Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000139673
Ethics application status
Approved
Date submitted
28/11/2022
Date registered
9/02/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
9/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
HEalth literacy in Low back Pain – the HELP! media intervention study.
Scientific title
HEalth literacy in Low back Pain – the HELP! media intervention study: A stepped wedge cluster randomised trial examining the effect of a media intervention on beliefs about back pain.
Secondary ID [1] 307908 0
None
Universal Trial Number (UTN)
Trial acronym
HELP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low Back Pain 327555 0
Condition category
Condition code
Musculoskeletal 324650 324650 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention consists of two thirty-second videos presenting key messages about back pain management, informed by back pain guidelines, and reviewed by leading experts and clinicians in the field of back pain. The messages include information on the natural prognosis of LBP, the nature of LBP (e.g., pain does not equal harm), advice to stay active, and recommendations for referrals and medications.

The intervention videos will be played on television screens in participating General Practitioner’s waiting rooms. Videos will be played 5 times per hour during the GP clinic’s usual consulting days and times. The frequency is to ensure adequate exposure to the educational video while patients wait for their appointments.

Each step is a month in duration. All clusters will commence the study and progress through each of the 6 steps concurrently. The initial step is the control step where the intervention videos are not displayed at any GP clinic across all clusters. For each subsequent step, 1 cluster will be randomly allocated to the intervention while the other clusters remain in the control period. Subsequently, the addition of one cluster to the intervention at each step will occur until all 5 study clusters are provided with the intervention in the final step. The video will cease playing at all GP clinics once the final step is complete.
Intervention code [1] 324372 0
Behaviour
Comparator / control treatment
The control will have no low back pain educational video played in the participating GP waiting rooms.
Control group
Active

Outcomes
Primary outcome [1] 332467 0
Beliefs about Back Pain using the Back Pain Beliefs Questionnaire
Timepoint [1] 332467 0
The Back Pain Beliefs Questionnaire will be collected while the participant attends the GP practice at a single timepoint/participant interaction after the intervention video has been viewed. There is no restriction on the timing of data collection relative to the intervention.
Secondary outcome [1] 413642 0
Secondary outcomes at the participant level include attitudes about back pain using the 20-item Back Pain Attitudes Questionnaire.
Timepoint [1] 413642 0
The 20-item Back Pain Attitudes Questionnaire will be collected after the participant has viewed the intervention video while attending the GP clinic. There will be no restrictions on the duration of time between viewing the intervention video and completing the online questionnaire.
Secondary outcome [2] 418341 0
Secondary outcomes for the GP-level data will include count-based data on the prescription of medications, referrals for diagnostic imaging, specialist care, and to allied health practitioners. Data will be collected during the usual course of GP care and updated on their data system.
Timepoint [2] 418341 0
The GP count-based data will be collected using the GP data capture software over a 12-month period (3 months prior to, during, and 3 months following the intervention period). Data will be extracted at a single time point and analysed as the pre, mid, and post intervention GP data.

Eligibility
Key inclusion criteria
GP clinic inclusion criteria:
- Tonic Health Media subscribers
- Practice contains 4 or more General Practitioners

Participant Inclusion Criteria:
- Age 18 or older
- Any underlying medical condition
- Attending GP for a new episode of care for any health condition as indicated on the screening survey
- Willing to complete online surveys
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
GP clinic exclusion criteria:
- Practice does not subscribe to or broadcast Tonic Health Media public health messages to patients in waiting room

Participant exclusion criteria:
- Unable to understand English written language
- Not a patient of the practice
- Prior completion of the study surveys as indicated by the screening survey

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)
Group allocation will not be concealed from either the participating GP clinic or participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will take place at the level of general practices (clusters) rather than at the patient level. Stratified allocation of participating 30 GP clinics will be according to which Primary Health Networks they belong to.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
This is a stepped wedge trial with a cross sectional design and therefore participants will be blinded to the nature and content of the intervention if completing the survey in control clinics/periods.

GP clinics will be randomly allocated to 1 of 5 study clusters. All 5 study clusters will commence the study simultaneously and will progress through 6 steps – a new cluster being randomly selected to receive the intervention at each step. Participant data will be collected in the first 3 weeks of each step. Data from participants will be collected at one time-point only during the 6-month participant study period. Steps will have the time duration of 1 month.

Participation in the study may occur during either the control period (study video is not being played in waiting rooms) or the intervention period (study video is being played in waiting rooms). No repeated measures will be taken.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be analysed by an experienced biostatistician blinded to group status. All analyses will be based on the intention-to-treat principle. The primary analysis will include between-group differences on the Back Beliefs Questionnaire at the end of data collection and will be analysed using a linear mixed-effects model adjusting for baseline score. Multiple imputation analyses are performed if there are more than 5% missing values in the primary outcome. Both complete case data and multiple imputed data will be analysed and compared. Data will be summarised and presented as mean, standard deviation (symmetric normal data), median, interquartile range (skewed data or ordinal data), proportions and odds ratios with 95% confidence intervals. Organisational count-based GP data will be compared between the control and intervention periods within clusters at the individual level using a generalised linear mixed effect model with Poisson link function. The generalised mixed effect model can appropriately handle the intra-cluster correlation by allowing a random cluster effect in addition to the required between-groups fixed effects. Over-dispersion in the Poisson model will be tested using Wald’s test or Likelihood Ratio test (LRT). If this formal test indicates, over-dispersion, a negative binomial link function will be used in the generalised mixed model. Statistical significance will be defined as P<0.05 on the basis of a two-sided test. The statistical analysis will be performed in SAS V9.3.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
10/03/2025
Actual
Sample size
Target
1410
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312183 0
Government body
Name [1] 312183 0
NHMRC Investigator grant
Country [1] 312183 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Camperdown
NSW 2006
Country
Australia
Secondary sponsor category [1] 314369 0
None
Name [1] 314369 0
NA
Address [1] 314369 0
NA
Country [1] 314369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311570 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 311570 0
Ethics committee country [1] 311570 0
Australia
Date submitted for ethics approval [1] 311570 0
30/11/2022
Approval date [1] 311570 0
01/03/2023
Ethics approval number [1] 311570 0
2022/ETH01928

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

Contacts
Principal investigator
Name 121558 0
Prof Manuela Ferreira
Address 121558 0
Faculty of Medicine and Health, School of Health Sciences
Level 10, Kolling Building,
Royal North Shore Hospital,
10 Westbourne Street,
St Leonards, NSW 2065
Country 121558 0
Australia
Phone 121558 0
+61 2 9463 1987
Fax 121558 0
Email 121558 0
Manuela.ferreira@sydney.edu.au
Contact person for public queries
Name 121559 0
Manuela Ferreira
Address 121559 0
Faculty of Medicine and Health, School of Health Sciences
Level 10, Kolling Building,
Royal North Shore Hospital,
10 Westbourne Street,
St Leonards, NSW 2065
Country 121559 0
Australia
Phone 121559 0
+61 2 9463 1987
Fax 121559 0
Email 121559 0
Manuela.ferreira@sydney.edu.au
Contact person for scientific queries
Name 121560 0
Manuela Ferreira
Address 121560 0
Faculty of Medicine and Health, School of Health Sciences
Level 10, Kolling Building,
Royal North Shore Hospital,
10 Westbourne Street,
St Leonards, NSW 2065
Country 121560 0
Australia
Phone 121560 0
+61 2 9463 1987
Fax 121560 0
Email 121560 0
Manuela.ferreira@sydney.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
All participant data collected by the study will be de-identified and analysed according to group i.e. control or intervention time of study interaction.

GP data will be collected and reported as de-identified as total numbers of patients attending for a LBP review, total numbers of referrals for medical imaging or specialist review and total numbers prescribed medication.

No individual participant data will be publicly available to protect confidentially and privacy of individual participants.


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.