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Trial registered on ANZCTR


Registration number
ACTRN12620000533998p
Ethics application status
Submitted, not yet approved
Date submitted
3/03/2020
Date registered
30/04/2020
Date last updated
30/04/2020
Date data sharing statement initially provided
30/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Being Your Best, a holistic approach to frailty through eating, connecting, moving and/or thinking.
Scientific title
Being Your Best - an innovative, codesigned approach to frailty and care transitions from hospital to home, in people aged 65 years or more
Secondary ID [1] 300704 0
NIl
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 316518 0
Condition category
Condition code
Public Health 314760 314760 0 0
Other public health
Diet and Nutrition 314861 314861 0 0
Other diet and nutrition disorders
Musculoskeletal 314862 314862 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Being Your Best program will provide evidence-based modules that address the frailty domains of physical function, cognitive impairment, malnutrition and social isolation with an integrated, coordinated community-based approach.
What is novel in our approach is the participant choice of intervention modules. The choice of module(s) will be person-driven, of 6 months duration, and participants will report on completion of activities using a monthly calendar submitted to the project team. The participants GPs will be consulted and informed of the program prior to participant commencement.
Activities will be group- and community- based, where possible, with design input from consumer advisory groups and clinical staff from each participating health service. The advisory groups will provide input on name and desire for the suggested interventions, and long-term sustainability.
This program aims to recruit participants in emergency departments in 3 major Melbourne hospitals. We have conducted a service mapping of 188 services. Service mapping conducted has included 5 km radius around each participating site. One of the eligibility criteria to participate in this study is that the participant resides within this area. This has been included to ease the accessibility to a chosen community group. Home activities will be offered to those that prefer staying at home if the participant chooses to conduct individual activities, examples of those will be provided as well.
Once a participant has been recruited, they will be contacted by a Bolton Clarke research member to organise a home visit. During that visit, the participant and the research member will discuss options most suited to the individual participant. The participant’s GP will also be contacted and consulted regarding the participants safety to be a part of the programs of their choosing, before they can commence.
Some examples of service offerings to help prevent progression of frailty are as follows:
Cognition: Library services (computer skills workshop, other events, free wifi, computers), Men's Shed provides an opportunity for men to get together in a social environment to help with personal and community projects. Community centres (book clubs, knitting club, games club, English language café, Greek senior citizens club). Free of cost online training modules such as Lumosity and Word search will be offered as well as free of cost crossword puzzles, sudoku, 9-letter word etc
Exercise: Bowls clubs (membership include eligibility for pennant sides, bowls competitions, bar and facilities, sponsor benefits), community walking groups. Aquatic and leisure centres: swimming. For individual activities, pamphlets will be provided after consultation with the participants GP
Social support: U3A clubs (get together with other members of the community, classes and group activities), Senior citizen's clubs (services include lunches, day trips, hairdresser, podiatrists). We will also be providing telephone support for those participants that prefer telephone support.
Nutritional support: Services such as casserole clubs and cooking classes will be offered. Recipes for easy to make nutritional foods will also be presented as an option.
All the above interventions are some examples from out service mapping. The number of times an intervention will be delivered is individual, we are hoping that the activities will be conducted weekly and according to government recommendations. To this note, we are asking the participants to fill out activity logs. All suggested interventions will be drafted according to The Australian Department of Health recommendations health for older Australians (https://www1.health.gov.au/internet/main/publishing.nsf/Content/phd-physical-rec-older-guidelines).

The intervention part of this study will continue for six months and the participants will be contacted by phone at one, three and six months post commencement to discuss how they are going. They will also be contacted one year after commencement in hope that they have continued with chosen activity or have chosen a different activity. The end result is to help improve the participants health and well-being and with that decrease the symptoms of frailty.

Intervention code [1] 317025 0
Lifestyle
Intervention code [2] 317101 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323109 0
Frailty will be assessed by The Modified Reported Edmonton Frail Scale (mod-REFS) - This is a validated scale used to measure mental and physical frailty and pre frailty
Timepoint [1] 323109 0
1 month post-enrollment
3 months post-enrollment
6 months post-enrollment
12 months (primary outcome) post-enrollment
Secondary outcome [1] 380803 0
Any hospital, GP, specialist or allied health appointments/admissions. We will ask the enrolled participant for that information.
Timepoint [1] 380803 0
1, 3, 6, and 12 months post-enrollment
Secondary outcome [2] 380804 0
Ability to perform activities of daily living - Barthel Index: A functional, validated, health questionnaire used to measure the participants ability to manage activities of daily living (ADL).
Timepoint [2] 380804 0
1, 3, 6, and 12 months post-enrollment
Secondary outcome [3] 380805 0
Cognitive impairment - Mini Mental State Exam (MMSE): This is a widely used validated, tool to assess cognitive function
Timepoint [3] 380805 0
1, 3, 6, and 12 months post-enrollment
Secondary outcome [4] 380806 0
Loneliness - will be measured by ised the scale: University of California, Los Angeles Loneliness Scale – 3 items (UCLA-3). This scale is a simple and reliable three item scale to measure loneliness and feelings of social isolation
Timepoint [4] 380806 0
1, 3, 6, and 12 months post-enrollment
Secondary outcome [5] 381648 0
Ability to live independently in the community - Lawton Instrumental Activities of Daily Living (IADL) scale will be used - This scale is designed to assess an individuals ability to live independently in a community
Timepoint [5] 381648 0
1, 3, 6, and 12 months post-enrollment

Eligibility
Key inclusion criteria
- Age grater than or equal to 65 years
- Resides in community dwelling
- Recent presentation to ED
- Score rater than or equal to 6 (pre-frail, mildly frail, moderately frail, or severely frail) on the Modified Edmonton Frailty Scale (Mod-REFS)
- Able to communicate in English
- Able to provide written informed
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current aged care home resident
- To be discharged to residential aged care
- To be discharged to rehabilitation
- Receiving terminal or end-of-life care
- Surgical or Intensive Care Unit (ICU) admission
- Residing >10km from hospital recruitment

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305149 0
Other Collaborative groups
Name [1] 305149 0
Monash Partners Medical Research Future Fund (MRFF) Rapid Applied Research Translation
Address [1] 305149 0
246 Clayton Road, Clayton 3168 VIC
Country [1] 305149 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Bolton Clarke
Address
Suite 1.01, 973 Nepean Highway Bentleigh, VIC 3204
Country
Australia
Secondary sponsor category [1] 305506 0
None
Name [1] 305506 0
Address [1] 305506 0
Country [1] 305506 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305514 0
Monash Partners Human Research Ethics Commitee
Ethics committee address [1] 305514 0
246 Clayton Road, Clayton, VIC 3168
Ethics committee country [1] 305514 0
Australia
Date submitted for ethics approval [1] 305514 0
12/11/2019
Approval date [1] 305514 0
Ethics approval number [1] 305514 0

Summary
Brief summary
Frailty is a condition in which the individual is vulnerable and at increased risk of poor health outcomes or death when exposed to a stressor, such as illness or injury. As we age, frailty is common, affecting up to one in two people aged 65 years or more. The Being Your Best program, codesigned with health consumers, will address frailty in people aged 65 years and above.
This proposal outlines two stages of work:
Firstly, codesign of the Being Your Best program will be undertaken with health consumer representatives, including carers/nominated family members or persons (NFMPs), to understand their perspectives on how a set of frailty interventions may be best designed with their needs in mind.
Secondly, we will undertake a feasibility and acceptability study of the Being Your Best program that will test the interventions developed in the codesign phase. This phase involves a needs-based assessment of people aged 65 years and above, and choice of existing community- or home-based interventions to prevent or overcome frailty. Interventions will address physical function through exercise (emphasising strength training), nutritional support, cognitive stimulation, and/or social support. Much of the detail around the design of this second phase will be determined by the outcomes of the initial codesign phase of work.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100634 0
Prof Judy Lowthian
Address 100634 0
Bolton Clarke Research Institute
Suite 1.01, 973 Nepean Highway Bentleigh, VIC 3204
Country 100634 0
Australia
Phone 100634 0
+61 412 116 571
Fax 100634 0
Email 100634 0
jlowthian@boltonclarke.com.au
Contact person for public queries
Name 100635 0
Dr Maja Green
Address 100635 0
Bolton Clarke Research Institute
Suite 1.01, 973 Nepean Highway Bentleigh, VIC 3204
Country 100635 0
Australia
Phone 100635 0
+61 452428058
Fax 100635 0
Email 100635 0
mgreen2@boltonclarke.com.au
Contact person for scientific queries
Name 100636 0
Dr Maja Green
Address 100636 0
Bolton Clarke Research Institute
Suite 1.01, 973 Nepean Highway Bentleigh, VIC 3204
Country 100636 0
Australia
Phone 100636 0
+61 452428058
Fax 100636 0
Email 100636 0
mgreen2@boltonclarke.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results