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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
28/09/2022
Date data sharing statement initially provided
25/11/2019
Date results provided
28/09/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Preventing falls in mental health: a pilot RCT
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Scientific title
A tailored falls prevention program for people aged 50+ with mental illness living in the community: A pilot randomised controlled trial.
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Secondary ID [1]
299761
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Nil known
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Universal Trial Number (UTN)
U1111-1243-2271
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Trial acronym
Nil
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Linked study record
Nil
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Health condition
Health condition(s) or problem(s) studied:
Mental illness
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Risk of falls
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Condition category
Condition code
Mental Health
313441
313441
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0
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Other mental health disorders
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Injuries and Accidents
313587
313587
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0
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Fractures
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
316017
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Prevention
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Comparator / control treatment
The control group will receive their usual care as offered by the Older Person's Mental Health Service.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Three months (at program completion) and 12 months (post program completion).
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Secondary outcome [1]
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Falls risk will be measured using the Falls Risk for Older People – Community setting (FROP-COM)(Russel et al, 2008).
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Assessment method [1]
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Timepoint [1]
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Three months (at program completion)
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Secondary outcome [2]
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Balance, strength and mobility will be measured using the Short Physical Performance Battery (SPPB)(Lauretani et al, 2018).
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Assessment method [2]
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Timepoint [2]
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Three months (at program completion)
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Secondary outcome [3]
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Falls self-efficacy will be measured using the Falls Efficacy Scale – International (FES-I)(Yardley et al, 2005).
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Assessment method [3]
376705
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Timepoint [3]
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Three months (at program completion)
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Secondary outcome [4]
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Falls risk in the home environment will be measured using the Home Falls and Accident Screening Program (HOME FAST)(Mackenzie et al, 2002).
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Assessment method [4]
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Timepoint [4]
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Three months (at program completion)
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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.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to groups will occur using sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved using simple randomisation using coin-tossing.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
13/01/2021
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Actual
13/01/2021
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Date of last participant enrolment
Anticipated
28/02/2022
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Actual
29/01/2021
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Date of last data collection
Anticipated
29/07/2022
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Actual
31/12/2021
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Sample size
Target
40
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Accrual to date
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Final
11
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Medical Research Future Fund Rapid Applied Research Translation Program
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Address [1]
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Australian Government Department of Health
GPO Box 9848
Canberra ACT 2601
Australia
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
Camperdown NSW 2006
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
304467
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Country [1]
304467
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304689
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Northern Sydney Local Health District – HREC
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Ethics committee address [1]
304689
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Research Office Kolling Building Level 13 Royal North Shore Hospital St Leonards NSW 2065
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Ethics committee country [1]
304689
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Australia
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Date submitted for ethics approval [1]
304689
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29/08/2019
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Approval date [1]
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11/11/2019
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Ethics approval number [1]
304689
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2019/ETH10457: General Amendment
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Meryl Lovarini
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Address
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Discipline of Occupational Therapy, Sydney School of Health Sciences, Faculty of Medicine and Health. D18 - Susan Wakil Health Building, Level 7 - West, The University of Sydney NSW 2006 Australia
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Country
97874
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Australia
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Phone
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+61 407 926 958
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Fax
97874
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+61 2 9351 9197
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Email
97874
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meryl.lovarini@sydney.edu.au
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Contact person for public queries
Name
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Meryl Lovarini
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Address
97875
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Discipline of Occupational Therapy, Sydney School of Health Sciences, Faculty of Medicine and Health. D18 - Susan Wakil Health Building, Level 7 - West, The University of Sydney NSW 2006 Australia
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Country
97875
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Australia
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Phone
97875
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+61 407 926 958
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Fax
97875
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+61 2 9351 9197
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Email
97875
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meryl.lovarini@sydney.edu.au
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Contact person for scientific queries
Name
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Meryl Lovarini
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Address
97876
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Discipline of Occupational Therapy, Sydney School of Health Sciences, Faculty of Medicine and Health. D18 - Susan Wakil Health Building, Level 7 - West, The University of Sydney NSW 2006 Australia
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Country
97876
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Australia
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Phone
97876
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+61 407 926 958
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Fax
97876
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+61 2 9351 9197
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Email
97876
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meryl.lovarini@sydney.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Individual participant data will not be shared in accordance with the requirements of the approving ethical committee.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Conference poster
No
Lovarini M, Mackenzie L, Scanlan J, Hancock N, Bai...
[
More Details
]
378704-(Uploaded-27-09-2022-15-53-02)-Other results publication.pdf
Other files
No
Lovarini M, Mackenzie L, Scanlan J, Hancock N, Cle...
[
More Details
]
378704-(Uploaded-27-09-2022-15-55-06)-Other results publication.pdf
Documents added automatically
No additional documents have been identified.
Download to PDF