Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000574842
Ethics application status
Approved
Date submitted
22/03/2021
Date registered
17/05/2021
Date last updated
8/11/2021
Date data sharing statement initially provided
17/05/2021
Date results information initially provided
17/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Avoiding the “triple whammy”: Protocol for a randomized feasibility trial to test the effect of an information package for patients at increased risk of renal damage.
Scientific title
Avoiding the “triple whammy”: Protocol for a randomized feasibility trial to test the effect of an information package for patients at increased risk of renal damage who are already being prescribed angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers plus a diuretic.
Secondary ID [1] 303751 0
HRC 18-031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal impairment
 321216 0
Health literacy 321217 0
Condition category
Condition code
Renal and Urogenital 318994 318994 0 0
Kidney disease
Public Health 318995 318995 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 several self-marking quizzes to reinforce learning for each short module. The online task takes about 10-15 minutes. 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. Web portal analytics will be used to evaluate use of the online activity and corroborate self-reported use.
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] 320065 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] 326917 0
Feasibility of the study procedures for recruiting patients will be assessed by calculating the proportion of participating patients relative to patients eligible to participate by review of medical records.
Timepoint [1] 326917 0
Cumulative baseline data will be assessed at the conclusion of recruitment.
Primary outcome [2] 326918 0
Acceptability of the patient information package will be assessed using a study-specific questionnaire
Timepoint [2] 326918 0
At 2 weeks post-intervention commencement for the intervention group only
Secondary outcome [1] 393136 0
Participant knowledge regarding the risk of NSAIDs will be assessed by a study-specific questionnaire.
Timepoint [1] 393136 0
Baseline for all participants, and at 2 and 4 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. Attend a general practice in the Northland region of 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 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
Actual
12/04/2021
Date of last participant enrolment
Anticipated
Actual
19/04/2021
Date of last data collection
Anticipated
Actual
6/05/2021
Sample size
Target
50
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 23555 0
New Zealand
State/province [1] 23555 0
Northland

Funding & Sponsors
Funding source category [1] 308158 0
Government body
Name [1] 308158 0
Health Research Council of New Zealand
Country [1] 308158 0
New Zealand
Primary sponsor type
Individual
Name
Sharon Leitch
Address
Department of General Practice and Rural Health
University of Otago Medical School
55 Hanover Street, Dunedin Central, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 308927 0
Individual
Name [1] 308927 0
Tim Stokes
Address [1] 308927 0
Department of General Practice and Rural Health
University of Otago Medical School
55 Hanover Street, Dunedin Central, Dunedin 9016
Country [1] 308927 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308143 0
University of Otago Human Research Ethics Committee
Ethics committee address [1] 308143 0
University of Otago
362 Leith Street, North Dunedin, Dunedin 9016
Ethics committee country [1] 308143 0
New Zealand
Date submitted for ethics approval [1] 308143 0
11/02/2021
Approval date [1] 308143 0
04/03/2021
Ethics approval number [1] 308143 0
H21/016

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.

A randomised controlled trial was proposed 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. To ensure best use of resources and enhance the likelihood of success of a RCT, we intend to conduct this feasibility study to determine if the methods proposed are suitable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109686 0
Dr Sharon Leitch
Address 109686 0
Department of General Practice and Rural Health
Dunedin School of Medicine, University of Otago
55 Hanover Street, Dunedin Central, Dunedin 9016
Country 109686 0
New Zealand
Phone 109686 0
+64212619996
Fax 109686 0
Email 109686 0
[email protected]
Contact person for public queries
Name 109687 0
Dr Sharon Leitch
Address 109687 0
Department of General Practice and Rural Health
Dunedin School of Medicine, University of Otago
55 Hanover Street, Dunedin Central, Dunedin 9016
Country 109687 0
New Zealand
Phone 109687 0
+64212619996
Fax 109687 0
Email 109687 0
[email protected]
Contact person for scientific queries
Name 109688 0
Dr Sharon Leitch
Address 109688 0
Department of General Practice and Rural Health
Dunedin School of Medicine, University of Otago
55 Hanover Street, Dunedin Central, Dunedin 9016
Country 109688 0
New Zealand
Phone 109688 0
+64212619996
Fax 109688 0
Email 109688 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?
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 [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11113Study protocol  [email protected]
11114Ethical approval  [email protected]
11115Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo This feasibility study demonstrated that email fr... [More Details]

Documents added automatically
No additional documents have been identified.