Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000654156
Ethics application status
Approved
Date submitted
29/04/2019
Date registered
1/05/2019
Date last updated
14/05/2019
Date data sharing statement initially provided
1/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can providing information about a generic medicine switch reduce side effect reporting?
Scientific title
Can providing information about a generic medicine switch reduce side effect reporting in patients taking lamotrigine for epilepsy and bipolar disorder?
Secondary ID [1] 298006 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients taking lamotrigine for epilepsy 312452 0
Patients taking lamotrigine for bipolar disorder 312453 0
Condition category
Condition code
Mental Health 311001 311001 0 0
Other mental health disorders
Neurological 311002 311002 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are going to be switched to a generic medicine as a result of a funding change by PHARMAC, New Zealand. Participants will be sent one text message from their pharmacy, two weeks before they are scheduled to switch to a generic medicine. The text will contain one of two different messages (intervention or active control text), which participants have been randomly allocated to. The intervention text message will notify patients that their brand of lamotrigine has changed as well as provide them with a 2 minute animated video, designed specifically for this study. This video discusses the nocebo effect and how this is relevant to the medicine switch by 1) becoming more aware of physical symptoms & 2) inappropriately misattributing them to the effects of a switch.
Intervention code [1] 314244 0
Treatment: Other
Intervention code [2] 314329 0
Behaviour
Comparator / control treatment
The active control group will receive a text message from their pharmacy two weeks before they are scheduled to switch to a generic medicine. This message will notify patients that their brand of lamotrigine has changed.
Control group
Active

Outcomes
Primary outcome [1] 319801 0
The number of side effects experienced from a list of 50 symptoms based on the General Assessment of Side Effects Scale (Rief et al., 2011).
Timepoint [1] 319801 0
Three weeks after participants have changed to the new generic medicine
Secondary outcome [1] 369574 0
Efficacy rating of the new generic using a scale from 0 "Does not work well" to 10 "Works extremely well"
Timepoint [1] 369574 0
Three weeks after changing to the new generic medicine

Eligibility
Key inclusion criteria
Participants must be a patient of Green Cross Health - a New Zealand provider of primary care services. They must be taking either Lamictal or Arrow-lamotrigine before the medicine change. They must have a mobile phone number on file in the Green Cross database.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Are taking Logem before the switch (i.e. will not be switching medicine brands) and do not have a mobile phone number in the Green Cross database

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
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
20/05/2019
Actual
Date of last participant enrolment
Anticipated
31/10/2019
Actual
Date of last data collection
Anticipated
21/11/2019
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment outside Australia
Country [1] 21421 0
New Zealand
State/province [1] 21421 0

Funding & Sponsors
Funding source category [1] 302531 0
Government body
Name [1] 302531 0
Pharmac New Zealand
Country [1] 302531 0
New Zealand
Primary sponsor type
Individual
Name
Professor Keith Petrie
Address
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland

2 Park Rd
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 302442 0
Individual
Name [1] 302442 0
Kate MacKrill
Address [1] 302442 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
University of Auckland

2 Park Rd
Grafton
Auckland 1023
New Zealand
Country [1] 302442 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303180 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 303180 0
The University of Auckland
49 Symonds Street
Private Bag 92019
Auckland, New Zealand
Ethics committee country [1] 303180 0
New Zealand
Date submitted for ethics approval [1] 303180 0
Approval date [1] 303180 0
15/04/2019
Ethics approval number [1] 303180 0
022873

Summary
Brief summary
The purpose of this study is to investigate the effect of a text message notification and additional information on adjustment to a new medication brand. It is hypothesised that participants who receive additional nocebo information will report fewer side effects and have a greater perceived efficacy of the new medicine compared to a group who are just notified that their medicine brand is going to change.

Participants will be allocated to one of two groups: either a group who are sent a text message that their medicine is changing, or a group sent this text as well as a brief video explaining the nocebo effect. Three weeks after the switch to the generic medicine, participants will be sent an online survey asking them about any side effects experienced and perceived efficacy of the new medicine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92766 0
Prof Keith Petrie
Address 92766 0
Department of Psychological Medicine
University of Auckland
2 Park Rd
Grafton
Auckland 1023
Country 92766 0
New Zealand
Phone 92766 0
+64 9 923 6564
Fax 92766 0
Email 92766 0
[email protected]
Contact person for public queries
Name 92767 0
Keith Petrie
Address 92767 0
Department of Psychological Medicine
University of Auckland
2 Park Rd
Grafton
Auckland 1023
Country 92767 0
New Zealand
Phone 92767 0
+64 9 923 6564
Fax 92767 0
Email 92767 0
[email protected]
Contact person for scientific queries
Name 92768 0
Keith Petrie
Address 92768 0
Department of Psychological Medicine
University of Auckland
2 Park Rd
Grafton
Auckland 1023
Country 92768 0
New Zealand
Phone 92768 0
+64 9 923 6564
Fax 92768 0
Email 92768 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The approved ethics application stated that participants' individual data will be anonymous and confidential. Therefore the information is private to the University of Auckland researchers and participant.


What supporting documents are/will be available?

No Supporting Document Provided



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.