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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
18/07/2019
Date data sharing statement initially provided
18/07/2019
Date results information 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
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
Secondary ID [1] 294893 0
Not applicable
Universal Trial Number (UTN)
Not applicable
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Concerns about falling 307849 0
Falls 308031 0
Condition category
Condition code
Injuries and Accidents 306893 306893 0 0
Other injuries and accidents
Mental Health 306894 306894 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 301205 0
Treatment: Other
Intervention code [2] 301206 0
Behaviour
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
Control group
Active

Outcomes
Primary outcome [1] 305888 0
Concerns about the consequences of falling using the Consequences of Falling (CoF) scale
Timepoint [1] 305888 0
At baseline and at 6 weeks after commencement of intervention
Secondary outcome [1] 346893 0
Concerns about the consequences of falling using the Consequences of Falling (CoF) scale.
Timepoint [1] 346893 0
At 6 months and 12 months after commencement of intervention.
Secondary outcome [2] 346894 0
Concerns about falls using the Iconographical Falls Efficacy Scale (Icon-FES).
Timepoint [2] 346894 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [3] 346895 0
Balance confidence using the Activities-specific Balance Confidence (ABC) scale.
Timepoint [3] 346895 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [4] 346897 0
Activity avoidance using the Iconographical Survey of Activities and Fear of Falling in the Elderly (Icon-SAFE).

Timepoint [4] 346897 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [5] 346898 0
Depression as measured by the Depression, Anxiety, Stress (DASS-21) depression subscale.
Timepoint [5] 346898 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [6] 346899 0
Anxiety as measured by the Depression Anxiety Stress (DASS-21) anxiety subscale.
Timepoint [6] 346899 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [7] 346900 0
Stress as measured by the Depression Anxiety Stress (DASS-21) stress subscale.
Timepoint [7] 346900 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [8] 346934 0
Questionnaire measure of depressive symptoms using the Patient Health Questiionnaire-9 (PHQ-9).
Timepoint [8] 346934 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [9] 346936 0
Physical activity level using the Incidental and Planned Exercise Questionnaire (IPEQ).
Timepoint [9] 346936 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [10] 346937 0
Self-efficacy to perform physical activity using the Exercise Self-Efficacy Scale (ESES).
Timepoint [10] 346937 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [11] 346938 0
Physical activity using the Dynaport MoveMonotor activity monitor (McRoberts, the Netherlands)
Timepoint [11] 346938 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [12] 346939 0
Health literacy levels using the Health Literacy Questionnaire (HLQ).
Timepoint [12] 346939 0
At baseline, 6 weeks, 6 months and 12 months after commencement of intervention.
Secondary outcome [13] 346940 0
Rate of falls in each group: Falls will be monitored with monthly fall calendars.
Timepoint [13] 346940 0
At 12 months after commencement of intervention.
Secondary outcome [14] 346941 0
The proportion of fallers in each group: Falls will be monitored with monthly fall calendars.
Timepoint [14] 346941 0
At 12 months after commencement of intervention.
Secondary outcome [15] 346943 0
Health care use recorded with monthly diaries.
Timepoint [15] 346943 0
At 12 months after commencement of intervention.
Secondary outcome [16] 346944 0
Adherence to the intervention recorded by the program and monitored following data transfer to server.
Timepoint [16] 346944 0
At 6 weeks after commencement of intervention. (intervention group only)
Secondary outcome [17] 347513 0
Usability of the intervention is assessed using the System Usability Scale.
Timepoint [17] 347513 0
At 6 weeks after commencement of intervention. (intervention group only)
Secondary outcome [18] 347514 0
Acceptability of the intervention is assessed using the Attitudes to Falls-Related Interventions Scale.
Timepoint [18] 347514 0
At 6 weeks after commencement of intervention. (intervention group only)

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
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint(s)
Efficacy
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).

Recruitment
Recruitment status
Active, not 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] 299476 0
Government body
Name [1] 299476 0
National Health and Medical Research Council
Address [1] 299476 0
GHD Building Level 1, 16 Marcus Clarke St
Canberra ACT 2601
Australia
Country [1] 299476 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Barker St
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 298777 0
Other
Name [1] 298777 0
Black Dog Institute
Address [1] 298777 0
Hospital Rd,
Prince of Wales Hospital,
Randwick NSW 2031
Country [1] 298777 0
Australia
Secondary sponsor category [2] 298913 0
University
Name [2] 298913 0
University of New South Wales
Address [2] 298913 0
High St
Kensington, NSW 2052
Australia
Country [2] 298913 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300382 0
Human Research Ethics Committee of the University of New South Wales
Ethics committee address [1] 300382 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
University of New South Wales
Sydney NSW 2052
Australia
Ethics committee country [1] 300382 0
Australia
Date submitted for ethics approval [1] 300382 0
Approval date [1] 300382 0
15/12/2017
Ethics approval number [1] 300382 0
HC17977

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83478 0
A/Prof Kim Delbaere
Address 83478 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031 Australia
Country 83478 0
Australia
Phone 83478 0
+61 2 93991066
Fax 83478 0
Email 83478 0
k.delbaere@neura.edu.au
Contact person for public queries
Name 83479 0
A/Prof Kim Delbaere
Address 83479 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031 Australia
Country 83479 0
Australia
Phone 83479 0
+61 2 93991066
Fax 83479 0
Email 83479 0
k.delbaere@neura.edu.au
Contact person for scientific queries
Name 83480 0
A/Prof Kim Delbaere
Address 83480 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031 Australia
Country 83480 0
Australia
Phone 83480 0
+61 2 93991066
Fax 83480 0
Email 83480 0
k.delbaere@neura.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
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary