Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001132730
Ethics application status
Approved
Date submitted
15/08/2022
Date registered
17/08/2022
Date last updated
21/05/2024
Date data sharing statement initially provided
17/08/2022
Date results information initially provided
21/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Avoiding Anti-inflammatories: a randomized controlled trial testing the use of an information package on patient knowledge and behaviour
Scientific title
Avoiding Anti-inflammatories: a randomized controlled trial testing the use of an information package on the knowledge and behaviour of patients prescribed angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers.
Secondary ID [1] 307778 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
This RCT is based on the feasibility trial ACTRN12621000574842

Health condition
Health condition(s) or problem(s) studied:
Renal impairment
 327356 0
Health Literacy 327357 0
Condition category
Condition code
Renal and Urogenital 324481 324481 0 0
Kidney disease
Public Health 324482 324482 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group patients will be emailed a link to a webpage containing a downloadable PDF and a fully accessible online interactive learning activity. Both the PDF and interactive learning activity have been designed specifically for this project. The single A4 page PDF provides background information about the potential drug interactions and effect on the kidneys, as well as advice about avoiding non-steroidal anti-inflammatory medication. Participants can download and print this information if they would like. The interactive learning activity provides more detailed information about the potential harms associated with non-steroidal anti-inflammatory medication, and potential drug interactions. There are self-marking quizzes to reinforce learning for each short module. Participants will complete 4 modules in the online learning activity, which takes about 10-15 minutes to complete in total. Participants can access the online learning activity as many times as they like during the two week study period. Administration of the intervention will occur by automatic email at time of randomisation. Use of the intervention will be assessed by self-report in the follow-up survey.
The intervention group will also receive usual general practice care from their own primary care team. Usual general practice care means patients can contact their general practice as often as they like during normal business hours to speak with a healthcare provider, have a clinical appointment, receive advice or any clinical treatment deemed necessary, or be referred on for secondary care if required.
Intervention code [1] 324241 0
Treatment: Other
Comparator / control treatment
Control treatment will receive usual general practice care from their own primary care team.
Control group
Active

Outcomes
Primary outcome [1] 332302 0
Participant knowledge regarding the risk of NSAIDs will be assessed by a study-specific questionnaire.
Timepoint [1] 332302 0
Baseline for all participants, and at 2 weeks post-randomisation for both the intervention and control groups
Secondary outcome [1] 412909 0
Self-reported behaviour change regarding personal NSAID use will be assessed by a study-specific questionnaire
Timepoint [1] 412909 0
Baseline for all participants, and at 2 weeks post-randomisation for both the intervention and control groups

Eligibility
Key inclusion criteria
1. Must be prescribed an angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, PLUS a diuretic in the past 3 months
2. Must be a registered patient at a general practice in Aotearoa New Zealand
3. Have signed up to receive emails from Conporto Health Ltd
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Do not take the prerequisite medication
2. Do not complete the consent process

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)
Randomisation will occur centrally using the randomisation module in REDCap survey software using a randomisation schedule uploaded prior to the commencement of the study. Each patient will be randomised once they consent to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation schedule will be developed using Stata statistical software
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
Safety/efficacy
Statistical methods / analysis
Linear mixed models will be used to compare the changes in the mean score on the NSAID knowledge questionnaire and self-reported NSAID use between the two arms. All parameters will be analysed by demographic characteristics including gender, age and ethnicity

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/09/2022
Actual
30/10/2022
Date of last participant enrolment
Anticipated
17/10/2022
Actual
18/12/2022
Date of last data collection
Anticipated
31/10/2022
Actual
27/01/2023
Sample size
Target
200
Accrual to date
Final
408
Recruitment outside Australia
Country [1] 24955 0
New Zealand
State/province [1] 24955 0

Funding & Sponsors
Funding source category [1] 312050 0
University
Name [1] 312050 0
University of Otago
Country [1] 312050 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
Department of General Practice and Rural Health
55 Hanover street
Dunedin 9016
New Zealand
Country
New Zealand
Secondary sponsor category [1] 313553 0
Individual
Name [1] 313553 0
Dr Sharon Leitch
Address [1] 313553 0
University of Otago
Department of General Practice and Rural Health
55 Hanover street
Dunedin 9016
New Zealand
Country [1] 313553 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311462 0
University of Otago Human Ethics Committee
Ethics committee address [1] 311462 0
Human Ethics Committee
University of Otago
362 Leith Street, Dunedin 9016
New Zealand
Ethics committee country [1] 311462 0
New Zealand
Date submitted for ethics approval [1] 311462 0
14/02/2022
Approval date [1] 311462 0
28/02/2022
Ethics approval number [1] 311462 0
H22/027

Summary
Brief summary
Non-steroidal anti-inflammatory drugs (NSAIDs) are a common cause of renal damage. The risk of renal injury dramatically increases when NSAIDs are taken together with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARBs) plus a diuretic– this is known as the “triple whammy” combination. Co-prescribing of these medications is still common in New Zealand, and patients can easily buy NSAIDs independently of their doctor. Providing information directly to patients may help address some of those issues.

We have developed patient educational material including a printable information sheet, a webpage and an online learning activity with collaborative input from patients, GPs, pharmacists, and a patient education provider. These resources aim to inform patients about their elevated risk of harm from NSAIDs, and discourage them from using over-the-counter NSAIDs. We have tested this material in a feasibility trial (ACTRN12621000574842).

A randomised controlled trial is now planned to examine the effect of giving patients at-risk harm from the “triple whammy” (because of the combination of long-term medications they are prescribed) this information directly, without needing their health care practitioners to provide it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121178 0
Dr Sharon Leitch
Address 121178 0
University of Otago
Department of General Practice and Rural Health
55 Hanover street
Dunedin 9016
New Zealand
Country 121178 0
New Zealand
Phone 121178 0
+64 212619996
Fax 121178 0
Email 121178 0
sharon.leitch@otago.ac.nz
Contact person for public queries
Name 121179 0
Dr Sharon Leitch
Address 121179 0
University of Otago
Department of General Practice and Rural Health
55 Hanover street
Dunedin 9016
New Zealand
Country 121179 0
New Zealand
Phone 121179 0
+64 212619996
Fax 121179 0
Email 121179 0
sharon.leitch@otago.ac.nz
Contact person for scientific queries
Name 121180 0
Dr Sharon Leitch
Address 121180 0
University of Otago
Department of General Practice and Rural Health
55 Hanover street
Dunedin 9016
New Zealand
Country 121180 0
New Zealand
Phone 121180 0
+64 212619996
Fax 121180 0
Email 121180 0
sharon.leitch@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it who provide a methodologically sound proposal
Available for what types of analyses?
To achieve the aims of the approved proposal
How or where can data be obtained?
Access subject to approval by Principal Investigator. Email sharon.leitch@otago.ac.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16912Study protocol  sharon.leitch@otago.ac.nz
16913Ethical approval  sharon.leitch@otago.ac.nz
16914Informed consent form  sharon.leitch@otago.ac.nz



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo The 201 participants who completed the study had h... [More Details]

Documents added automatically
No additional documents have been identified.