None listed
Conditions
Brief summary
This randomised controlled trial is the third phase of the ReMedi project and will evaluate a co-designed, consumer-focused digital platform to support reporting and management of medicine side-effects. The ReMedi platform enables consumers to easily report side-effects directly to the Therapeutic Goods Administration (TGA), share reports with their healthcare professionals, and keep a personal record of their experiences. The service aims to empower consumers to recognise and report medicine side-effects early and to support follow-up care by pharmacists and general practitioners. By improving consumer engagement in side-effects reporting, ReMedi may increase both the number and quality of reports submitted to the TGA, helping to strengthen medicine safety monitoring and regulatory decision-making. The trial will compare ReMedi alone with ReMedi plus SMS reminders to assess feasibility, usability, and implementation in real-world community pharmacy and general practice settings. The study will recruit 806 participants from sites in Adelaide, South Australia. The expected outcome is an easy-to-use, stakeholder-acceptable platform for medicine side-effect reporting and management that enhances consumer engagement.
Interventions
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-u
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.
Sponsors
Adelaide University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
Inability to understand or communicate in English. Cognitive or physical impairment preventing use of smartphones, tablets and personal computers.
Outcome results
None listed