Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000140358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/01/2026
Date registered
Help: Date registered
4/02/2026
Date last updated
Help: Date last updated
4/02/2026
Date data sharing statement initially provided
Help: Data sharing statement date
4/02/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a new digital platform (ReMedi) to help people report and manage side effects from medicines
Scientific title
Implementation and evaluation of a co-designed digital platform (ReMedi) for consumer reporting and management of adverse drug events: a feasibility randomised controlled trial
Additional trial identifiers [1] 316251 0
National Health and Medical Research Council (NHMRC) Ideas Grant GNT2020626
Universal Trial Number (UTN)
Trial acronym
ReMedi
Related trial records

Health condition
Health condition(s) studied:
Adverse Drug Events 340284 0
Condition category
Condition code
Public Health 336483 336483 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention involves consumers using a digital tool (ReMedi) to report any new symptoms or suspected adverse drug events (ADEs) they may experience after commencing on a medicine that is new to them. Consumers can access the platform using a web browser on their smart phone/device or computer. Interaction with the platform will involve completion of an ADE questionnaire, which takes approximately 10 minutes to complete and may be used by consumers on an ad hoc basis during a 30-day follow-up period when they experience an ADE and wish to make a report. The questionnaire will collect information on participant demographics (age, sex), details of symptoms (type, severity, current status, and duration), the suspected medicine (brand or generic name, prescribed or non-prescribed, dose, frequency, duration of use, and indication, if known), comorbidities, and other concomitant medicines. Responses will be provided using pre-specified options, with free-text entry available for selected items.

With the consumer’s consent, their report will be sent to their GP and/or pharmacist who consent to receive the report to support targeted assessment and management of the reported ADE. After reviewing a copy of the reports, the GP or pharmacist may contact the consumer to discuss and/or manage the reported ADE.

For consumers who have provided additional consent, a copy of their reports will also be shared with the TGA. Participants may choose whether or not they wish to be contacted by the TGA for further information about their report, if needed. If they agree, the research team will share the participants’ report along with their contact details to the TGA. If they do not, only a de-identified copy of their report will be shared, unless they choose not to have their report shared at all.

Consumers will have the option to download a PDF copy of their ADE report, which they may choose to share with any of their healthcare professionals or keep it for their own records.
Intervention code [1] 332962 0
Early detection / Screening
Description of the comparator or control
The comparator (intervention-plus group) will use ReMedi, and in addition, receive SMS prompts on days 2, 7, 14, and 30 after starting a newly prescribed/dispensed medicine. The prompts will ask the consumers whether they have experienced any new symptoms or suspected ADEs. Consumers who indicate they have experienced a new symptom or suspected ADE will be guided to report the event through the platform.

Regardless of previous prompts, participants will continue to receive subsequent prompts to check for any new or additional symptoms or suspected ADEs (e.g., on days 7, 14, and 30). If a participant does not respond to an SMS within 24 hours, a reminder message will be sent. As a result, each consumer in the intervention–plus group will receive a minimum of 4 and a maximum of 8 SMS messages over the 30-day follow-up period.
Control group
Active

Outcomes
Primary outcome [1] 344019 0
Usability of ReMedi by consumers
Timepoint [1] 344019 0
As soon as possible after a consumer submits an ADE report (Anytime between day 2 to day 30 post-baseline)
Primary outcome [2] 344020 0
Process evaluation: the implementation process (what works, where, and why), the acceptability of, and satisfaction with the platform
Timepoint [2] 344020 0
At the end of the study
Secondary outcome [1] 456471 0
The total number of ADE reports
Timepoint [1] 456471 0
From day 2 to day 30 post-baseline, as events occur
Secondary outcome [2] 456472 0
The proportion of ADE reports per consumer
Timepoint [2] 456472 0
From day 2 to day 30 post-baseline, as events occur
Secondary outcome [3] 456959 0
The proportion of ADE per newly prescribed medication
Timepoint [3] 456959 0
From day 2 to day 30 post-baseline, as events occur
Secondary outcome [4] 456960 0
The number of ADEs consumers consented to be shared with the TGA
Timepoint [4] 456960 0
From day 2 to day 30 post-baseline, as events occur
Secondary outcome [5] 456961 0
The number and proportion of ADE reports shared with HCPs
Timepoint [5] 456961 0
From day 2 to day 30 post-baseline, as events occur
Secondary outcome [6] 456962 0
The number and proportion of reports reviewed by HCPs
Timepoint [6] 456962 0
From day 2 to day 30 post-baseline, as events occur
Secondary outcome [7] 456963 0
The number and type of treatment changes prompted by the detected ADE (e.g., dose adjustments, medication discontinuation, pharmacologic and non-pharmacologic management) along with the timing of these changes.
Timepoint [7] 456963 0
From day 2 to day 30 post-baseline, as events occur
Secondary outcome [8] 456964 0
The number of consumer self-initiated vs. HCP-recommended treatment changes.
Timepoint [8] 456964 0
From day 2 to day 30 post-baseline, as events occur

Eligibility
Key inclusion criteria
Adult consumers (greater than or equal to 18 years) or parents of children (<18 years) residing in South Australia

Prescribed or dispensed a prescription-only or pharmacist-only medicine that is new to them.

Own or have access to a smartphone/tablet/personal computer with internet connectivity.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Inability to understand or communicate in English.

Cognitive or physical impairment preventing use of smartphones, tablets and personal computers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/02/2026
Actual
Date of last participant enrolment
Anticipated
15/11/2026
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
806
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 320855 0
Government body
Name [1] 320855 0
National Health and Medical Research Council (NHMRC)
Country [1] 320855 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
Country
Australia
Secondary sponsor category [1] 323555 0
None
Name [1] 323555 0
Address [1] 323555 0
Country [1] 323555 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319389 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 319389 0
Ethics committee country [1] 319389 0
Australia
Date submitted for ethics approval [1] 319389 0
22/10/2025
Approval date [1] 319389 0
04/12/2025
Ethics approval number [1] 319389 0
207436

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

Contacts
Principal investigator
Name 147178 0
A/Prof Renly Lim
Address 147178 0
Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Biomedical Science, Adelaide University, Frome Rd, Adelaide, South Australia 5000
Country 147178 0
Australia
Phone 147178 0
+61 8 830 22307
Fax 147178 0
Email 147178 0
[email protected]
Contact person for public queries
Name 147179 0
Eyob Alemayehu Gebreyohannes
Address 147179 0
Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Biomedical Science, Adelaide University, Frome Rd, Adelaide, South Australia 5000
Country 147179 0
Australia
Phone 147179 0
+61 8 830 24278
Fax 147179 0
Email 147179 0
[email protected]
Contact person for scientific queries
Name 147180 0
Renly Lim
Address 147180 0
Quality Use of Medicines and Pharmacy Research Centre, School of Pharmacy and Biomedical Science, Adelaide University, Frome Rd, Adelaide, South Australia 5000
Country 147180 0
Australia
Phone 147180 0
+61 8 830 22307
Fax 147180 0
Email 147180 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Access subject to approvals by Principal Investigator [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    ReMedi Implementation protocol_V2_15 Jan 2026_ANZCTR.pdf


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.