Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000510640
Ethics application status
Approved
Date submitted
3/05/2023
Date registered
17/05/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
17/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an enhanced medication information sheet improve drug responsiveness?
Scientific title
Assessing whether an enhanced medication information sheet can increase the placebo response, decrease the nocebo response and make information easier to understand and more impactful for users.
Secondary ID [1] 309492 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Health literacy 329762 0
Placebo response 329763 0
Nocebo response 329764 0
Condition category
Condition code
Mental Health 326872 326872 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be one 1-hour face-to-face session for the participants with the student researcher. After baseline measures have been completed, participants will be randomised into the control or experimental group and asked to carefully read either a standard medication information sheet for Metoprolol or an enhanced medication information sheet. The enhanced medication information sheet has been adapted to increase the placebo response by boosting treatment expectations, reduce the nocebo response by using positive framing of risk information and explaining the nocebo effect to participants. The enhanced medication information sheet has also been adapted to be more user-friendly. It uses simpler language compared with the standard sheet, pictograms and a more reader-friendly layout of information. Both medication information sheets are double-sided and A4 in size. The medication sheet is only intended for the use of this study and is not a readily available source.


Both researcher and participant will be blinded to which group the participant is in. The researcher will step out of the clinic room while the participant reads the medication information sheet to ensure the participant’s group allocation remains concealed. The participant will be asked to put the information sheet back in the envelope after they have read the information sheet and notify the researcher once completing this.

All participants will be asked to take one 50mg dose of Metoprolol (actually a placebo pill consisting of microcrystalline cellulose) and fill out questionnaires while waiting for the drug to "take effect" (10 minutes). The student researcher will supervise participants taking the placebo tablet. All participants then complete the Trier Social Stress Test (TSST), which is a brief laboratory-based stress task. In both conditions, further measures will be collected immediately after participants complete the brief stress task.

In both conditions, participants will be asked to complete follow-up questionnaires 24 hours after the intervention.
Intervention code [1] 325920 0
Treatment: Other
Comparator / control treatment
The control group will be given a standard medication information sheet for Metoprolol (taken from Medsafe New Zealand and shortened to two pages for the purposes of this study).
Control group
Active

Outcomes
Primary outcome [1] 334528 0
The primary outcome is the placebo response which is a composite primary outcome. The placebo response will be demonstrated by changes in blood pressure and heart rate, measured using the iHealth Wireless Blood Pressure Monitor. Using an inflatable cuff around the upper arm, this device measures a person’s systolic and diastolic blood pressure and heart rate. The placebo response will also be assessed by measuring participants' anxiety using The Short Form State-Trait Anxiety Inventory (STAI- 6) (Marteau & Bekker, 1992).
Timepoint [1] 334528 0
Post TSST (primary endpoint) and 24 hours post-intervention
Primary outcome [2] 334529 0
The nocebo response (side effect reporting measured with the Side Effect Attribution Scale - SEAS) (MacKrill, Webster, et al., 2021)
Timepoint [2] 334529 0
Post TSST (primary endpoint) and 24 hours post-intervention
Secondary outcome [1] 420998 0
Satisfaction - Seven statements will assess participants' satisfaction with the medication information sheet they were given by covering the clarity of the information, the type of information provided, and overall satisfaction. The statements assess if the medication information sheet 1) Is clear, 2) Had words participants did not understand 3) was reassuring, 4) was interesting 5) helped participants understand risks and benefits 6) Was well-designed 7) overall satisfaction. Response choices will range from 1 (strongly disagree) to 7 (strongly agree) (Webster et al., 2018).
Timepoint [1] 420998 0
During tablet onset (10 minutes after the tablet has been consumed).
Secondary outcome [2] 421857 0
Credibility: An adapted version of the Myers Credibility Index will assess the credibility of the information in the medication information sheet (Meyer, 1988). Participants rate the information in the medication information sheet on trust, accuracy, balance and credibility, using a 7-point scale ranging from 1 (Strongly disagree) to 7 (Strongly agree) (Meyer, 1988; Webster et al., 2018).
Timepoint [2] 421857 0
During tablet onset (10 minutes after the tablet has been consumed)
Secondary outcome [3] 421858 0
Usage: Participants will also be presented with two short statements to assess whether they reread the pamphlet after leaving their session and if they sought out other sources of information about the medication.
Timepoint [3] 421858 0
During tablet onset (10 minutes after tablet has been consumed)

Eligibility
Key inclusion criteria
Participants are eligible to take part in this study if they are 18 years or older, fluent in English, able to complete the questionnaires and willing to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are not eligible to participate in the study if they are taking medications that interact with Metoprolol (e.g. anti-hypertensives, anti-arrhythmics) or have any medical conditions in which beta-blockers should not be used (e.g. asthma or diabetes).


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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
12/07/2023
Actual
Date of last participant enrolment
Anticipated
4/08/2023
Actual
Date of last data collection
Anticipated
13/07/2023
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment outside Australia
Country [1] 25403 0
New Zealand
State/province [1] 25403 0
Auckland

Funding & Sponsors
Funding source category [1] 313683 0
University
Name [1] 313683 0
The University of Auckland
Country [1] 313683 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Road, Grafton, Auckland, New Zealand, 1023
Country
New Zealand
Secondary sponsor category [1] 315484 0
None
Name [1] 315484 0
Address [1] 315484 0
Country [1] 315484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312847 0
Auckland Health Research Ethics Committee (AHREC)
Ethics committee address [1] 312847 0
Ethics committee country [1] 312847 0
New Zealand
Date submitted for ethics approval [1] 312847 0
17/04/2023
Approval date [1] 312847 0
19/06/2023
Ethics approval number [1] 312847 0
Ref: 25740

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

Contacts
Principal investigator
Name 126130 0
Prof Keith Petrie
Address 126130 0
The University of Auckland
M&HS Building 507
Level 3, Room 320
85 Park Road, Grafton
Auckland 1023
Country 126130 0
New Zealand
Phone 126130 0
+64 9 923 6564
Fax 126130 0
Email 126130 0
[email protected]
Contact person for public queries
Name 126131 0
Keith Petrie
Address 126131 0
The University of Auckland
M&HS Building 507
Level 3, Room 320
85 Park Road, Grafton
Auckland 1023
Country 126131 0
New Zealand
Phone 126131 0
+64 9 923 6564
Fax 126131 0
Email 126131 0
[email protected]
Contact person for scientific queries
Name 126132 0
Keith Petrie
Address 126132 0
The University of Auckland
M&HS Building 507
Level 3, Room 320
85 Park Road, Grafton
Auckland 1023
Country 126132 0
New Zealand
Phone 126132 0
+64 9 923 6564
Fax 126132 0
Email 126132 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
We do not intend to share any identifiable data. Only the research team will have access to this information.


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.