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Trial registered on ANZCTR


Registration number
ACTRN12623001025628p
Ethics application status
Submitted, not yet approved
Date submitted
19/07/2023
Date registered
21/09/2023
Date last updated
8/09/2024
Date data sharing statement initially provided
21/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of the 'LeapForward' program on return-to-work and injury-related outcomes: a pragmatic randomised controlled trial
Scientific title
The effectiveness of an online rehabilitation program 'LeapForward' for improving return-to-work and injury-related outcomes in people on an active workers compensation claim: a pragmatic randomised controlled trial.
Secondary ID [1] 309636 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Return-to-work status 329968 0
Work-related physical injury 329969 0
Work-related psychological injury 329970 0
Psychological distress 331353 0
Condition category
Condition code
Musculoskeletal 326875 326875 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 326877 326877 0 0
Occupational therapy
Mental Health 326878 326878 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The “LeapForward Program” is a 6-week online program that integrates evidence-based strategies from the Lifestyle Medicine and Positive Psychology literature. Underpinning the intervention is numerous behaviour change techniques to target determinants of lifestyle behaviours, including goal-setting, problem-solving, goal-review, self-monitoring, feedback, social support and education with credible sources.
Participants access the program via a smart device which consisted of the following components: ‘Lucy’, an AI health coach; the LeapForward website including daily educational video content; a weekly telehealth call with an allied health coach; and a LeapForward workbook.
Each day participants receive a text and/or email prompting them to log in and complete the daily content. The educational content which is delivered via short ~5-minute videos, and discussed by Lucy and the health coach is broken down into the following topics:
Week 1: Foundations
Introduction, short-term goal setting, why movement is medicine, why work is good for wellbeing, your brain and pain.

Week 2 and 3: My Mind
Power of your mind, mindfulness, self-esteem, resilience, coping skills, gratitude, stress, power of thoughts, cognitive re-framing, unhelpful thinking styles, diffusion strategies, choosing different responses vs reactions.

Week 4: My Body
Finding things you enjoy, movement is medicine, food and mood, eating for energy, identifying uppers and downers.

Week 5 and 6: My Life
Coping with stress, importance of meaningful connections, understanding depression, recognising what you can control, reflecting on goals.

The weekly telehealth calls are scheduled via the website and involve a 30-minute phone discussion with an allied health professional. These calls are designed as an opportunity to assess and provide any additional support in order for participants to fully engage, understand and apply the concepts and exercises from the program into their day-to-day lives.

The workbook compliments the themes (My Foundations, My Mind, My Body, My Life) and learning concepts discussed in each video. The workbook follows the same content structure as the videos, and provides space for written exercises (e.g., reflections, journalling).
Lucy is a rules-based virtual health coach (i.e., a range of answers are presented for the user to select from when answering questions), created and hosted using Clevertar’s AI chatbot software (Clevertar Services Pty Ltd, Adelaide, Australia). Lucy performs three key roles: (1) guides participants through an introductory session involving baseline measures and program overview (~10 minutes); (2) guides users through a daily check-in regarding their mood and goal progress (~5 minutes); and (3) prompts the daily educational video and engages in a brief discussion to ensure comprehension of video concepts and then prompts goal setting based on the daily content (~5 minutes). Participants are required to create a user account to access the program.
Total time:
Engagement in each of the program components is estimated to take 15-20 minutes per day of content and is designed to be completed 5 days per week, with a 30-minute call each week. This equates to approximately 2 hours and 10 minutes per week of engagement with the program.
Since the program is designed to target health lifestyle behaviours, there may be additional time spent working on goals such as going for a daily walk, doing 3 minutes of mindfulness etc. Please note that the time spent on these activities would be additional to the proposed time commitment calculated above. Since the activities chosen and time invested would vary greatly between users, we estimate that approximately 1-2 hours per week may be spent working on healthy lifestyle behaviours and goals.
Adherence:
Website use and engagement with Lucy is monitored via web-analytics. Completion of the workbook is not assessed and is not compulsory, however, it is strongly recommended and is frequently referenced in videos and by Lucy. Engagement in telehealth calls is recorded by the allied health coach. These calls are part of the program but are not compulsory.
Intervention code [1] 326067 0
Lifestyle
Intervention code [2] 326068 0
Rehabilitation
Comparator / control treatment
Treatment-as-usual.
The control group will continue with standard claims management (e.g., treatment as usual) including referral to allied health and other relevant medical treatment.
The control group will be blinded to their allocation to a control condition and therefore will not be aware that the study is comparing their outcomes to those who participate in the LeapForward program. Both groups receive information that outlines the study is interested in collecting mental health and wellbeing and return-to-work outcomes which should minimise any potential Hawthorne effect bias. Both groups complete identical outcomes at all time points. At the end of the study, the LeapForward program will be offered to participants in the control group upon study completion if deemed appropriate by EML
Control group
Active

Outcomes
Primary outcome [1] 334719 0
Return-to-work (RTW) status assessed per the categories used within New South Wales: 1) not working/has current work capacity, 2) not working/ no current work capacity, 3) working different employer/current work capacity, 4) working different employer/full work capacity, 5) working same employer/current work capacity, 6) working same employer/full work capacity.
RTW status is determined by the treating medical doctor.
Timepoint [1] 334719 0
8 months post-baseline.
Primary outcome [2] 335975 0
For participants on a psychological injury claim: changes in Patient Health Questionnaire (PHQ-12)
Timepoint [2] 335975 0
Baseline and immediately post-intervention (8-weeks).

This will also be measured at both follow-up time points:
5-months post baseline.
8-months post baseline.
Primary outcome [3] 335976 0
For participants on a physical injury claim: changes in musculoskeletal pain as measured by the Orebro Musculoskeletal Pain Questionnaire (OMPQ)
Timepoint [3] 335976 0
Baseline and immediately post-intervention (8-weeks).

This will also be measured at both follow-up time points:
5-months post baseline.
8-months post baseline.
Secondary outcome [1] 421863 0
Psychological distress (Kessler-10)
Timepoint [1] 421863 0
Baseline and immediately post-intervention (8-weeks).

This will also be measured at both follow-up time points:
5-months post baseline.
8-months post baseline.
Secondary outcome [2] 421864 0
Mental well-being (World Health Organisation Wellbeing Questionnaire; WHO-5)
Timepoint [2] 421864 0
Baseline and immediately post-intervention (8-weeks).

This will also be measured at both follow-up time points:
5-months post baseline.
8-months post baseline.
Secondary outcome [3] 421865 0
Claim cost (i.e., assessed as total workers compensation claim cost as reported by EML Insurance).
Timepoint [3] 421865 0
Baseline and final follow up time point: 8-months post baseline.
Secondary outcome [4] 426323 0
Self-efficacy (General Self-Efficacy Scale)
.
Timepoint [4] 426323 0
Baseline and immediately post-intervention (8-weeks).

This will also be measured at both follow-up time points:
5-months post baseline.
8-months post baseline.
Secondary outcome [5] 426324 0
Program engagement (uptake and drop out)
Uptake will be calculated as the % of people who signed up for the program from the total number of people the program was offered to via email from EMLs database. This will be done through audit of study records.

Drop out will be calculated as the % of participants who ceased participation after signing up for the program. This will be calculated through audit of study records. Drop out will be reported in the following categories:
1) Dropped out after signing up but before commencing program
2) Dropped out during program (reasons will be listed if obtained).
Timepoint [5] 426324 0
Upon conclusion of the study
Secondary outcome [6] 426325 0
Program engagement (reported as days completed and telehealth sessions completed)

Engagement with each day of the program is assessed and reported by web-analytics. For a participant to 'complete the day' they are required to:
1) complete their check in with Lucy
2) watch the video content
3) briefly discuss the key take away from the video, this may include setting a goal related to the content

The number of telehealth coaching sessions completed will be reported via the allied health coach and logged into the participants web user profile and reported via web-analytics with the above data.
Timepoint [6] 426325 0
Immediately post intervention (8-weeks post baseline).
Secondary outcome [7] 426326 0
Program acceptability (user feedback captured with a 7-item study-specific survey)
1) overall how did you find the program?
2) what parts of the program did you like most?
3) what parts of the program did you like least?
4) since doing the program is there one thing that you have noticed that has really changed in your life?
5) How would you describe how you feel about things compared to when you started the program?
6) could you suggest any changes to the program that would make it more useful to people experiencing similar problems to yourself?
7) how likely is it that you would recommend LeapForward to a friend of colleague with similar issues? (rated on a 0-10 Likert scale)
Timepoint [7] 426326 0
Immediately post intervention (8-weeks post baseline).

Eligibility
Key inclusion criteria
Potential participant on a psychological injury claim.
1. From 7 days post claim to 20 weeks post claim.
2. Not currently at work.

Potential participant on a physical injury claim
1. From 3 weeks post claim to 20 weeks post claim.
2. Not currently at work.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A current post-traumatic stress disorder diagnosis as per EML Insurance records.
2. Claimants on a Loss Prevention and Recovery premium

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)
Allocation was concealed. Randomised sequence for invitations to the study was provided by the research team to EML who invite participants to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary and secondary outcomes will be summarised for each group depending on the measurement scale and data distribution (frequencies, means, SDs, medians, IQRs, 95% CIs). To assess the effectiveness of LeapForward on RTW status at all time points, differences between groups will be tested using a Generalized Linear Model (GLM) with random effects. The fixed factors are time, group, and time by group interaction and participant as a random factor. Participant baseline characteristics will be compared between groups, and analyses adjusted for any significant differences. Statistical significance will be considered at p < .05 and post-hoc adjustment will be applied for multiple comparisons. Missing data will be handled using multiple imputation. Analyses will be conducted using an intention-to-treat approach. No interim analyses will be performed.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Due to app development and consequent delays/changes to the product, the recruitment for the RCT was never commenced.
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
6/05/2024
Actual
Date of last data collection
Anticipated
10/01/2025
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313837 0
Commercial sector/Industry
Name [1] 313837 0
LeapForward
Country [1] 313837 0
Australia
Funding source category [2] 313838 0
Commercial sector/Industry
Name [2] 313838 0
EML Insurance
Country [2] 313838 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
LeapForward
Address
International Towers Sydney, Level 27, Tower 1/100 Barangaroo Ave, Barangaroo NSW 2000
Country
Australia
Secondary sponsor category [1] 315657 0
Commercial sector/Industry
Name [1] 315657 0
EML Insurance
Address [1] 315657 0
GPO Box 4143, Sydney NSW 2001
Country [1] 315657 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312979 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 312979 0
Ethics committee country [1] 312979 0
Australia
Date submitted for ethics approval [1] 312979 0
19/05/2023
Approval date [1] 312979 0
Ethics approval number [1] 312979 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126566 0
Dr Jacinta Brinsley
Address 126566 0
University of South Australia, Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country 126566 0
Australia
Phone 126566 0
+61 439769123
Fax 126566 0
Email 126566 0
[email protected]
Contact person for public queries
Name 126567 0
Jacinta Brinsley
Address 126567 0
University of South Australia, Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country 126567 0
Australia
Phone 126567 0
+61 439769123
Fax 126567 0
Email 126567 0
[email protected]
Contact person for scientific queries
Name 126568 0
Jacinta Brinsley
Address 126568 0
University of South Australia, Corner of North Terrace and, Frome Rd, Adelaide SA 5001
Country 126568 0
Australia
Phone 126568 0
+61 439769123
Fax 126568 0
Email 126568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Unidentified data:
Gender, age bracket, type of injury (physical or psychological), RTW Status, K10, WHO-5, GSE
When will data be available (start and end dates)?
Immediately following publication - no end date.
Available to whom?
Requests for data will be handled on a case-by-case basis at the discretion of the Principal Investigator, EML Insurance and LeapForward (study sponsors).
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approval: contact principal investigator ([email protected])


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.