Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000440820
Ethics application status
Approved
Date submitted
9/03/2020
Date registered
16/04/2021
Date last updated
28/06/2023
Date data sharing statement initially provided
16/04/2021
Date results information initially provided
28/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Own Your Balance Study : Effect of a self-managed online cognitive behavioural therapy program in older people with concerns about falling
Scientific title
Evaluating the efficacy of a self-managed online cognitive behavioural therapy program with or without an additional graded balance program in community-dwelling older people: a randomised controlled trial.
Secondary ID [1] 300671 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concerns about falling 316405 0
Falls 316470 0
Condition category
Condition code
Mental Health 314716 314716 0 0
Other mental health disorders
Injuries and Accidents 314717 314717 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised controlled trial will comprise of two intervention and one control group. One intervention group will receive the Own Your Balance program and one intervention group will receive the Own Your Balance program plus the StandingTall graded activity program – both delivered through a tablet or computer in people’s homes with limited therapist input over a period of 8 weeks. At the end of 8 weeks, both groups will receive individual guidance over the phone, using motivational interviewing techniques, to use the Active and Healthy website to continue with an exercise program (at least 2 hours of exercise each week) for the next 10 months. A follow-up call will be done at 12 weeks to see if the participants in both intervention groups have started with their exercise program.

(i) The Own Your Balance program consists of two components, i.e. the online myCompass program and a workbook. The myCompass program offers 14 skill-building modules that cover a wide range of topics such as “Managing Fear and Anxiety”, “Taking Charge of Your Worry” and “Solving Problems”. Each module comprises 3x10min sessions. Participants will be asked to complete at least 3 modules during the 8-week program. Participants will also be given the Own Your Balance workbook to complete during the 8-week program which provides weekly psycho-education chapters on falls and concerns about falling. The content of the program is derived from Cognitive Behavioural Therapy, Interpersonal Psychotherapy, Problem-solving Therapy and Positive Psychology. There are home practice tasks for participants to complete (i.e. completion of one full module per week followed by 1 week of practice), which are intended to promote skill generalisation. Each chapter from the workbook will take approximately 15 minutes to complete. After the 8-week program, participants from both intervention groups can continue to use the Own Your Balance program. Participants will receive a 30-minute induction to myCompass via telehealth, during which they will be setup with the program and guided to use it.

(ii) The graded activity balance program is the StandingTall program, which delivers personalised exercises that automatically increase in difficulty over time. It uses mobile technology to provide home-based unsupervised exercises with compliance-promoting features by providing feedback, goal-setting, monitoring and sending of reminders. The program comprises standing on an unsteady surface (e.g. a foam surface), transferring (e.g. sit-stand transitions), walking (e.g. walking in circles or to targets in a grid), stepping (e.g. step and lift) and box (e.g. step up and over a box) exercises. The StandingTall program offers an effective way for people to improve their balance and reduce their fall risk. The program starts with 40min of training in week 1, using a paced approach to sustainably build towards a weekly target of 120min from week 3 to 8. Participants will receive a 90-min induction to StandingTall via telehealth, during which they will be setup with the program and guided to safely use it.

Ongoing exercise participation for both intervention groups beyond the 8-week program will be facilitated through the New South Wales Active and Healthy website (www.activeandhealthy.nsw.gov.au) to continue with a pandemic-safe exercise program. This website provides detailed descriptions of evidence-based exercise fall prevention classes and assists older people to find an appropriate exercise program that is available to them.

- Following a baseline assessment, an exercise physiologist from the research team will conduct a teleconference with the intervention group participants. Participants receiving the Own Your Balance program will undertake a 30 minute setup call. Participants also receiving the StandingTall program will undertake an additional 90 minute setup call.

- Both intervention groups will receive a weekly online health promotion education program with a focus on general health concerns (e.g. medications, blood pressure, healthy diet) relevant to older people. Participants will be asked to read the fact sheets weekly during the 8-week period. The program will be provided to the participants through a website with weekly updates. Adherence will be tracked automatically through the website.

- One intervention group will receive the Own Your Balance program and one intervention group will receive Own Your Balance plus the StandingTall graded activity program – both delivered through a tablet computer.

- StandingTall participants will receive additional instructions on how to perform the exercises safely.

- Participant adherence (training duration and frequency) to the StandingTall program will be monitored following automatic data transfer to a server and examined weekly. Participants not engaging with the StandingTall program for two consecutive weeks will be contacted by telephone to discuss any issues pertaining adherence by the (unblinded) research assistant.

- Further phone and email support will be available as needed for the duration of the study. A follow-up call will be done at 4 weeks for intervention group participants to see how they are progressing with the Own Your Balance program (i.e. myCompass and the workbook). At 12 weeks, another follow-up call will be given to see if the participants in both intervention groups have started with their exercise program.

- Participants will be asked to use their own devices where possible and will be provided with the devices for the duration of the study if required.
Intervention code [1] 316961 0
Lifestyle
Intervention code [2] 316999 0
Behaviour
Comparator / control treatment
Control group participants will only receive a weekly online health promotion education program with a focus on general health concerns (e.g. medications, blood pressure, healthy diet) relevant to older people. Participants will be asked to read the fact sheets (designed specifically for this study) weekly during the 8-week period. The program will be delivered to the participants through a weekly email with a link to the website with weekly updates. Adherence will be tracked automatically through the website.
Control group
Active

Outcomes
Primary outcome [1] 323065 0
Concerns about falling using the Iconographical Falls Efficacy Scale (IconFES).
Timepoint [1] 323065 0
At baseline and 12 months after commencement of intervention.
Secondary outcome [1] 380643 0
Balance confidence using the the Activities-specific Balance Confidence (ABC) scale.
Timepoint [1] 380643 0
At baseline, 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [2] 380644 0
Activity avoidance using the Iconographical Survey of Activities and Fear of Falling in the Elderly (IconSAFE) scale.
Timepoint [2] 380644 0
At baseline, 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [3] 380645 0
Overall movement intensity using the McRoberts MoveMonitor activity monitor
Timepoint [3] 380645 0
At baseline, 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [4] 380646 0
Habitual daily activity using the McRoberts MoveMonitor activity monitor.
Timepoint [4] 380646 0
At baseline, 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [5] 380647 0
Physical activity using the Incidental and Planned Exercise Questionnaires (IPEQ).
Timepoint [5] 380647 0
At baseline, 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [6] 380648 0
Enjoyment for physical activity as measured by the Physical Activity Enjoyment Scale (intervention groups only)
Timepoint [6] 380648 0
At 2 months after commencement of intervention.
Secondary outcome [7] 380649 0
Social activity using the Medical Outcomes Study Social Support Survey Questionnaire.
Timepoint [7] 380649 0
At baseline, 6 months and 12 months after commencement of intervention.
Secondary outcome [8] 380650 0
Exercise Self Efficacy using the Exercise Self Efficacy Scale (ESES).
Timepoint [8] 380650 0
At baseline, 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [9] 380754 0
Rate of falls in each group: Falls will be monitored with monthly fall calendars.
Timepoint [9] 380754 0
Monthly after commencement of intervention for a maximum of 12 months
Secondary outcome [10] 380755 0
Efficacy of treatment using the Patient Global Impression of Change Scale.
Timepoint [10] 380755 0
At 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [11] 380756 0
Adherence to the intervention recorded by the program and monitored following data transfer to a secure server.
Timepoint [11] 380756 0
At 2 months after commencement of intervention (intervention group only).
Secondary outcome [12] 392332 0
Depression as measured by the Depression, Anxiety, Stress (DASS-21) depression subscale.
Timepoint [12] 392332 0
At baseline, 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [13] 392333 0
Stress as measured by the Depression, Anxiety, Stress (DASS-21) stress subscale.
Timepoint [13] 392333 0
At baseline, 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [14] 392334 0
Anxiety as measured by the Depression Anxiety Stress (DASS-21) anxiety subscale.
Timepoint [14] 392334 0
At baseline, 2 months, 6 months and 12 months after commencement of intervention.
Secondary outcome [15] 392335 0
Fall-related health literacy using the Falls Health Literacy Scale (FHLS).
Timepoint [15] 392335 0
At baseline, 2 months and 12 months after commencement of intervention.
Secondary outcome [16] 392618 0
Quality of life using the European Quality of Life—5 Dimensions (EQ-5D).
Timepoint [16] 392618 0
At baseline, 6 months and 12 months after commencement of intervention.
Secondary outcome [17] 392619 0
Wellbeing using the COMPAS-W scale.
Timepoint [17] 392619 0
At baseline, 6 months and 12 months after commencement of intervention.
Secondary outcome [18] 392620 0
Adherence to exercise programs using a monthly exercise record
Timepoint [18] 392620 0
Monthly after commencement of exercise program in both intervention groups at 2 months for a maximum of 10 months.
Secondary outcome [19] 392651 0
Usability of the intervention is assessed using the System Usability Scale.
Timepoint [19] 392651 0
At 2 months after commencement of intervention (intervention group only).
Secondary outcome [20] 392652 0
Acceptability of the intervention is assessed using the Attitudes to Falls-Related Interventions Scale.
Timepoint [20] 392652 0
At 2 months after commencement of intervention (intervention group only).
Secondary outcome [21] 392653 0
Health services used using a monthly health services access questionnaire
Timepoint [21] 392653 0
Monthly after commencement of intervention for a maximum of 12 months
Secondary outcome [22] 403167 0
Concerns about falling using the Iconographical Falls Efficacy Scale (IconFES).
Timepoint [22] 403167 0
At 2 months and 6 months after commencement of intervention

Eligibility
Key inclusion criteria
-65 years of age and older

-has substantial concerns about falls or balance, as indicated by:

•Are you concerned about falling or your balance? (self-rated as somewhat to extremely)
•OR “Are you concerned about falling or your balance?” (self-rated as a little bit) and "somewhat to extremely" on any of the following questions (How concerned are you that you might fall when going up/down the stairs? How concerned are you that you might fall when walking on an uneven surface? How concerned are you that you might fall when taking a shower?)
•AND/OR low balance confidence (self-rated as poor or fair) (How do you feel your balance is?)

-able to walk household distances without a walking aid (self-reported)

-living in the community (self-reported)

-English-speaking (self-reported)

-willing and able to give informed consent and comply with the study protocol
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-cognitive impairment (Short Portable Mental Status Questionnaire score <8)
-severe depression or suicidal thoughts (Patient Health Questionnaire-9 score >=20 or scoring 3 on the last question)
-acute psychiatric condition with psychosis (self-reported)
-any medical condition that precludes exercise participation (self-reported)
-progressive neurological condition such as Parkinson’s disease, Multiple Sclerosis, Alzheimer’s disease (self-reported)
-currently participating in a fall prevention program (self-reported)

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 and online. Eligible participants will then proceed to perform the baseline assessment, Following the baseline assessment, participants will be randomly allocated to either the one of the two intervention groups, or the control group. The allocation of the study group will be revealed to the participant over the phone, 2 weeks after completion of their baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to the intervention or control groups will be performed using an independent web-based randomisation service run at NeuRA. 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, Stata, and/or R. Primary and secondary outcomes will be evaluated using mixed models for repeated measures with longitudinal multiple imputation for missing data. Supplementary analyses will compare data for people with higher and lower levels of adherence.

Sample size calculations were conducted to ensure the trial is powered for the primary outcomes. Previous studies have shown effects of Cohen’s f 0.1-0.3 on concerns about falling and 0.1-0.2 on physical activity as results of a CBT program. A conservative sample size calculation with effect size f = 0.1 (~2 points on iconFES concerns about falling scale), alpha = 0.05, power = 0.8, 3 groups, 2 measurements, and r = 0.7 between measurements (estimate based on pilot data, where we observed r = 0.8), suggests a total sample size of 150. Taking into account 35% dropout, we aim to recruit 82 participants per group (N=246).

The main analysis of this study will focus on the effectiveness of the programs on reducing concerns about falling (IconFES) in older people. In this main analysis, the following priority secondary outcomes will be included: habitual walking activity, physical activity, depression, anxiety, stress, and adherence to intervention and exercise programs.

Additionally, the following process evaluation analysis will be done: (i) usability of the intervention at 2 months, and (ii) acceptability of the interventions at 2 months.

In separate papers, the impact of the following additional secondary outcomes of interests on the effectiveness of the programs will be explored: balance confidence, activity avoidance, social activity, falls-related health literacy, well-being, quality of life, exercise self-efficacy, and enjoyment for physical activity. The cost and cost-effectiveness of the interventions will also be analysed using the data from the health access services questionnaires.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/04/2021
Actual
7/06/2021
Date of last participant enrolment
Anticipated
28/02/2023
Actual
16/03/2023
Date of last data collection
Anticipated
30/03/2024
Actual
Sample size
Target
246
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18827 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment hospital [2] 18828 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 29518 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 304961 0
Other Collaborative groups
Name [1] 304961 0
Mindgardens Neuroscience Network
Country [1] 304961 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
139 Barker Street
Randwick, New South Wales, Australia 2031
Country
Australia
Secondary sponsor category [1] 305319 0
Other
Name [1] 305319 0
Black Dog Institute
Address [1] 305319 0
Hospital Rd,
Prince of Wales Hospital,
Randwick NSW 2031
Country [1] 305319 0
Australia
Secondary sponsor category [2] 305473 0
University
Name [2] 305473 0
University of New South Wales
Address [2] 305473 0
High St
Kensington, NSW 2052
Australia
Country [2] 305473 0
Australia
Secondary sponsor category [3] 305474 0
Hospital
Name [3] 305474 0
Prince of Wales Hospital
Address [3] 305474 0
320-346 Barker St, Randwick NSW 2031
Country [3] 305474 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305371 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 305371 0
G71 East Wing Edmund Blacket Building, Prince of Wales Hospital, Randwick NSW 2031
Ethics committee country [1] 305371 0
Australia
Date submitted for ethics approval [1] 305371 0
Approval date [1] 305371 0
24/01/2020
Ethics approval number [1] 305371 0
2019/ETH12840

Summary
Brief summary
The aim of this study is to assess the effectiveness of a novel self-managed cognitive behavioural therapy program on concerns about falling with or without an additional graded balance program versus an online health education program with a focus on general health concerns relevant to older people. The primary outcome (concerns about falling) and secondary outcomes (balance confidence, depression, anxiety, activity avoidance, wellbeing, fall-related health literacy, physical activity, movement intensity, quality of life, exercise self-efficacy and falls) will be measured in the form of a randomised controlled trial. Ongoing exercise participation for both intervention groups beyond the 8-week program will be facilitated through the New South Wales Active and Healthy website to continue with a pandemic-safe exercise program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100150 0
Prof Kim Delbaere
Address 100150 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031 Australia
Country 100150 0
Australia
Phone 100150 0
+61 2 93991066
Fax 100150 0
Email 100150 0
[email protected]
Contact person for public queries
Name 100151 0
Prof Kim Delbaere
Address 100151 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031 Australia
Country 100151 0
Australia
Phone 100151 0
+61 2 93991066
Fax 100151 0
Email 100151 0
[email protected]
Contact person for scientific queries
Name 100152 0
Prof Kim Delbaere
Address 100152 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031 Australia
Country 100152 0
Australia
Phone 100152 0
+61 2 93991066
Fax 100152 0
Email 100152 0
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCognitive behavioural therapy (CBT) with and without exercise to reduce fear of falling in older people living in the community.2023https://dx.doi.org/10.1002/14651858.CD014666.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.