Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001074583
Ethics application status
Approved
Date submitted
14/08/2024
Date registered
5/09/2024
Date last updated
5/09/2024
Date data sharing statement initially provided
5/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinician training models for HeLP (A Healthy Lifestyle program for Pain) to support older people with musculoskeletal conditions and comorbid chronic disease risks
Scientific title
Clinician training models for HeLP (A Healthy Lifestyle program for Pain) to support older people with musculoskeletal conditions and comorbid chronic disease risks
Secondary ID [1] 312753 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 334789 0
Hip pain 334790 0
Knee pain 334791 0
Condition category
Condition code
Musculoskeletal 331351 331351 0 0
Osteoarthritis
Musculoskeletal 331352 331352 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible and consenting physiotherapists will be provided one of two training models to inform a larger-scale implementation strategy for capacity building of community clinicians. Both models will be completed within four weeks of baseline data collection. The intervention is an Individual self-paced training model (approx duration 2 hours). Participants will be provided with access to an online dashboard/folder containing all the training modules. The modules/resources are currently under development for this study. The individual self-paced training model includes:
- Clinician education about HeLP, which will provide clinicians with theoretical knowledge of the relationship between musculoskeletal conditions, pain, falls, and chronic disease risks.
- Behaviour change communication skills training, based on Healthy Conversation Skills
- Audit and feedback of HeLP delivery for clinicians 2-4 weeks post-training
- Resource- HeLP booklet (for patients)
- Resource- Behaviour change skills infographic
- Access to HeLP mentor for six months. The HeLP mentor is a HeLP-trained clinician (physiotherapist or chiropractor) with over 10 years of clinical experience.

A number of strategies will be used to assess/monitor adherence to the intervention (e.g., fidelity checklists, training completion status), see outcomes for further details.
Intervention code [1] 329284 0
Behaviour
Comparator / control treatment
Eligible and consenting physiotherapists will be provided one of two training models to inform a larger-scale implementation strategy for capacity building of community clinicians. Both models will be completed within four weeks of baseline data collection. The comparator is a Group Training Model (approx duration 3.5 hours). It will be delivered online OR face-to-face (not hybrid), depending on the preferences of the participants. The Group Training Model includes:
- Clinician education about HeLP
- Behaviour change communication skills training, Healthy Conversation Skills (Lite)
- Audit and feedback of HeLP delivery for clinicians 2-4 weeks post-training
- Resource- HeLP booklet (for patients)
- Resources- Healthy Conversation Skills (HCS) (SMARTER planner, HCS prompt, HCS self-reflection sheet, HCS summary sheet, list of example HCS questions generated by the group during training.
- Access to HeLP mentor for six months

A number of strategies will be used to assess/monitor adherence to the intervention (e.g., fidelity checklists, training attendance), see outcomes for further details.
Control group
Active

Outcomes
Primary outcome [1] 339107 0
Use
Timepoint [1] 339107 0
4 weeks post-training
Secondary outcome [1] 438581 0
Clinician communication skills
Timepoint [1] 438581 0
Pre-training, immediately post-training, 3-month follow-up
Secondary outcome [2] 438582 0
Confidence
Timepoint [2] 438582 0
Pre-training, immediately post-training, 3-month follow-up
Secondary outcome [3] 438583 0
Importance
Timepoint [3] 438583 0
Pre-training, immediately post-training, 3-month follow-up
Secondary outcome [4] 438584 0
Usefulness
Timepoint [4] 438584 0
Immediately post-training, 3-month follow-up
Secondary outcome [5] 438585 0
Ability (Competence)
Timepoint [5] 438585 0
Pre-training, immediately post-training, 3-month follow-up
Secondary outcome [6] 438586 0
Ability (Competence) and barriers
Timepoint [6] 438586 0
Immediately post-training, 3-month follow-up
Secondary outcome [7] 438587 0
Use
Timepoint [7] 438587 0
Assessed at four weeks post-training
Secondary outcome [8] 438588 0
Self-reported Fidelity (how well clinicians use HeLP principles)
Timepoint [8] 438588 0
Post appointment with client with hip, knee or back pain within four weeks of training
Secondary outcome [9] 438589 0
Fidelity (how well clinicians use) assessed during audit and feedback of HeLP delivery
Timepoint [9] 438589 0
Post appointment with client with hip, knee or back pain within four weeks of training
Secondary outcome [10] 438590 0
Training feedback
Timepoint [10] 438590 0
Immediately post-training
Secondary outcome [11] 438591 0
Acceptability
Timepoint [11] 438591 0
Immediately post-training, 3-month follow-up
Secondary outcome [12] 438592 0
Appropriateness
Timepoint [12] 438592 0
Immediately post-training, 3-month follow-up
Secondary outcome [13] 438593 0
Feasibility
Timepoint [13] 438593 0
Immediately post-training, 3-month follow-up
Secondary outcome [14] 438594 0
Satisfaction
Timepoint [14] 438594 0
3-month follow-up
Secondary outcome [15] 438595 0
Carbon footprinting
Timepoint [15] 438595 0
Immediately post-training, 3-month follow-up

Eligibility
Key inclusion criteria
- Clinicians from public or private physiotherapy services that agree to undertake HeLP training
- Able to participate in clinician training sessions
- Regularly see clients (at least two per week) with musculoskeletal conditions (hip, knee or low back pain).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- No specific exclusion criteria

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary analysis will use logistic regression to compare the ‘Use’ of HeLP with suitable patients in the four-week period following training between the ISP and GT groups. The estimate from this model summarising the intervention effect will be the odds ratio and corresponding 95% confidence interval of ISP vs GT. Secondary outcomes will also be analysed using generalised linear models (GLMs). For each outcome, an appropriate distribution and link function will be selected. We will obtain estimates of the effect of the intervention and 95% confidence intervals by constructing linear contrasts to compare the adjusted mean change (continuous variables) or difference in proportions (dichotomous variables) in outcomes from baseline to each time point between the groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317183 0
Charities/Societies/Foundations
Name [1] 317183 0
HCF Research Foundation
Country [1] 317183 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District Population Health
Address
Country
Australia
Secondary sponsor category [1] 319452 0
University
Name [1] 319452 0
University of Sydney
Address [1] 319452 0
Country [1] 319452 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315927 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 315927 0
Ethics committee country [1] 315927 0
Australia
Date submitted for ethics approval [1] 315927 0
28/06/2024
Approval date [1] 315927 0
22/07/2024
Ethics approval number [1] 315927 0
2024/ETH01214

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

Contacts
Principal investigator
Name 136246 0
Dr Simon Davidson
Address 136246 0
Population Health, Hunter New England Local Health District, Longworth Ave, Wallsend NSW 2287
Country 136246 0
Australia
Phone 136246 0
+61 02 9351 9923
Fax 136246 0
Email 136246 0
[email protected]
Contact person for public queries
Name 136247 0
Simon Davidson
Address 136247 0
Population Health, Hunter New England Local Health District, Longworth Ave, Wallsend NSW 2287
Country 136247 0
Australia
Phone 136247 0
+61 02 9351 9923
Fax 136247 0
Email 136247 0
[email protected]
Contact person for scientific queries
Name 136248 0
Simon Davidson
Address 136248 0
Population Health, Hunter New England Local Health District, Longworth Ave, Wallsend NSW 2287
Country 136248 0
Australia
Phone 136248 0
+61 02 9351 9923
Fax 136248 0
Email 136248 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?
De-identified individual participant data collected during the trial
When will data be available (start and end dates)?
Start- Immediately following publication
End- 5 years following main results publication
Available to whom?
Researchers who provide a methodologically sound proposal that is approved by the Principal Investigator ([email protected])
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by 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.