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Trial registered on ANZCTR

Registration number

ACTRN12618000392268

Ethics application status

Approved

Date submitted

14/02/2018

Date registered

16/03/2018

Date last updated

16/03/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

How health labels affect behavioural intentions and perceptions of illnesses.

Scientific title

How health labels affect behavioural intentions and perceptions of illnesses in adults.

Secondary ID [1]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Kidney disease Stage 3A

Pre-diabetes

Mild Hyperlipidaemia

Mild Hypertension

Condition category

Condition code

Public Health

Other public health

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

We will conduct a single, on-line survey. Participants will be randomised to read either “labelled” or “description only” hypothetical scenarios. Scenarios describe the outcome of a recent health test using either the medical terms (label scenario) or descriptive terms (descriptive only scenario). There are both “labelled” and “descriptive only” scenarios for four health condition (pre-diabetes, mild hypertension, mild hyperlipidaemia, and chronic kidney disease stage 3a). Participants will read a random selection for two of the four scenarios in each category (labelled or description only), balanced to ensure even distribution of scenarios across participants. After reading the scenarios, participants will be asked to rate the likelihood of attending follow-up tests for the specific condition (either blood glucose level, kidney function, blood pressure or cholesterol). The survey is expected to take up to 20 minutes.

Intervention code [1]

Behaviour

Comparator / control treatment

Each participant will be randomized to read and respond to two of four "labelled" scenarios or "descriptive only" scenarios. The health conditions will be pre-diabetes, mild hypertension, mild hyperlipidaemia, chronic kidney disease 3A.

Control group

Active

Outcomes

Primary outcome [1]

Differences in intention to undertake further tests between labelled and description only scenarios will be analysed from participant responses to the question "Which best describes your intention to have the follow-up tests described in the scenario next week?" Response options range from 1 (definitely will not) to 10 (definitely will).

Timepoint [1]

end of survey

Secondary outcome [1]

Differences in confidence in participant’s decision to undertake further tests between labelled and description only scenarios will be analysed from participant responses to the questions "How confident are you with your decision in the above scenario?" Response options range from 1 (definitely will not) to 10 (definitely will).

Timepoint [1]

end of survey

Secondary outcome [2]

The effects of participant characteristics on intention to undertake further tests will be assessed using multivariate regression analysis.
The participant characteristics that will be assessed are:
• Personality (scale from Gosling et al, 2003)
• Health locus of control (scale from Wallston, Wallston & DeVellis, 1978)
• Regulatory focus (scale from Haws, Dholakia & Bearden, 2010)
• Medical minimiser/maximiser (scale from Scherer et al 2016)
• Risk orientation (scale adapted from Weber et al. 2002)
• Risk perceptions (scale adapted from Fox-Glassman & Weber 2006, Barnett & Breakwell 2001, Slovic 2001)
• Stigma (scale adapted from Brakel 2006 )

Timepoint [2]

end of survey

Secondary outcome [3]

Risk perception scores for labelled and description only conditions will be determined. Scale is comprised of items from Fox-Glassman & Weber 2006, Barnett & Breakwell 2001, Slovic 2001 .

Timepoint [3]

end of survey

Secondary outcome [4]

Differences in satisfaction in participant’s decision to undertake further tests between labelled and description only scenarios will be analysed from participant responses to the question "How satisfied are you with your decision in the above scenario?" Response options range from 1 (definitely will not) to 10 (definitely will).

Timepoint [4]

end of survey

Eligibility

Key inclusion criteria

General population from Australia, Canada and Ireland using a convenience sample of participants registered with the survey company Qualtrix

Minimum age

45 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

<45 years

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Computer generated randomisation to either "labelled" or "description only" scenarios. The researchers have no direct contact with survey participants.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Qualtrix algorithm

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

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Data from a previous study comparing label and descriptive only scenarios reported a statistically significant between group difference of 0.86, SD 2.7 (Copp et al, 2017), however, we consider a 1-point difference in the 10-point future intentions to test scale to be the smallest clinically meaningful difference. With probability set at 0.8 and statistical significance set to p=0.05, our power calculation suggests we will need 115 participants per group (230 total). To ensure equal numbers from each country, the sample will be 240 (80 per country).
Primary analysis –We will analyse differences in intention to undertake further tests between labelled and description only scenarios using t-tests.
Secondary analyses – We will conduct 4 secondary analyses. First, using t-tests, we will report differences in satisfaction and confidence in participant’s decision to undertake further tests between labelled and description only scenarios. Second, we will also conduct simple linear regression with each variable including demographics. Levels of significance will be set at p=0.1. Significant variables from the linear regression will then be included in a series of multivariate regression analyses, where the personality characteristic measures noted above are layered in to assess their effect on the dependent variables intentions to pursue follow-on tests, satisfaction and confidence. Third, we will conduct exploratory analysis of whether intentions to pursue follow on tests (as well as satisfaction and confidence in decision) differ by illness condition as well as by label versus description only. These are considered exploratory given the smaller sample sizes at the individual illness level. Finally, we will produce a perceptual map of illnesses by label condition (eight illness by label combinations) based on subjects’ responses to six risk perception measures. Each subject rates two illness conditions on six risk perception measures. These six risk perception measures are factor analysed to reduce to two or three dimensions. The factor loadings can then be used to create a perceptual map of the eight illness by label combinations (Fox-Glassman & Weber, 2016).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

20/03/2018

Actual

Date of last participant enrolment

Anticipated

20/04/2018

Actual

Date of last data collection

Anticipated

20/04/2018

Actual

Sample size

Target

240

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

Canada

State/province [1]

Country [2]

Ireland

State/province [2]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Bond University

Address [1]

1 University Drv
Robina,
Australia, 4229

Country [1]

Australia

Primary sponsor type

University

Name

Bond University

Address

1 University Drv
Robina,
Australia, 4229

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human research Ethics Committee

Ethics committee address [1]

1 University Drv
Robina
Australia, 4229

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/07/2017

Approval date [1]

31/01/2018

Ethics approval number [1]

RO0016123

Summary

Brief summary

How clinicians describe a health problem influences the health decisions of patients. A recent systematic review (Nickel, et al., 2017) identified seven studies that provided participants with hypothetical scenarios that described health conditions. Each condition was described using two or more differing terminologies (medicalised or descriptive). For example, when a participant read a hypothetical scenario about polycystic ovary syndrome (PCOS), when the participant was given the name of the health condition (PCOS) compared with the description of a ‘hormonal imbalance’, they were more likely to have an ultrasound (Copp et al., 2017), or when told in the scenario their child had Gastro-oesophageal reflux compared with only a description of symptoms, participants had greater intention to treat the condition with medication (Scherer et al., 2013). 
These studies share several characteristics: subjects were young women, scenarios were hypothetical, and both investigated a single illness potentially prone to overdiagnosis. But they can only speculate on possible cognitive processes driving subjects’ decisions because they lack mechanisms to formally test possible psychological factors driving the changes in intentions. 
Using four hypothetical health conditions (each with a diagnostic labelled version and a description only version) we will analyse between group differences of participants intentions to undertake further tests. We will also report differences in satisfaction and confidence in decision making and explore the effects of participant characteristics (personality, health locus of control, regulatory focus, medical minimiser/maximiser), risk orientation, risk perceptions and stigma on intention to undertake further tests. 
Drawing from the extensive body of research on ‘perceptions of risk’ (Slovic 2000) and stigma (Brakel 2006), we will also explore differences in perceptions of risk between labelled and description only scenarios for each of four illnesses. Finally, we will conduct exploratory analysis of whether intentions to pursue follow on tests (as well as satisfaction and confidence in decision) differ by illness condition as well as by label versus description only.
References:
Nickel B, Barratt A, Copp T, Mynihan R, McCaffery K. Words do matter: a systematic review on how different terminologies for the same condition influences management preferences. BMJ Open 2017
Copp T, McCaffery K, Azizi L, Doust J, Mol BWJ, Jansen J. Influence of the disease label ‘polycystic ovary syndrome’ on intention to have an ultrasound and psychosocial outcomes: a randomised online study in young women. Human Reproduction 2017
Scherer LD, Zikmund-Fisher BJ, Fagerlin A, Tarini BA. Influence of “GERD” label on parents’ decision to medicate infants. Pediatrics 2013
Slovic P. (2000) The Perception of Risk. 
Brakel WH. Measuring health-related stigma – A review of the literature.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Rae Thomas

Address

Centre for Research in Evidence-Based Practice
Faculty of Health Sciences and Medicine
Bond University
1 University Drv
Robina, 4229

Country

Australia

Phone

+61 7 5595 5561

Fax

rthomas@bond.edu.au

Contact person for public queries

Name

Rae Thomas

Address

Centre for Research in Evidence-Based Practice
Faculty of Health Sciences and Medicine
Bond University
1 University Drv
Robina, 4229

Country

Australia

Phone

+61 7 5595 5561

Fax

rthomas@bond.edu.au

Contact person for scientific queries

Name

Rae Thomas

Address

Centre for Research in Evidence-Based Practice
Faculty of Health Sciences and Medicine
Bond University
1 University Drv
Robina, 4229

Country

Australia

Phone

+61 7 5595 5521

Fax

rthomas@bond.edu.au

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		We examined the effect of ‘labels’ versus ‘descrip... [More Details]
Study results article	Yes		Thomas R, Spence MT, Roy R, Beller E (2020) A rand... [More Details]	374169-(Uploaded-19-02-2021-12-46-18)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A randomised on-line survey exploring how health condition labels affect behavioural intentions.	2020	https://dx.doi.org/10.1371/journal.pone.0240985

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added automatically