Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616001393448 |
Date of registration:
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07/10/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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. |
Date of first enrolment:
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31/10/2016 |
Target sample size:
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1600 |
Recruitment status: |
Not yet recruiting |
URL:
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https://anzctr.org.au/ACTRN12616001393448.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Canada
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Ireland
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Contacts
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Name:
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Dr Amanda McCullough
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Address:
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Centre for Research in Evidence Based Practice
14 University Dr, Robina, QLD 4226
Australia |
Telephone:
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+61 (7) 5595 5204 |
Email:
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amccullo@bond.edu.au |
Affiliation:
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Name:
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Dr Amanda McCullough
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Address:
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Centre for Research in Evidence Based Practice
14 University Dr, Robina, QLD 4226
Australia |
Telephone:
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+61 (7) 5595 5204 |
Email:
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amccullo@bond.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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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.
Exclusion criteria: We will exclude those with current depression or acute bronchitis.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Respiratory - Other respiratory disorders / diseases
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Depression;Acute Bronchitis;Overdiagnosis; Depression Acute Bronchitis Overdiagnosis
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Mental Health - Depression
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Intervention(s)
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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.
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Primary Outcome(s)
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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".[The outcome will be assessed immediately after reading the scenario information.]
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Secondary Outcome(s)
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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. [The outcome will be assessed following presentation of the case scenario and related question.]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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Bond University
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Ethics review
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Status: Not approved
Approval date:
Contact:
Bond University Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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