Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000483954
Ethics application status
Approved
Date submitted
26/03/2020
Date registered
17/04/2020
Date last updated
1/06/2023
Date data sharing statement initially provided
17/04/2020
Date results information initially provided
3/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Patients' perceptions and beliefs of Methotrexate for inflammatory arthritis: An Intervention Study
Scientific title
The efficacy of a brief mindset intervention on perceptions and beliefs towards methotrexate in patients with a new diagnosis of inflammatory arthritis
Secondary ID [1] 300860 0
None
Universal Trial Number (UTN)
U1111-1250-1144
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory arthritis
 316772 0
Side effects of methotrexate 316898 0
Condition category
Condition code
Inflammatory and Immune System 315000 315000 0 0
Rheumatoid arthritis
Inflammatory and Immune System 315004 315004 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Viewing methotrexate symptoms as positive signals (SAPS) intervention:
The SAPS intervention will consist of a 5-minute video, delivered on an iPad, by a Health Psychology masters student at Greenlane Clinical Centre in Auckland. The SAPS intervention will be delivered within one-week of the participant starting methotrexate. The SAPS intervention video will provide information about what people can expect when they are using methotrexate to treat their inflammatory arthritis. The video explains how methotrexate works in the body and the importance of ongoing monitoring of health while taking methotrexate. The video further outlines strategies for how to cope with uncomfortable, but medically safe symptoms that are associated with Methotrexate, particularly through being encouraged to view these uncomfortable but medically safe symptoms as positive signals that the methotrexate is active in the body as intended.
Participants will be given a hand out designed specifically for the study that summarises the content of the video before they leave.
Two weeks after seeing the SAPS intervention video, participants will receive a booster session via phone call (10-minutes). This booster session will remind participants of the topics covered in the intervention video.
Intervention code [1] 317190 0
Treatment: Other
Comparator / control treatment
Attention-control symptoms as side-effects (SASE) condition:
The SASE control condition will consist of a 5-minute video, delivered on an iPad, by a Health Psychology masters student at Greenlane Clinical Centre in Auckland. The SASE video will be delivered within one-week of the participant starting methotrexate. The SASE control video will provide the same information as the SAPS intervention video about what people can expect when they are using methotrexate to treat their inflammatory arthritis. The video explains how methotrexate works in the body and the importance of ongoing monitoring of health while taking methotrexate. In line with current standard-care, medically safe side-effects of methotrexate are discussed and common strategies of their management are mentioned.
Participants will be given a hand out designed specifically for the study that summarises the content of the video before they leave.
Two weeks after seeing the SASE control video, participants will receive a booster session via phone call (10-minutes). This booster session will remind participants of the topics covered in the intervention video.
Control group
Active

Outcomes
Primary outcome [1] 323309 0
Side effect attribution measured with the Side Effect Attribution Scale (MacKrill et al., 2020)
Timepoint [1] 323309 0
At baseline and one month after starting methotrexate.
Secondary outcome [1] 381511 0
Perceptions of methotrexate assessed using the Brief Illness Perception Questionnaire (BIPQ) (Broadbent, Petrie, Main, & Weinman, 2006)
Timepoint [1] 381511 0
At baseline and one month after starting methotrexate.
Secondary outcome [2] 381512 0
Perceptions of inflammatory arthritis assessed using the BIPQ (Broadbent, Petrie, Main, & Weinman, 2006)
Timepoint [2] 381512 0
At baseline and one month after starting methotrexate
Secondary outcome [3] 381513 0
Relationship between mindset and motivation to use methotrexate measured with Meta-Mindset Measure (Santoro et al, 2020) and mindset items adapted from Howe et al. (2019)
Timepoint [3] 381513 0
One month after starting methotrexate.
Secondary outcome [4] 381514 0
Difference between groups in symptom occurrence using the Side Effect Attribution Scale (MacKrill et al., 2020)
Timepoint [4] 381514 0
Baseline and one month after starting methotrexate.
Secondary outcome [5] 381515 0
Difference in adherence to methotrexate measured by self-report of number of doses missed.
Timepoint [5] 381515 0
One month after starting methotrexate.
Secondary outcome [6] 408085 0
C-Reactive Protein levels in routine blood test results established through participant's standard clinical notes.
Timepoint [6] 408085 0
Closest blood test to the date the participant completed the baseline questionnaire, and then blood tests completed closest to 1 month (4 weeks) and 3 months (12 weeks) from the baseline completion date .
Secondary outcome [7] 408086 0
Continuation of Methotrexate as a binary yes/no variable established through participant's standard clinical notes.
Timepoint [7] 408086 0
3 months (12 weeks) from the date that the participant completed the baseline questionnaire.

Eligibility
Key inclusion criteria
New diagnosis of an inflammatory arthritis condition, for which low-dose methotrexate is prescribed.
Patients who are attending the rheumatology clinic at Greenlane Clinical Centre in Auckland.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous prescription or use of methotrexate.
Those who feel unable to complete questionnaires and participate and/or understand English.
Lack of access to a phone.

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)
Sealed opaque envelopes.
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 receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size and power calculation:
We are aiming to recruit 58 participants for the current study (29 participants in each study arm). This is based off a G*Power calculation which suggested that 48 participants would be required using a repeated measures between-within ANOVA to measure differences in symptom attribution to methotrexate depending on group membership, with 80% power at a significance level of p= .05 and a small-medium effect size (f=.21). This effect size was taken from previous research into the effects of mindset inventions in health contexts (Crum, Salovey & Achor, 2013; Howe et al., 2019). We are aiming for 58 participants to account for a possible 20% attrition rate.

Statistical analysis:
Repeated-measures between-within ANOVA will be used to assess differences between study groups, from baseline to 1-month follow-up in symptom occurrence, methotrexate, mindset, illness and treatment perceptions, and disease status. Pearson’s Chi-square test will be used to assess differences between the two groups in self-reported adherence. Independent samples t-tests will be conducted to assess differences in groups’ symptom attribution. Independent samples t-tests and Chi-Square for independence will also be used to assess differences between groups in demographic variables and baseline measures.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
27/07/2020
Actual
29/07/2020
Date of last participant enrolment
Anticipated
30/09/2022
Actual
7/05/2023
Date of last data collection
Anticipated
30/07/2023
Actual
Sample size
Target
58
Accrual to date
Final
47
Recruitment outside Australia
Country [1] 22454 0
New Zealand
State/province [1] 22454 0
Auckland

Funding & Sponsors
Funding source category [1] 305313 0
University
Name [1] 305313 0
University of Auckland
Country [1] 305313 0
New Zealand
Primary sponsor type
Individual
Name
Professor Keith Petrie
Address
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
22-30 Park Avenue, Grafton
Auckland
1023
Country
New Zealand
Secondary sponsor category [1] 305685 0
Individual
Name [1] 305685 0
Rachael Yielder
Address [1] 305685 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland
22-30 Park Avenue, Grafton
Auckland
1023
Country [1] 305685 0
New Zealand
Other collaborator category [1] 281251 0
Individual
Name [1] 281251 0
Professor Nicola Dalbeth
Address [1] 281251 0
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road, Grafton
Auckland
1023
Country [1] 281251 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305651 0
Health and Disability Ethics Committee
Ethics committee address [1] 305651 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 305651 0
New Zealand
Date submitted for ethics approval [1] 305651 0
27/03/2020
Approval date [1] 305651 0
11/05/2020
Ethics approval number [1] 305651 0

Summary
Brief summary
The objective of the study is to determine the efficacy of a brief mindset intervention in improving participants’ beliefs and perception of low-dose methotrexate used to treat their inflammatory arthritis. The study also aims to investigate whether the brief mindset intervention will result in reduced burden of symptoms associated with methotrexate, and improved adherence in the initial stages of treatment. Specifically, we hypothesise that the intervention group will have more positive beliefs and perceptions towards methotrexate, that they will find associated symptoms less burdensome, and have better initial adherence to the treatment, compared to the active control condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101094 0
Prof Keith Petrie
Address 101094 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 101094 0
New Zealand
Phone 101094 0
+64 9 923 6564
Fax 101094 0
Email 101094 0
[email protected]
Contact person for public queries
Name 101095 0
Prof Keith Petrie
Address 101095 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 101095 0
New Zealand
Phone 101095 0
+64 9 923 6564
Fax 101095 0
Email 101095 0
[email protected]
Contact person for scientific queries
Name 101096 0
Prof Keith Petrie
Address 101096 0
Department of Psychological Medicine
The University of Auckland
Private Bag 92019
Auckland 1142
Country 101096 0
New Zealand
Phone 101096 0
+64 9 923 6564
Fax 101096 0
Email 101096 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.