Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000180617p
Ethics application status
Submitted, not yet approved
Date submitted
1/02/2023
Date registered
21/02/2023
Date last updated
21/02/2023
Date data sharing statement initially provided
21/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact and usability of a digital health intervention designed in the workplace
Scientific title
Efficacy and usability of BodyGuide, a digital health education and exercise intervention, in the workplace
Secondary ID [1] 308878 0
None
Universal Trial Number (UTN)
Trial acronym
BodyGuide
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 328870 0
Condition category
Condition code
Public Health 325864 325864 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BodyGuide’s education and exercise programs are delivered via smart algorithms, based on the user's responses to a series of questions relating to their discomfort. The algorithms also detect risk and encourage users to engage with traditional care where appropriate. BodyGuide programs are 100% self-service, allowing users to access curated, trusted information promoting self-care health literacy.

The intervention starts an introductory webinar which outlines the BodyGuide program and how users can participate. The webinar is a live event held online to inform virtual audience (i.e. individual users that have signed up) about a BodyGuide. The webinar's purpose is instructional and educational in a one-to-many format as opposed to a video conference. In these webinars, the participants are made aware of the program, how to access to their individual BodyGuide asynchronous exercise programs and support material (including access to the book 'I'm Sick of Being Sore' which they can refer to at their discretion). As well as access to their individual online BodyGuide exercise program, participants will also be offered ongoing support through telehealth coaching in groups or as individuals to discuss any aspect of the intervention - group or individual participation in these sessions is voluntary and at the choice of the individual.

The BodyGuide intervention includes:
a) Physical or informational materials: Participants will have access to I’m Sick of Being Sore paperback book, as well as massage balls.
b) The intervention includes a program of exercise and self-massage techniques which are guided through the online webinars.
c) The only intervention delivered will be online webinars, delivered by a qualified Myotherapist.
d) The mode of delivery is digital/Online
e) Participants will have access to 28 sessions, to be consumed at their own discretion, over a duration no longer than 3 months.
f) The intervention occurs in a location of the participants choice (likely the place/s they typically exercise).
g) Participants will be enrolled in an online newsletter promoting adherence during the trial to help encourage, assess and monitor adherence or fidelity to the intervention.

As an evidence-based foundation, we will conduct a research study that will:
• Develop an effective framework for evaluating patient outcomes in combination with assessing the usability of BodyGuide as a digital health solution
• Systematically validate BodyGuide for efficacy (patient outcomes) and usability
• Validate asynchronous support coupled with group learning (through webinars, telehealth and coaching)
• Identify user defined barriers/facilitators to the digital health BodyGuide program
Intervention code [1] 325321 0
Treatment: Other
Intervention code [2] 325322 0
Treatment: Devices
Comparator / control treatment
No control group
We are proposing an interventional exploratory study with employees from organisations in Australia. The applied methods will comprise access to the BodyGuide program and qualitative interviews based on an assessment framework to validate the efficacy and useability of the platform. Qualitative approaches of empirical social and ethnological research will be used: a survey with participants will assess both useability and patient outcomes using the various available approaches within the platform (from basic access to asynchronous support).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333692 0
Primary outcome is a perceived assessment of physical discomfort, along the lines of:
- In the past month, how often have you experienced pain or discomfort (excluding menstrual pain)
- In the past month, how would you rate the severity of your pain or discomfort on average.
- In the past month, how would you rate your pain or discomfort at its worst
- In the past month, do you feel that your discomfort has limited some of your everyday movements (bending, twisting, lifting, squatting)
- In the past month, have you felt that your pain or discomfort is stopping you from being more active/exercising
In a combination of 1-10 and subjective responses (never, sometimes, often, always).

Following a literature review, it was determined that no existing evaluation tools were appropriate. As such, a new survey tool has been developed for this project.
Timepoint [1] 333692 0
There are 3 surveys delivered. One is pre-intervention, one is 4 weeks after first commencement of intervention, the final occurs 8 weeks after 1st intervention.
Secondary outcome [1] 417960 0
system useability (measuring usability in context of a preventative digital coaching platform) will be assessed using a post study usability and acceptability questionnaire.. Following a literature review, it was determined that no existing tools were appropriate. As such, a new survey tool has been developed for this project.
Timepoint [1] 417960 0
There are 2 surveys delivered for this outcome. One is 4 weeks after first commencement of intervention, the final occurs 8 weeks after 1st intervention.
Secondary outcome [2] 418229 0
KINESIOPHOBIA i.e .,In the past month, have you found yourself avoiding certain movements due to a fear of making pain or discomfort worse?

Following a literature review, it was determined that no existing tools were appropriate. As such, a new survey tool has been developed for this project.
Timepoint [2] 418229 0
There are 3 surveys delivered. One is pre-intervention, one is 4 weeks after first commencement of intervention, the final occurs 8 weeks after 1st intervention.
Secondary outcome [3] 418231 0
SOCIAL IMPACT i.e.,
In the past month, how much has your pain or discomfort interfered with you taking part in recreational, social, family activities?

Following a literature review, it was determined that no existing tools were appropriate. As such, a new survey tool has been developed for this project.
Timepoint [3] 418231 0
There are 3 surveys delivered. One is pre-intervention, one is 4 weeks after first commencement of intervention, the final occurs 8 weeks after 1st intervention.
Secondary outcome [4] 418232 0
HEALTH LITERACY i.e.,
- How confident do you feel that you understand the cause of your pain or discomfort
- How confident are you in self-managing pain or discomfort using movement or self-treatment (excluding medication)
- Has your understanding of your pain or discomfort increased since using BodyGuide Platform

Following a literature review, it was determined that no existing tools were appropriate. As such, a new survey tool has been developed for this project.
Timepoint [4] 418232 0
There are 3 surveys delivered. One is pre-intervention, one is 4 weeks after first commencement of intervention, the final occurs 8 weeks after 1st intervention.
Secondary outcome [5] 418614 0
User defined barriers to the digital health BodyGuide program assessed through a survey specifically designed for this study.

How do you rate the priorities of these following barriers in the implementation of digital health solutions
(Technical) errors and problems with digital health solutions
No technical equipment and accessibility
Lack of personal and physical contact
Lack of information about the technology
Stress and anxiety triggered by technology
No added benefit compared to healthcare that is not technology-enabled
Problems and issues with the use of digital health solutions

Are there any other barriers that should be prioritised (top three as free text)
Timepoint [5] 418614 0
There are 2 surveys delivered. One is pre-intervention, one occurs 8 weeks after 1st intervention.
Secondary outcome [6] 418615 0
User defined facilitators to the digital health BodyGuide program assessed through a survey specifically designed for this study.

How do you rate the priorities of these following facilitators in the implementation of digital health solutions (Likert scale 1-5):
Time and cost savings
More flexibility in care and everyday planning
Versatile and practical functions of digital health solutions
Design layout and ease of use of digital health solutions
Positive influence on the behaviour of patients
Sufficient information about digital health solutions and their use

Are there any other facilitators that should be prioritised (top three as free text)
Timepoint [6] 418615 0
There are 2 surveys delivered. One is pre-intervention, one occurs 8 weeks after 1st intervention.

Eligibility
Key inclusion criteria
Study population
Workforce participants willing to use BodyGuide – participants will be contacted by the researchers via e-or telephone.
Inclusion/Exclusion Criteria
Inclusion:
Only participants fulfilling all inclusion criteria and for whom no exclusion criteria apply will be included. Each participant will receive an individual study identification number. This identification number will be used to anonymize the personal data obtained for data analysis.
The following criteria must be fulfilled in order to participate in the study:
• Working full or part time.
• Employment/Work is carried out in Australia
• Willingness to participate in the study and signed written consent of the participant
• Persons aged >=18 and able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion:
Persons living in a country other than Australia and not working.

Study design
Purpose of the study
Treatment
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
Not yet recruiting
Date of first participant enrolment
Anticipated
17/04/2023
Actual
Date of last participant enrolment
Anticipated
1/09/2023
Actual
Date of last data collection
Anticipated
29/09/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313094 0
University
Name [1] 313094 0
La Trobe University
Country [1] 313094 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Rd & Kingsbury Drive
Bundoora
Victoria
3086
Country
Australia
Secondary sponsor category [1] 314786 0
None
Name [1] 314786 0
Address [1] 314786 0
Country [1] 314786 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312339 0
La Trobe University HREC
Ethics committee address [1] 312339 0
La Trobe University
Plenty Road
Bundoora
Melbourne
Victoria 3086
Ethics committee country [1] 312339 0
Australia
Date submitted for ethics approval [1] 312339 0
10/02/2023
Approval date [1] 312339 0
Ethics approval number [1] 312339 0

Summary
Brief summary
BodyGuide’s education and exercise programs are delivered via smart algorithms, based on the user's responses to a series of questions relating to their discomfort. The algorithms also detect risk and encourage users to engage with traditional care where appropriate. BodyGuide programs are 100% self-service, allowing users to access curated, trusted information promoting self-care health literacy.
As an evidence-based foundation, we will conduct a research study that will:
• Develop an effective framework for evaluating patient outcomes in combination with assessing the usability of BodyGuide as a digital health solution
• Systematically validate BodyGuide for efficacy (patient outcomes) and usability
• Validate asynchronous support coupled with group learning (through webinars, telehealth and coaching)
• Identify user defined barriers/facilitators to the digital health BodyGuide program

Aims
Objective 1: Create an appropriate framework to measure the efficacy and usability of BodyGuide
Objective 2: Systematically validate the BodyGuide App for efficacy (based on patient outcomes) and usability – this is the basic BodyGuide model with no telehealth or coaching
Objective 3: Assess the impact of adding asynchronous support coupled with group learning (through webinars, telehealth and coaching) on patient outcomes
Objective 4: Identify user defined barriers/facilitators to the digital health BodyGuide program


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124310 0
Prof James Boyd
Address 124310 0
La Trobe University
Plenty Rd & Kingsbury Drive,
Bundoora
Victoria
3086
Country 124310 0
Australia
Phone 124310 0
+61 0401103701
Fax 124310 0
Email 124310 0
james.boyd@latrobe.edu.au
Contact person for public queries
Name 124311 0
Prof James Boyd
Address 124311 0
La Trobe University
Plenty Rd & Kingsbury Drive,
Bundoora
Victoria
3086
Country 124311 0
Australia
Phone 124311 0
+61 0401103701
Fax 124311 0
Email 124311 0
james.boyd@latrobe.edu.au
Contact person for scientific queries
Name 124312 0
Prof James Boyd
Address 124312 0
La Trobe University
Plenty Rd & Kingsbury Drive,
Bundoora
Victoria
3086
Country 124312 0
Australia
Phone 124312 0
+61 0401103701
Fax 124312 0
Email 124312 0
james.boyd@latrobe.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
Privacy requirements.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18191Ethical approval    Will be Uploaded on approval.
18192Informed consent form    Will be Uploaded on ethics approval.
18193Study protocol    Will be Uploaded on ethics approval.



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.