Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000636853
Ethics application status
Approved
Date submitted
6/04/2021
Date registered
27/05/2021
Date last updated
30/03/2022
Date data sharing statement initially provided
27/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does “real-time” ultrasound improve patient medication adherence?
Scientific title
Does “real-time” ultrasound improve patient medication adherence and increase patient willingness to take Disease Modifying Anti-Rheumatic Drugs in the treatment of inflammatory arthritis?
Secondary ID [1] 303861 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication adherence 321430 0
rheumatoid arthritis 321431 0
psoriatic arthritis 321432 0
Condition category
Condition code
Inflammatory and Immune System 319192 319192 0 0
Autoimmune diseases
Musculoskeletal 319226 319226 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 30-minute musculoskeletal ultrasound (MSK US) of clinically involved joint(s) by a rheumatologist trained in this imaging modality. During the session, participants will be shown real-time images of one or more inflamed joints. The operator will explain the anatomic landmarks (eg tendon, joint space, cartilage) and sonographic findings (eg, synovitis, erosion, effusion, doppler flow). Images will be compared to still sonographic pictures of a normal joint. The examination will take approximately 30 minutes on one occasion and will occur in a quiet darkened room.
Intervention code [1] 320191 0
Behaviour
Comparator / control treatment
Standard care involving a 30-minute education session with a rheumatology healthcare professional (explanation of rheumatoid/psoriatic arthritis and the medication mechanism of action and risks and benefits ) and provision of a Medication Information Sheet containing information regarding the relevant DMARD from the Australian Rheumatology Association website (www.rheumatology.org.au),
Control group
Active

Outcomes
Primary outcome [1] 327096 0
The Compliance Questionnaire-Rheumatology (CQR) will be used to assess patient medication adherence. The CQR is a 19-item Rheumatology-specific self-administered instrument with predictive validity when tested against objective measures such as Electronic Medication Event Monitoring. The total score calculated ranges from 0 (non-compliance) to 100 (maximum compliance) with a cut-off of >80 used to define satisfactory medication adherence. This tool has been well-validated in patients with IA.
Timepoint [1] 327096 0
24 weeks
Secondary outcome [1] 393770 0
1) Medication Adherence Rating Scale (MARS)
This self-report instrument consists of six questions relating to non-adherent behavior and has good validity and reliability in patients with a range of diseases, including IA and psoriasis. Responses to six items assess the frequency of unintentional (e.g. ‘I forgot’) and intentional (e.g. ‘I decided to miss a dose’) non-adherent behaviour are recorded using a 5-point Likert scale. The total score ranges from 6 to 30 with higher scores indicating higher self-reported adherence. Patients can be categorized into “high” or “low” adherers (MARS greater than or equal to 26 or lesser than or equal to 25). This outcome measure will be used with the CQR to determine if findings from the shorter MARS questionnaire correlate with those from the longer CQR. If so, the MARS may be a more convenient outcome measure in intervention studies assessing medication adherence.
Timepoint [1] 393770 0
Baseline, week 4, 12, 24
Secondary outcome [2] 393771 0
2) Patient willingness to escalate immunosuppression. This will be assessed using an anchored visual analogue scale (VAS; range 0-100), where 0 equals to not willing under any circumstances and 100 equals to definitely willing.
Timepoint [2] 393771 0
Screening, baseline
Secondary outcome [3] 393773 0
3) Multi-Dimensional Health Assessment Questionnaire (MD-HAQ) - a widely accepted measure of self-reported physical function, pain and global estimate in patients with IA.
Timepoint [3] 393773 0
Baseline, weeks 4, 12, 24
Secondary outcome [4] 393775 0
4) Brief Illness Perception Questionnaire (B-IPQ). This instrument was developed to assess illness adaptation to a range of diseases. Illness adaptation affects multiple psychological outcomes including ability to cope, mood and adherence to medical advice.
Timepoint [4] 393775 0
Baseline and weeks 4, 12, 24
Secondary outcome [5] 393780 0
5) Beliefs about Medicine Questionnaire (BMQ). This instrument contains 11 questions assessing cognitive representation about medication, in particular patient beliefs about the necessity of prescribed medication and their concerns regarding medication toxicity.
Timepoint [5] 393780 0
Baseline, weeks 4, 12, 24
Secondary outcome [6] 393781 0
6) EQ-5D-5L (www.euroqol.org). This is a comprehensive health-related QOL assessment tool used for over 30 years. Patients are asked to self-score their health in five domains (mobility, self care, usual activity, pain/discomfort and anxiety/depression). Data obtained allows calculation of Quality Adjusted Life Years.

Attendance at the trial site (Westmead Hospital) will be minimised by provision of blank questionnaires to be completed and returned in a stamped addressed envelope at specific times post-intervention: Week 4 (Timepoint 1), Week 12 (Timepoint 2) and Week 24 (Timepoint 3). Text reminders will be sent by investigators to study participants to prompt questionnaire completion at the appropriate time-points.
Timepoint [6] 393781 0
Baseline and at weeks 4, 12, 24
Secondary outcome [7] 393782 0
7) Patient experience of MSK US and patient education session. Participants in both groups will be given a blank white post-card at the end of the MSK US and patient education session to record their experience of the session in free text. Patients will be asked to place these in a sealed study box which will be opened at study conclusion for data analysis.
Timepoint [7] 393782 0
Baseline, immediately after intervention

Eligibility
Key inclusion criteria
• greater than or equal to 18 year old patients with RA or PsA as per internationally accepted criteria with disease duration less than 5 years;
• incompletely controlled RA or PsA (DAS 2.6-5.1) despite a csDMARD for greater than or equal to 3 months;
• patient willingness to escalate immunosuppression less than or equal to 50 on anchored visual analogue scale (VAS; range 0-100), where 0 equals not willing under any circumstances and 100 equals definitely willing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Extreme ill-health.
• Inability to provide informed consent for study participation.
• Non-English primary language
• Previous MSK US

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)
1:1 randomisation by coin toss.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using a two-tailed test with a significance level of 0.05, a sample size of 34 patients per group provides 90% power to detect a difference of 10 points on the CQR with a standard deviation (SD) of 12.54. Allowing for a 20% dropout rate, we aim to recruit 40 patients per group.

Data from postcards "patient experience of musculoskeletal ultrasound and patient education session" will be collated and managed using QSR NVivo 8 and thematically analysed using the Framework Method. A list of overall and individual themes will be compiled to allow for comparison between those randomised to standard care or intervention. Qualitative findings will be interpreted against other quantitative study data to provide further insight into patient perspectives and integration of both types of data to inform overall study findings.

Recruitment should be able to be performed over 24 months. Variables will be normally distributed, so an analysis of variance (ANOVA) will be used to compare the mean±SD of study parameters. P<0.05 will be considered statistically significant. Pearson correlation coefficients will be used to assess the relationship between patient beliefs and medication adherence. Any missing data will be imputed using the estimated regression mean method in StataTM.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
17/03/2022
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
80
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19062 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 33612 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 308258 0
Commercial sector/Industry
Name [1] 308258 0
Investigator-initiated funding scheme from Pfizer.
Country [1] 308258 0
Australia
Funding source category [2] 309771 0
Commercial sector/Industry
Name [2] 309771 0
Novartis Pharmaceuticals Australia Pty Limited
Country [2] 309771 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Westmead Hospital - Hawkesbury Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 309078 0
None
Name [1] 309078 0
none
Address [1] 309078 0
none
Country [1] 309078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308236 0
WSLHD HREC
Ethics committee address [1] 308236 0
Ethics committee country [1] 308236 0
Australia
Date submitted for ethics approval [1] 308236 0
31/03/2021
Approval date [1] 308236 0
13/05/2021
Ethics approval number [1] 308236 0

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

Contacts
Principal investigator
Name 110018 0
A/Prof Peter Wong
Address 110018 0
Department of Rheumatology, Westmead Hospital, Cnr Darcy and Hawkesbury Roads WESTMEAD NSW 2145
Country 110018 0
Australia
Phone 110018 0
+61 2 8890 8099
Fax 110018 0
Email 110018 0
[email protected]
Contact person for public queries
Name 110019 0
Peter Wong
Address 110019 0
Department of Rheumatology, Westmead Hospital, Cnr Darcy and Hawkesbury Roads WESTMEAD NSW 2145
Country 110019 0
Australia
Phone 110019 0
+61 0288908099
Fax 110019 0
Email 110019 0
[email protected]
Contact person for scientific queries
Name 110020 0
Peter Wong
Address 110020 0
Department of Rheumatology, Westmead Hospital, Cnr Darcy and Hawkesbury Roads WESTMEAD NSW 2145
Country 110020 0
Australia
Phone 110020 0
+61 0288908099
Fax 110020 0
Email 110020 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


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.