ANZCTR - Registration

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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 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]

HRC 18-031

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Renal impairment

Health literacy

Condition category

Condition code

Renal and Urogenital

Kidney disease

Public Health

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]

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]

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]

Cumulative baseline data will be assessed at the conclusion of recruitment.

Primary outcome [2]

Acceptability of the patient information package will be assessed using a study-specific questionnaire

Timepoint [2]

At 2 weeks post-intervention commencement for the intervention group only

Secondary outcome [1]

Participant knowledge regarding the risk of NSAIDs will be assessed by a study-specific questionnaire.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Northland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

PO Box 5541, Victoria Street West, Auckland 1142

Country [1]

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]

Individual

Name [1]

Tim Stokes

Address [1]

Department of General Practice and Rural Health
University of Otago Medical School
55 Hanover Street, Dunedin Central, Dunedin 9016

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Research Ethics Committee

Ethics committee address [1]

University of Otago
362 Leith Street, North Dunedin, Dunedin 9016

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

11/02/2021

Approval date [1]

04/03/2021

Ethics approval number [1]

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

Dr Sharon Leitch

Address

Department of General Practice and Rural Health
Dunedin School of Medicine, University of Otago
55 Hanover Street, Dunedin Central, Dunedin 9016

Country

New Zealand

Phone

+64212619996

Fax

sharon.leitch@otago.ac.nz

Contact person for public queries

Name

Sharon Leitch

Address

Department of General Practice and Rural Health
Dunedin School of Medicine, University of Otago
55 Hanover Street, Dunedin Central, Dunedin 9016

Country

New Zealand

Phone

+64212619996

Fax

sharon.leitch@otago.ac.nz

Contact person for scientific queries

Name

Sharon Leitch

Address

Department of General Practice and Rural Health
Dunedin School of Medicine, University of Otago
55 Hanover Street, Dunedin Central, Dunedin 9016

Country

New Zealand

Phone

+64212619996

Fax

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.	Type	Email
11113	Study protocol	sharon.leitch@otago.ac.nz
11114	Ethical approval	sharon.leitch@otago.ac.nz
11115	Informed consent form	sharon.leitch@otago.ac.nz

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.

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