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Trial registered on ANZCTR


Registration number
ACTRN12619001642178
Ethics application status
Approved
Date submitted
8/11/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing falls in mental health: a pilot RCT
Scientific title
A tailored falls prevention program for people aged 50+ with mental illness living in the community: A pilot randomised controlled trial.
Secondary ID [1] 299761 0
Nil known
Universal Trial Number (UTN)
U1111-1243-2271
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Mental illness 315123 0
Risk of falls 315124 0
Condition category
Condition code
Mental Health 313441 313441 0 0
Other mental health disorders
Injuries and Accidents 313587 313587 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Adapted Stepping On program
The intervention comprises a tailored program based on the Stepping On falls prevention program. The intervention materials include the Stepping On program manual (used by the program facilitator and available from Sydney University Press at https://sydneyuniversitypress.com.au/products/124823), program handouts (used by the program facilitator and participants which are available to download at no cost from Sydney University Press at https://sydneyuniversitypress.com.au/products/124823#) and simple equipment such as ankle weights and assistive devices that can be used in the home.

In this trial the Stepping On program will be tailored/adapted to the needs of older people with a mental illness who have an increased risk of falling compared to the typical older person living in the community. Program adaptations will be developed by an expert panel including mental health consumers.

The Stepping On program will be adapted to include eight weekly sessions (compared to seven sessions in a typical program) plus a booster session at one month (compared to three months in a typical program). This tailoring of the program will enable more time for and repetition of program content, allow more time for participants to practice the exercises, reduce the content of each session, expand on topics more relevant to older adults with mental health conditions and permit close follow up of participants to ensure continuation of the fall prevention strategies practiced during the program. Other adaptations include a greater use of visual (rather than text-based) educational materials, regular practice and simple progression of the program exercises and a greater focus on topics such as sleep and medication management.

Specific session topics will include:
Session 1: Introduction, overview and risk appraisal
Session 2: Exercise and moving about safely
Session 3: Home falls hazards
Session 4: Community safety and footwear
Session 5: Vision, transportation safety
Session 6: Medication management, sleeping better and mobility mastery experiences
Session 7: Vitamin D and calcium
Session 8: Reviewing and planning ahead
Session 9: One-month booster session

Activities in the program are based on a typical Stepping On program and include practice, discussion, educational content, decision-making, strategy development and sharing of experiences through story-telling. The program will be delivered by an allied health professional experienced in the delivery of Stepping On and be conducted in a community-based setting such as a community mental health service. Strength and balance exercises are effective in preventing falls, are an essential component of the Stepping On program and will be included in this trial. Exercise instruction will be provided by a physiotherapist. The balance and strength exercise manual used in the Stepping On program is available to download at no cost from the University of Sydney Press website at: https://cdn.shopify.com/s/files/1/2667/8266/files/Stepping_On_Balance_and_Strength_Manual.pdf?415. The manual will be used by participants to guide safe practice of the exercises at home and includes information on the types of exercises to do and how frequently they should be done. Adherence to the exercises will be monitored by the program facilitator through the use weekly exercise records maintained by the program participants. Adherence to the program will be measured using a program attendance sheet.
Intervention code [1] 316017 0
Prevention
Comparator / control treatment
The control group will receive their usual care as offered by the Older Person's Mental Health Service.
Control group
Active

Outcomes
Primary outcome [1] 321916 0
The number of falls experienced by participants after the program. This outcome will be measured in two ways: 1) through review of participants’ medical records to determine falls- related events prior to and after the program and 2) participant self-reported data recorded on a falls calendar.
Timepoint [1] 321916 0
Three months (at program completion) and 12 months (post program completion).
Secondary outcome [1] 376703 0
Falls risk will be measured using the Falls Risk for Older People – Community setting (FROP-COM)(Russel et al, 2008).
Timepoint [1] 376703 0
Three months (at program completion)
Secondary outcome [2] 376704 0
Balance, strength and mobility will be measured using the Short Physical Performance Battery (SPPB)(Lauretani et al, 2018).
Timepoint [2] 376704 0
Three months (at program completion)
Secondary outcome [3] 376705 0
Falls self-efficacy will be measured using the Falls Efficacy Scale – International (FES-I)(Yardley et al, 2005).

Timepoint [3] 376705 0
Three months (at program completion)
Secondary outcome [4] 376706 0
Falls risk in the home environment will be measured using the Home Falls and Accident Screening Program (HOME FAST)(Mackenzie et al, 2002).
Timepoint [4] 376706 0
Three months (at program completion)

Eligibility
Key inclusion criteria
• Consumers aged 50 years or over.
• Have a mental health diagnosis.
• Not in an acute phase of their illness
• Living in the community.
• Registered with the Older Person’s Mental Health Service at two sites in Sydney, Australia.
• Be eligible and willing to participate in the adapted Stepping On program: had fall in the past year or fearful of falling, Independent in walking with or without a walking stick, cognitively intact (no evidence of dementia) and bble to understand and converse in English.
• Willing to provide written informed consent.to participate in the study.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participants who are too ill to participate in the program or experience an acute episode of their condition will be excluded from the study.
• Residents of residential aged care facilities.
• Those with a dementia diagnosis

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to groups will occur using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved using simple randomisation using coin-tossing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: This project consists of a small sample size, and is an exploratory project being conducted to address an issue about which little is known. The proposed sample size is feasible for the funded study period. This project therefore, will be a pilot project to evaluate if a future larger project is feasible and to identify best methods to use.

Statistical analysis plan: Data will be managed for each study participant who will receive an ID number, and any data relating to participants will be entered into a database and statistical program (SPSS). Demographic and diagnostic information will be analysed and summarised using descriptive statistics. Outcome data will be analysed using an intention-to-treat approach. Between-groups differences in outcomes will be analysed using non-parametric statistics with a significance level set at 0.05.

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)
NSW

Funding & Sponsors
Funding source category [1] 304228 0
Government body
Name [1] 304228 0
Medical Research Future Fund Rapid Applied Research Translation Program
Address [1] 304228 0
Australian Government Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
Country [1] 304228 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 304467 0
None
Name [1] 304467 0
Address [1] 304467 0
Country [1] 304467 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304689 0
Northern Sydney Local Health District – HREC
Ethics committee address [1] 304689 0
Research Office
Kolling Building Level 13
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 304689 0
Australia
Date submitted for ethics approval [1] 304689 0
29/08/2019
Approval date [1] 304689 0
11/11/2019
Ethics approval number [1] 304689 0
2019/ETH10457: General Amendment

Summary
Brief summary
The purpose of this study is to evaluate if a tailored fall prevention program can reduce falls, reduce the risk factors for falls and improve balance, strength, confidence and the home environment for older people with a mental illness living in the community. The intervention in this study will be adapted from the Stepping On fall prevention program, which has been shown to reduce falls in typical older people living in the community. By adapting this program to the needs of older people with a mental illness, we hypothesise that these adaptations will results in improved falls and other fall-related outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97874 0
Dr Meryl Lovarini
Address 97874 0
Discipline of Occupational Therapy
The University of Sydney
75 East Street
Lidcombe NSW 2141
Country 97874 0
Australia
Phone 97874 0
+61 407 926 958
Fax 97874 0
+61 2 9351 9197
Email 97874 0
meryl.lovarini@sydney.edu.au
Contact person for public queries
Name 97875 0
Dr Meryl Lovarini
Address 97875 0
Discipline of Occupational Therapy
The University of Sydney
75 East Street
Lidcombe NSW 2141
Country 97875 0
Australia
Phone 97875 0
+61 407 926 958
Fax 97875 0
+61 2 9351 9197
Email 97875 0
meryl.lovarini@sydney.edu.au
Contact person for scientific queries
Name 97876 0
Dr Meryl Lovarini
Address 97876 0
Discipline of Occupational Therapy
The University of Sydney
75 East Street
Lidcombe NSW 2141
Country 97876 0
Australia
Phone 97876 0
+61 407 926 958
Fax 97876 0
+61 2 9351 9197
Email 97876 0
meryl.lovarini@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be shared in accordance with the requirements of the approving ethical committee.
What supporting documents are/will be available?
No other documents available
Summary results
No Results