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Trial registered on ANZCTR
Registration number
ACTRN12618000926235
Ethics application status
Approved
Date submitted
22/05/2018
Date registered
31/05/2018
Date last updated
17/11/2021
Date data sharing statement initially provided
18/07/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
StandingTall-plus Balance Confidence: an online cognitive behavioural therapy program to address concerns about falling in older people
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Scientific title
Evaluating the efficacy of an online cognitive behavioural therapy program on concerns about falling in community-dwelling older people: a randomised controlled trial
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Secondary ID [1]
294893
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Not applicable
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Universal Trial Number (UTN)
Not applicable
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Trial acronym
Not applicable
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Linked study record
Not applicable
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Health condition
Health condition(s) or problem(s) studied:
Concerns about falling
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Falls
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Condition category
Condition code
Injuries and Accidents
306893
306893
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0
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Other injuries and accidents
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Mental Health
306894
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention consists of a fully-automated cognitive behavioural therapy program (myCompass) delivered through a tablet or computer in people’s homes with no therapist input. The myCompass program offers evidence-based and interactive psychological modules that users can complete via the internet on a tablet or computer in their homes. For purposes of the study, the participant will be offered 3 skill-building modules derived from cognitive behavioural therapy, Interpersonal Psychotherapy, Problem-solving Therapy and Positive Psychology that cover the topics of “Managing Fear and Anxiety”, “Taking Charge of Your Worry” and “Solving Problems”. Each module comprises three 10-minute sessions and includes activities for users to complete on the computer. There are home practice tasks recommended for participants to complete between the online sessions (i.e. completion of one full module per week followed by 1 week of practice), which are intended to promote skill generalisation. Participants will have 6 weeks to undertake the myCompass program.
* Following the baseline assessment at Neuroscience Research Australia, someone from the research team will explain to the participant how to use the ‘myCompass’ program.
* Participants will be given their own login and password to access the myCompass program via a specific web address.
* Tablets will be provided for participants without home computers or internet access.
* Participant adherence will be examined weekly by the research team. Participants not engaging with myCompass for the week will be contacted by telephone to discuss any issues pertaining to adherence.
* Phone and email support will be available as needed for the entire duration of the study (6 weeks).
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Intervention code [1]
301205
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Treatment: Other
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Intervention code [2]
301206
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Behaviour
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Comparator / control treatment
Both groups will receive a health promotion education program with a focus on general health concerns relevant to older adults (active lifestyles, blood pressure, healthy diet, falls and fear of falling). A paper-based health promotion booklet will be provided to the participants to read during the 6 weeks. The program has no therapeutic content, and has been successfully used as a placebo in previous studies by members of the research team. Adherence will be tracked using weekly self-reported written logs.
* Following the baseline assessment at Neuroscience Research Australia, the educational booklet will be provided to the participants
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Control group
Active
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Outcomes
Primary outcome [1]
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Concerns about the consequences of falling using the Consequences of Falling (CoF) scale
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Assessment method [1]
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Timepoint [1]
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At baseline and at 6 weeks after commencement of intervention
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Secondary outcome [1]
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Concerns about the consequences of falling using the Consequences of Falling (CoF) scale.
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Assessment method [1]
346893
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Timepoint [1]
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At 6 months and 12 months after commencement of intervention.
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Secondary outcome [2]
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Concerns about falls using the Iconographical Falls Efficacy Scale (Icon-FES).
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Assessment method [2]
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Timepoint [2]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [3]
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Balance confidence using the Activities-specific Balance Confidence (ABC) scale.
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Assessment method [3]
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Timepoint [3]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [4]
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Activity avoidance using the Iconographical Survey of Activities and Fear of Falling in the Elderly (Icon-SAFE).
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Assessment method [4]
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Timepoint [4]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [5]
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Depression as measured by the Depression, Anxiety, Stress (DASS-21) depression subscale.
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Assessment method [5]
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Timepoint [5]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [6]
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Anxiety as measured by the Depression Anxiety Stress (DASS-21) anxiety subscale.
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Assessment method [6]
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Timepoint [6]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [7]
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Stress as measured by the Depression Anxiety Stress (DASS-21) stress subscale.
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Assessment method [7]
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Timepoint [7]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [8]
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Questionnaire measure of depressive symptoms using the Patient Health Questiionnaire-9 (PHQ-9).
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Assessment method [8]
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Timepoint [8]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [9]
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Physical activity level using the Incidental and Planned Exercise Questionnaire (IPEQ).
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Assessment method [9]
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Timepoint [9]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [10]
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Self-efficacy to perform physical activity using the Exercise Self-Efficacy Scale (ESES).
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Assessment method [10]
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Timepoint [10]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [11]
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Physical activity using the Dynaport MoveMonotor activity monitor (McRoberts, the Netherlands)
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Assessment method [11]
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Timepoint [11]
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [12]
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Health literacy levels using the Health Literacy Questionnaire (HLQ).
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Assessment method [12]
346939
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Timepoint [12]
346939
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At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
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Secondary outcome [13]
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Rate of falls in each group: Falls will be monitored with monthly fall calendars.
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Assessment method [13]
346940
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Timepoint [13]
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At 12 months after commencement of intervention.
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Secondary outcome [14]
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The proportion of fallers in each group: Falls will be monitored with monthly fall calendars.
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Assessment method [14]
346941
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Timepoint [14]
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At 12 months after commencement of intervention.
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Secondary outcome [15]
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Health care use recorded with monthly diaries.
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Assessment method [15]
346943
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Timepoint [15]
346943
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At 12 months after commencement of intervention.
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Secondary outcome [16]
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Adherence to the intervention recorded by the program and monitored following data transfer to server.
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Assessment method [16]
346944
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Timepoint [16]
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At 6 weeks after commencement of intervention. (intervention group only)
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Secondary outcome [17]
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Usability of the intervention is assessed using the System Usability Scale.
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Assessment method [17]
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Timepoint [17]
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At 6 weeks after commencement of intervention. (intervention group only)
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Secondary outcome [18]
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Acceptability of the intervention is assessed using the Attitudes to Falls-Related Interventions Scale.
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Assessment method [18]
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Timepoint [18]
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At 6 weeks after commencement of intervention. (intervention group only)
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Eligibility
Key inclusion criteria
-65 years of age and older
-Concerned about falls and/or have low balance confidence
-Living in the community
-English-speaking
-Independent in activities of daily living
-Able to walk household distances with or without the use of a walking aid
-Willing to give informed consent and comply with the study protocol
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Minimum age
65
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?
Yes
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Key exclusion criteria
* Inability to read English with ease
* Current participation in a fall prevention program
* Cognitive impairment defined by the Pfeiffer Short Portable Mental Status Questionnaire (SPMSQ) score<8
* Severe depression defined by the Patient Health Questionnaire (PHQ-9) score >=20
* Progressive neurological disease or any other unstable or acute medical condition precluding exercise
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Study design
Purpose of the study
Treatment
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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)
Potential participants will be screened to assess eligibility over the phone. Eligible participants will then proceed to perform the baseline assessment at NeuRA. All participants will be assessed at baseline on the Physiological Profile Assessment (estimate of physiological fall risk) and trail-making tests (measure of executive function). Demographic and general health details of the participants will also be obtained during the assessment. Following the baseline assessment, participants will be randomly allocated to either the intervention or control group. Sealed opaque envelopes containing the group allocation will be opened by an unblinded research team member after the baseline assessment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be determined using a computer generated random number schedule. The person performing the randomisation will not be involved in any assessments of this study.
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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
Not applicable
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Statistical analyses will be performed using SPSS. Characteristics of the two groups at baseline will be compared using chi-square tests for categorical data and t-tests for continuous data. Primary and secondary outcomes will be evaluated using a mixed models repeated measures approach with maximum likelihood estimation for missing data. Supplementary analyses will compare data for people with higher and lower levels of adherence.
A sample size calculation (p<0.05, power= 0.8) indicated that a total sample size of 50 participants will be needed to observe an effect on the primary outcome measure of concerns about consequences of falling. The estimated sample size is based on the effects of a previous study which had tested the effect of CBT on concerns about falls, consequences of falling, balance confidence and activity avoidance (effect size d=0.4, Alpha 5%, Power 80%, Numerator df 1, Number of groups 2, 20% drop-out) (Zijlstra et al, 2009).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
4/06/2018
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Actual
12/06/2018
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Date of last participant enrolment
Anticipated
31/12/2018
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Actual
20/07/2018
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Date of last data collection
Anticipated
31/12/2019
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Actual
31/08/2019
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Sample size
Target
50
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Accrual to date
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Final
50
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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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National Health and Medical Research Council
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Address [1]
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GHD Building Level 1, 16 Marcus Clarke St
Canberra ACT 2601
Australia
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Country [1]
299476
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Australia
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Primary sponsor type
Other
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Name
Neuroscience Research Australia
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Address
Barker St
Randwick NSW 2031
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Country
Australia
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Secondary sponsor category [1]
298777
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Other
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Name [1]
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Black Dog Institute
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Address [1]
298777
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Hospital Rd,
Prince of Wales Hospital,
Randwick NSW 2031
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Country [1]
298777
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Australia
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Secondary sponsor category [2]
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University
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Name [2]
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University of New South Wales
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Address [2]
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High St
Kensington, NSW 2052
Australia
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Country [2]
298913
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300382
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Human Research Ethics Committee of the University of New South Wales
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Ethics committee address [1]
300382
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Ethics Secretariat UNSW Grants Management Office Rupert Myers Building, Level 3, South Wing University of New South Wales Sydney NSW 2052 Australia
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Ethics committee country [1]
300382
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Australia
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Date submitted for ethics approval [1]
300382
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Approval date [1]
300382
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15/12/2017
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Ethics approval number [1]
300382
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HC17977
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Summary
Brief summary
The aim of this study to assess the effectiveness of an online cognitive behavioural program (myCompass) versus a health education program for 6 weeks at reducing concerns about falling in community-dwelling older people. The primary outcome (concern about consequences of falling) and secondary outcomes (concerns about falls, balance confidence, activity avoidance, depression, anxiety, health literacy and physical activity) will be measured in the form of a randomised controlled trial.
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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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A/Prof Kim Delbaere
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Address
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Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031 Australia
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Country
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Australia
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Phone
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+61 2 93991066
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Fax
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Email
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k.delbaere@neura.edu.au
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Contact person for public queries
Name
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Kim Delbaere
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Address
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Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031 Australia
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Country
83479
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Australia
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Phone
83479
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+61 2 93991066
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Fax
83479
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Email
83479
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k.delbaere@neura.edu.au
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Contact person for scientific queries
Name
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Kim Delbaere
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Address
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Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031 Australia
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Country
83480
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Australia
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Phone
83480
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+61 2 93991066
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Fax
83480
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Email
83480
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k.delbaere@neura.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
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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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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