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Trial registered on ANZCTR


Registration number
ACTRN12616001393448p
Ethics application status
Not yet submitted
Date submitted
5/10/2016
Date registered
7/10/2016
Date last updated
7/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
What’s in a name: a study protocol for a randomised controlled trial to identify the influence of diagnostic labels for mild depression and acute bronchitis on intended medication use.
Scientific title
What’s in a name: a study protocol for a randomised controlled trial to identify the influence of diagnostic labels for mild depression and acute bronchitis on intended medication use.
Secondary ID [1] 290239 0
Nil known
Universal Trial Number (UTN)
U1111-1188-1151
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 300430 0
Acute Bronchitis 300431 0
Overdiagnosis 300432 0
Condition category
Condition code
Mental Health 300294 300294 0 0
Depression
Respiratory 300296 300296 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be presented with one of four case scenarios. Case scenarios (which include the label) will be presented via a web-based survey using the online survey platform Qualtrics. Following randomisation to either “mild depression” or “acute bronchitis”, participants will receive either a scenario with a “diagnostic label' (e.g. "mild depression" or "acute bronchitis") or “symptomatic label" (e.g "the symptoms you are experiencing"). All scenarios: (1) describe symptoms of the allocated condition; (2) offer medication as a treatment option (i.e. SSRIs for “mild depression” and antibiotics for “acute bronchitis”); and (3) contain evidence-based information on the potential harms and benefits of medications for the relevant condition.
The time required to complete the scenario and assessment is approximately 10 minutes.
Intervention code [1] 296019 0
Other interventions
Comparator / control treatment
Symptomatic label group
Control group
Active

Outcomes
Primary outcome [1] 299770 0
Participants' intention to take the proposed medication (i.e. SSRIs or antibiotics). This will be assessed on a 4-Point Likert scale from "Definitely wouldn't take" to "Definitely would take".
Timepoint [1] 299770 0
The outcome will be assessed immediately after reading the scenario information.
Secondary outcome [1] 328072 0
Why participants made the decision they did. This will be assessed using the following open-ended questions: 1) Why did you make this decision; and, 2) Which part(s) of the scenario most influenced your decision.
Timepoint [1] 328072 0
The outcome will be assessed following presentation of the case scenario and related question.

Eligibility
Key inclusion criteria
We will recruit adults who can understand written English and provide informed consent, and who live in one of three English speaking, developed countries that have fee-for-service healthcare environments (Australia, Ireland, and Canada) and do not have direct consumer advertising.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
We will exclude those with current depression or acute bronchitis.

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)
Computerized randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized 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
Stratified by diagnosis
Following randomisation to either “mild depression” or “acute bronchitis”, participants will receive either a scenario with a “diagnostic label” or “symptomatic label.”
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will analyse dichotomised data using Chi squared analysis. We will also look at a subgroup analysis by country of origin. We will also do an adjusted analysis adjusting for gender, age, educational level and previous history of the condition. Open-ended questions will be analysed using content analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8276 0
Ireland
State/province [1] 8276 0
Country [2] 8277 0
Canada
State/province [2] 8277 0

Funding & Sponsors
Funding source category [1] 294603 0
University
Name [1] 294603 0
Bond University
Country [1] 294603 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Drive, Robina, QLD 4226
Country
Australia
Secondary sponsor category [1] 293467 0
None
Name [1] 293467 0
Address [1] 293467 0
Country [1] 293467 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296047 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 296047 0
Ethics committee country [1] 296047 0
Australia
Date submitted for ethics approval [1] 296047 0
07/10/2016
Approval date [1] 296047 0
Ethics approval number [1] 296047 0

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

Contacts
Principal investigator
Name 69346 0
Dr Amanda McCullough
Address 69346 0
Centre for Research in Evidence Based Practice
14 University Dr, Robina, QLD 4226
Country 69346 0
Australia
Phone 69346 0
+61 (7) 5595 5204
Fax 69346 0
Email 69346 0
[email protected]
Contact person for public queries
Name 69347 0
Amanda McCullough
Address 69347 0
Centre for Research in Evidence Based Practice
14 University Dr, Robina, QLD 4226
Country 69347 0
Australia
Phone 69347 0
+61 (7) 5595 5204
Fax 69347 0
Email 69347 0
[email protected]
Contact person for scientific queries
Name 69348 0
Amanda McCullough
Address 69348 0
Centre for Research in Evidence Based Practice
14 University Dr, Robina, QLD 4226
Country 69348 0
Australia
Phone 69348 0
+61 (7) 5595 5204
Fax 69348 0
Email 69348 0
[email protected]

No information has been provided regarding IPD availability


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.