Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000551695
Ethics application status
Approved
Date submitted
22/03/2023
Date registered
23/05/2023
Date last updated
30/06/2024
Date data sharing statement initially provided
23/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the scope and efficacy of a digitised, innovative psychosocial recovery program for individuals post- Motor Vehicle Accident (MVA)
Scientific title
Evaluation of the scope and efficacy of a digitised, innovative psychosocial recovery program targeting disability, distress and self-efficacy in adults post- Motor Vehicle Accident (MVA)
Secondary ID [1] 309263 0
NIL
Universal Trial Number (UTN)
Trial acronym
LeapForward
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft-Tissue Injuries (STI) 329419 0
Orthopaedic Injuries 329420 0
Condition category
Condition code
Injuries and Accidents 326366 326366 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
LeapForward is a 6-week app-based program designed to help a person recover from injury or illness by addressing psychosocial barriers that impact recovery. It is a digitised 6-week program that harnesses psychology, technology and coaching to support people in getting back to health, life and work. The digital platform is also supported by personalised specialist telecoaching and workbook activities which have been designed specifically for this study. It is a complementary program to existing healthcare and rehabilitation interventions.

The program is 15 minutes a day for 6 weeks.
LeapForward is delivered via a smart-device optimised webapp
It consists of daily building blocks:
• Interactive coaching with our virtual coach, Lucy
• Daily bite-sized videos from our team
• An interactive workbook with self-reflection and goal-setting activities
Participants are supported by weekly sessions with the digital Health Coach, called Lucy.
The six modules are grouped into 4 content areas: My Foundations (5 modules) and then the three ‘pillars’: My Mind (10 modules), My Body (5 modules), My Life (10 modules).
· Each module takes ~15 minutes to complete and consists of:
- Conversational psycho-education with digitised Health Coach – Lucy;
- Watching of a health-information video (related to the Topic of the Day);
- Completion of self-reflection and goal-setting activities via a workbook.
· Lucy supports each module and guides the Participant on all particulars.
Intervention code [1] 325700 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334219 0
Disability: The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a tool used to evaluate pre- and post-operative disability. WHODAS 2.0 lists 12 activities of daily living and asks individuals to rate the level of difficulty experienced for a task during the previous 30 days (Organisation, 2016). A five-point rating scale (none=0, mild=1, moderate=2, severe=3, extreme/cannot do=4) is used; the scores on each activity are combined into a final score out of 60 which is then expressed as a percentage. Higher scores reflect greater disability and a score of 25% or greater is defined as disability.
Timepoint [1] 334219 0
6-weeks post-commencement of the intervention.
Primary outcome [2] 334457 0
Distress: The Kessler 10 (K10) is a commonly used screening scale for non-specific psychological distress validated for use in Australia (Furukawa et al., 2003). The K10 is a 10-item scale. Scores on the K10 range from 10 to 50, and a score of 30 or more indicates severe level of distress.
Timepoint [2] 334457 0
6 weeks post-commencement of the intervention.
Primary outcome [3] 334458 0
Self-Efficacy: The General Self-Efficacy Scale (GSEQ) assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events (Schwarzer, 1995). The GSE is a 10-item scale the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Timepoint [3] 334458 0
6 weeks post commencement of the intervention
Secondary outcome [1] 419876 0
Return-to-work rates; change in employment status reported in-app at baseline and post-intervention will be used to compare to average aggregated data publicly available at (for example):
CTP Insurer Claims Experience and Customer Feedback Comparison - SIRA (nsw.gov.au)
Timepoint [1] 419876 0
6-12 weeks post-commencement of intervention
Secondary outcome [2] 420777 0
Feasibility, Engagement and Usability:

Objective engagement (usage) metrics: obtained through the program’s automatic recording – time spent, number of logins, modules, interaction and attrition.
Timepoint [2] 420777 0
6 to 12 weeks post-commencement of intervention
Secondary outcome [3] 420778 0
Acceptability and usability: 26-item acceptability and usability questionnaire (comprising adapted items from the System Usability Scale; Post Study System Usability Questionnaire; Technology Assessment Model Measurement Scales; and Usefulness, Satisfaction, and Ease questionnaire), and this blended tool has been used successfully in previous research (Ben-Zeev et al., 2014, Deady et al., 2018). Participants were asked to rate their agreement with a series of statements about the intervention.
Timepoint [3] 420778 0
6 to 12 weeks post-commencement of intervention
Secondary outcome [4] 420779 0
Qualitative Evaluation: AFTER completing the intervention program participants will be invited within the App to take part in an interview evaluating the program. a researcher from the University of Sydney will contact interested participants via email or phone to arrange a time to meet. After informed consent semi-structured interview will conduct a content analysis to ensure the features and design are suitable for this target group. This will be conducted via password entry Zoom and will be audio recorded after consent.
Timepoint [4] 420779 0
6-12 weeks post commencement of intervention

Eligibility
Key inclusion criteria
Inclusion Criteria
• Participants of the program must be 18 years and over.
• Open & accepted claim with NRMA Comprehensive Third Party (CTP) insurance (NSW).
• Soft Tissue Injury; Orthopaedic injuries.
• Participants must have access to either a smart phone, tablet or computer and have sufficient independent IT literacy.
• Sufficient English language literacy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• No PTSD
• No other diagnosable psych condition related to MVA
• No Traumatic Brain injuries or post-concussion syndrome

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/09/2023
Actual
20/09/2023
Date of last participant enrolment
Anticipated
7/10/2024
Actual
Date of last data collection
Anticipated
10/12/2024
Actual
Sample size
Target
100
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313456 0
Commercial sector/Industry
Name [1] 313456 0
IAG
Country [1] 313456 0
Australia
Funding source category [2] 313459 0
Commercial sector/Industry
Name [2] 313459 0
LeapForward
Country [2] 313459 0
Australia
Funding source category [3] 313460 0
Other Collaborative groups
Name [3] 313460 0
DIGITAL HEALTH CRC LIMITED (DHCRC)
Country [3] 313460 0
Australia
Funding source category [4] 313461 0
University
Name [4] 313461 0
The University of Sydney
Country [4] 313461 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Level 5, Professor Marie Bashir Centre, 67-73 Missenden Road, Camperdown, NSW 2050,

Country
Australia
Secondary sponsor category [1] 315230 0
None
Name [1] 315230 0
Address [1] 315230 0
Country [1] 315230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312656 0
University of Sydney HREC
Ethics committee address [1] 312656 0
Ethics committee country [1] 312656 0
Australia
Date submitted for ethics approval [1] 312656 0
06/03/2023
Approval date [1] 312656 0
26/06/2023
Ethics approval number [1] 312656 0

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

Contacts
Principal investigator
Name 125446 0
Prof Nick Glozier
Address 125446 0
Professor Nick Glozier: Level 5, Professor Marie Bashir Centre, 67-73 Missenden Road, Camperdown, NSW 2050, Brain and Mind Centre, University of Sydney, Sydney, Australia.
Country 125446 0
Australia
Phone 125446 0
+61 2 9515 1596
Fax 125446 0
Email 125446 0
[email protected]
Contact person for public queries
Name 125447 0
Elizabeth Stratton
Address 125447 0
Level 5, Professor Marie Bashir Centre, 67-73 Missenden Road, Camperdown, NSW 2050, Brain and Mind Centre, University of Sydney, Sydney, Australia.
Country 125447 0
Australia
Phone 125447 0
+61 295151439
Fax 125447 0
Email 125447 0
[email protected]
Contact person for scientific queries
Name 125448 0
Elizabeth Stratton
Address 125448 0
Level 5, Professor Marie Bashir Centre, 67-73 Missenden Road, Camperdown, NSW 2050, Brain and Mind Centre, University of Sydney, Sydney, Australia.
Country 125448 0
Australia
Phone 125448 0
+61 295151439
Fax 125448 0
Email 125448 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
participant data will be protected by the insurance agency


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.