilling to provide informed consent.

Study design
Purpose of the study
Treatment
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 (i.e. computerised sequence generation)
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
Efficacy
Statistical methods / analysis
With a sample of 195 in each intervention group, we would have 90% power for detecting a 0.03 unit change in the frailty index. This is based on a two-sample t-test with a common standard deviation of 0.075 (Theou et al, 2017), a two-sided alpha level of 0.05 and 30% attrition of participants where 0.03 frailty index units is the minimally important difference (Theou et al, 2020), and the average reduction in a pilot study aimed at reducing frailty in primary care (Theou et al, 2017),

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
30/07/2025
Actual
Date of last data collection
Anticipated
30/07/2026
Actual
Sample size
Target
390
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 315008 0
Government body
Name [1] 315008 0
Department of Health and Aged Care
Country [1] 315008 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 317030 0
Other Collaborative groups
Name [1] 317030 0
Australian Frailty Network
Address [1] 317030 0
Centre for Health Services Research, Building 33, Princess Alexandra Hosptial, Wooloongabba, QLD 4201
Country [1] 317030 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313979 0
Metro North Health HREC
Ethics committee address [1] 313979 0
Ethics committee country [1] 313979 0
Australia
Date submitted for ethics approval [1] 313979 0
04/10/2023
Approval date [1] 313979 0
02/11/2023
Ethics approval number [1] 313979 0
102635

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

Contacts
Principal investigator
Name 130002 0
Prof Ruth Hubbard
Address 130002 0
Centre for Health Services Research, Building 33, Princess Alexandra Hospital, 199 Ipswich road, Wooloongabba, QLD 4201
Country 130002 0
Australia
Phone 130002 0
+61 7 3443 8043
Fax 130002 0
Email 130002 0
[email protected]
Contact person for public queries
Name 130003 0
Natasha Reid
Address 130003 0
Centre for Health Services Research, Building 33, Princess Alexandra Hospital, 199 Ipswich road, Wooloongabba, QLD 4201
Country 130003 0
Australia
Phone 130003 0
+61 411 039 969
Fax 130003 0
Email 130003 0
[email protected]
Contact person for scientific queries
Name 130004 0
Natasha Reid
Address 130004 0
Centre for Health Services Research, Building 33, Princess Alexandra Hospital, 199 Ipswich road, Wooloongabba, QLD 4201
Country 130004 0
Australia
Phone 130004 0
+61 411 039 969
Fax 130004 0
Email 130004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identified data collected during the trial
When will data be available (start and end dates)?
Data will be available 2 years after the main outcomes are published, no end date
Available to whom?
Researchers who provide a methodologically sound proposal at the discretion of Sponsor.
Available for what types of analyses?
As approved by the Sponsor
How or where can data be obtained?
By emailing the sponsor at [email protected] and quoting the Fittest study


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.