ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001700224

Ethics application status

Approved

Date submitted

9/10/2018

Date registered

16/10/2018

Date last updated

1/07/2019

Date data sharing statement initially provided

29/11/2018

Date results information initially provided

27/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

How doctors' language impacts peoples' understanding and decision making about cardiovascular risk

Scientific title

Randomised comparison of the impact of different terminologies and labelling for hypertension on severity perception and willingness to accept treatment

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

hypertension

cardiovascular disease

Condition category

Condition code

Public Health

Other public health

Cardiovascular

Hypertension

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This experimental study seeks to investigate the effect of different labels for high blood pressure (hypertension vs high normal blood pressure) on treatment decision-making and psychosocial outcomes (perceived severity; level of concern), compared to a control group where no label is given. It will also explore whether any effect is affected by a) sharing absolute risk information and b) health literacy.

The intervention will be delivered via an online survey to each participant which they can complete on any computer at their convenience during the study period. Website analytics will be used to monitor completion rates to monitor adherence to the study.

Each participant will read a hypothetical diagnosis based on the group to which they have been randomised and complete a questionnaire based on this information (anticipated time to complete the survey is approximately 15minutes).

Survey participants will be randomised into one of three groups receiving a different hypothetical diagnosis from a clinician, either the ‘hypertension label’ arm, ‘high normal blood pressure’ arm and a ‘control’ arm given no label. Within each arm of the study they will be randomised to one of two sub groups, receiving either an ‘absolute risk description’ or no further information.

HYPERTENSION LABEL STUDY ARM HYPOTHETICAL
You are at your doctor (GP) for a check-up. The doctor has taken your blood pressure a few times recently and says:
Your blood pressure readings are 135/ 85 and that means you have hypertension.

*Absolute risk description provided to half of the study arm through randomisation:
Hypertension can increase your risk of heart disease. Combining your current blood pressure reading with your other risk factors means your overall risk of a heart attack or stroke in the next 10 years is low (that is, you have less than 10% risk of a heart attack or stroke)

HIGH NORMAL BP LABEL STUDY ARM HYPOTHETICAL:
You are at your doctor (GP) for a check-up. The doctor has taken your blood pressure a few times recently and says:
Your blood pressure readings are 135/ 85 and that means you have high normal blood pressure.

*Absolute risk description provided to half of the study arm through randomisation:
High blood pressure can increase your risk of heart disease. Combining your current blood pressure reading with your other risk factors means your overall risk of a heart attack or stroke in the next 10 years is low (that is, you have less than 10% risk of a heart attack or stroke)

Intervention code [1]

Prevention

Comparator / control treatment

Survey participants randomised into the control arm of the study will be shown hypothetical blood pressure reading information with no diagnosis label provided and given either absolute risk information related to this blood pressure reading or no further information.

NO LABEL (ABSOLUTE RISK) CONTROL STUDY ARM HYPOTHETICAL:
You are at your doctor (GP) for a check-up. The doctor has taken your blood pressure a few times recently and says:
Your blood pressure readings are 135/ 85. This blood pressure is close to the average blood pressure for someone your age, but a little higher.

*Absolute risk description provided to half of the study arm through randomisation:
High blood pressure can increase your risk of heart disease. Combining your current blood pressure reading with your other risk factors means your overall risk of a heart attack or stroke in the next 10 years is low (that is, you have less than 10% risk of a heart attack or stroke)

Control group

Active

Outcomes

Primary outcome [1]

Willingness to accept treatment (lifestyle)

Questionnaire includes questions specifically designed for this study testing willingness informed using measures previously validated and published in research testing the impact of diagnosis labelling, particularly Copp (2017) and Scherer (2013).

References:
Copp, T., McCaffery, K., Azizi, L., Doust, J., Mol, B., & Jansen, J. (2017). 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, 32(4), 876-884.

Scherer, L. D., Zikmund-Fisher, B. J., Fagerlin, A., & Tarini, B. A. (2013). Influence of "GERD" label on parents' decision to medicate infants. Pediatrics, 131(5), 839-845.

Timepoint [1]

At time of questionnaire completion

Primary outcome [2]

Perception of severity or level of concern.

This is a composite primary outcome. Measures on perceptions of the hypothetical diagnoses have been developed from the Illness Perception Questionnaire and informed by the Positive and Negative Affect Schedule (PANAS)

References for the IPQ and PANAS:
Broadbent, E., Petrie, K. J., Main, J., & Weinman, J. (2006). The brief illness perception questionnaire. Journal of Psychosomatic Research, 60(6), 631-637.

Thompson, E. R. (2007). Development and validation of an internationally reliable short-form of the positive and negative affect schedule (PANAS). Journal of Cross-Cultural Psychology, 38(2), 227-242.

Timepoint [2]

At time of questionnaire completion

Primary outcome [3]

Willingness to accept treatment (medication)

Questionnaire includes questions specifically designed for this study testing willingness informed using measures previously validated and published in research testing the impact of diagnosis labelling, particularly Copp (2017) and Scherer (2013).

References:
Copp, T., McCaffery, K., Azizi, L., Doust, J., Mol, B., & Jansen, J. (2017). 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, 32(4), 876-884.

Scherer, L. D., Zikmund-Fisher, B. J., Fagerlin, A., & Tarini, B. A. (2013). Influence of "GERD" label on parents' decision to medicate infants. Pediatrics, 131(5), 839-845.

Timepoint [3]

At time of questionnaire completion

Secondary outcome [1]

Does hypertension labelling impact on a person’s plan to manage their health?

Questionnaire includes questions specifically designed for this study testing plans to manage health informed using measures previously validated and published in research testing the impact of diagnosis labelling, particularly Copp (2017) and Scherer (2013).

References:
Copp, T., McCaffery, K., Azizi, L., Doust, J., Mol, B., & Jansen, J. (2017). 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, 32(4), 876-884.

Scherer, L. D., Zikmund-Fisher, B. J., Fagerlin, A., & Tarini, B. A. (2013). Influence of "GERD" label on parents' decision to medicate infants. Pediatrics, 131(5), 839-845.

Timepoint [1]

At time of questionnaire completion

Eligibility

Key inclusion criteria

People aged 40-50

Minimum age

40 Years

Maximum age

50 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participant has been diagnosed with: heart disease, hypercholesterolaemia, high blood pressure, kidney disease or diabetes

Smokers

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)

Researchers will have no direct contact with participants. Participants will be enrolled into the study via independent recruitment provider Research Now SSI and provided with a link to complete a survey via Qualtrics. Participants will be randomised via the qualtrics software.

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

Qualtrics computer software will randomly allocate each participant to one of the arms of the trial as they enter the study.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data will be collected via a survey and deidentified. Survey participants will be randomised into one of three hypothetical groups, either the ‘hypertension label’ arm, ‘high normal blood pressure’ arm and a ‘control’ arm given no label. Within each arm of the study they will be randomised to one of two sub groups, receiving either an ‘absolute risk description’ or no further information. This will allow analysis across four sub groups of the study (214 randomised to each of four groups within the survey of 1284 participants)

Logistic regression will be used to analyse the primary categorical outcome (i.e., more willing to accept medication vs. more willing to make lifestyle changes), and multiple linear regression for primary continuous outcomes (severity and concern), with label (medicalised; lay; no label) and absolute risk (provided; not provided) included as categorical study factors in both models. The use of regression modelling will allow for control of any baseline differences in demographics between randomised groups, if required.
A similar regression modelling approach will be used for the secondary outcomes (logistic models for categorical outcomes; linear models for continuous outcomes). Potential effect modification by health literacy (as NVS) will be examined by inclusion of an interaction term between health literacy and the study factors in relevant models. Similarly, inclusion of an interaction term of the two study factors will be included to determine if the provision of absolute risk information modifies the effect of labelling on the primary outcomes.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/02/2019

Actual

5/02/2019

Date of last participant enrolment

Anticipated

18/02/2019

Actual

1/04/2019

Date of last data collection

Anticipated

18/02/2019

Actual

1/04/2019

Sample size

Target

1284

Accrual to date

Final

1301

Recruitment in Australia

Recruitment state(s)

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

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Sydney

Address [1]

School of Public Health
Edward Ford Building A27
The University of Sydney
NSW
2006

Country [1]

Australia

Primary sponsor type

University

Name

School of Public Health, University of Sydney

Address

School of Public Health
Edward Ford Building A27
The University of Sydney
NSW
2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Research Integrity and Ethics Administration | Research Portfolio
THE UNIVERSITY OF SYDNEY
Level 3, Administration Building (F23) | The University of Sydney | NSW | 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/09/2018

Approval date [1]

07/11/2018

Ethics approval number [1]

2018/828

Summary

Brief summary

This experimental study seeks to investigate the effect of different labels for high blood pressure (e.g. hypertension vs high normal blood pressure) on treatment decision-making and psychosocial outcomes (perceived severity; level of concern), compared to a control group where no label is given. It will also explore whether any effect is affected by a) sharing absolute risk information and b) health literacy.

Australian adults aged 40-50 with a normal risk of hypertension will be sampled. Only those with an average risk profile will be included in the study, to be presented with a hypothetical diagnosis and asked a number of survey questions investigating health literacy, treatment decision making, risk perception and perceived self-efficacy.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Kirsten McCaffery

Address

The University of Sydney
Rm 128B, Edward Ford Building A27
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 9351 7220

Fax

[email protected]

Contact person for public queries

Name

Prof Kirsten McCaffery

Address

The University of Sydney
Rm 128B, Edward Ford Building A27
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 9351 7220

Fax

[email protected]

Contact person for scientific queries

Name

Prof Kirsten McCaffery

Address

The University of Sydney
Rm 128B, Edward Ford Building A27
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 9351 7220

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

only de-identified data will be available

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
374	Ethical approval

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Benefits and Harms of Hypertension and High-Normal Labels: A Randomized Experiment.	2021	https://dx.doi.org/10.1161/CIRCOUTCOMES.120.007160

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

Trial Review

Documents added manually

Documents added automatically