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HealthyNCT03431012

Improving Communication During a Pandemic Flu Outbreak

A study testing Agency Assignment framing and Attribute framing in people with Healthy, run by King's College London.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

During the last pandemic influenza antivirals were prescribed both as prophylaxis and treatment. However, adherence rates were suboptimal. This study assessed the effect of theory-based and evidence-based health messages, which promoted the use of antivirals as prophylaxis for pandemic influenza, on intentions to use… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Agency Assignment framing and Attribute framing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
349 participants
Where
No sites listed yet
Study dates
26 May 2016to 8 Jun 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be eligible to participate, respondents had to be members of the UK general public in the adult age range (18-65 years), and be fluent in English.

Who cannot join

  • non-UK residents
  • younger than 18 or older than 65
  • not fluent in English

About this study

During the last pandemic influenza antivirals were prescribed both as prophylaxis and treatment. However, adherence rates were suboptimal. This study assessed the effect of theory-based and evidence-based health messages, which promoted the use of antivirals as prophylaxis for pandemic influenza, on intentions to use antivirals. Using hypothetical scenarios, the investigators tested whether written health communications about pandemic flu and recommended preventative medication (i.e. a prophylactic treatment with antivirals) had an effect on study participants' beliefs about the pandemic flu and the advice received, and their intention to adhere to the recommendation. In particular, the investigators assessed the behavioural impact of health messages presented in four different linguistic formats, defined by a 2×2 (agency assignment × attribute framing) factorial design. The originality of this study relies on the attempt to maximise the behavioural impact of written health messages by combining the agency assignment and attribute framings, which have never been tested together, and by systematically targeting specific predictors of adherence intentions through these messages. The findings of this study may be used to improve the behavioural impact of health communications to the general public in case of a pandemic flu outbreak in the UK.

Read the detailed description

Background: In 2009, a new strain of influenza virus, called pandemic influenza A(H1N1)pdm09, was detected in humans. During the pandemic in 2009/2010, antiviral medications were prescribed both as prophylaxis and treatment for influenza. However, many people, including those with chronic health conditions, did not used the antivirals as prescribed. This study focused on adherence to antivirals used as prophylaxis, as this is a key preventative stage before any vaccine can be available to the public. To ensure protection of public health during public health emergencies, such as pandemic flu, it is essential that the general public follow the health advice received. Therefore, future risk communications about the use of antivirals for pandemic influenza will need to address the barriers and facilitators of adherence.

This study investigated the effect of theory-based and evidence-based health messages, which promoted the use of antivirals as prophylaxis for pandemic influenza, on intentions to use antivirals. In particular, using hypothetical scenarios, the investigators tested whether written health communications about pandemic flu and recommended preventative medication (i.e. a prophylactic treatment with antivirals) had an effect on study participants' beliefs about the pandemic flu and the advice received, and their intention to adhere to the recommendation.

The linguistic manipulation used in the present study was based on an adaptation of a successful manipulation carried out by McGlone et al. (2013), who found that using the virus agency assignment in medical factsheets increased students' perception of susceptibility to and worry about the virus A/H1N1, perception of the severity of the consequences of catching the virus, perception of efficacy of the vaccine and reported intention to get the vaccine compared to the human agency assignment. The investigators wanted to test whether these results could be replicated in the context of taking antivirals for pandemic flu, using a more representative sample of the general population and controlling for baseline intentions.

For what concerns the framing of the side effects, research shows that the way information on medication side-effects is presented affects people's intentions to accept the recommended medications. The same side-effect likelihood can be expressed in a positively framed message (i.e. 90% of people will not develop side-effects) or in negatively framed message (i.e. 10% of people will develop side-effects). Although a previous meta-analysis (Moxey et al. 2003) found no significant framing effect on either actual immunization or behavioural intention, it found that positively framed information increased positive attitudes toward immunization and perception of the benefits of immunization, decreased expectation of side-effects and led to a more realistic understanding of the side-effects of influenza vaccines.

In addition, the health messages used in this study targeted specific variables, which have been in the past associated with higher adherence to antivirals for pandemic influenza. In particular, a recently published systematic review (Smith et al. 2016) investigated the factors affecting adherence to antivirals for influenza, including pandemic flu. They included 26 studies, of which 23 assessed pandemic influenza. Although many of the reviewed studies had serious methodological flaws, the review identified several psychosocial factors associated with adherence to antivirals prescribed as prophylaxis for pandemic flu. In particular, 11 studies investigated actual adherence to prophylactic antivirals. These studies showed that actual adherence was associated with previous adherence to other preventative measures for pandemic flu, beliefs that the recommended prophylactic measures were necessary and having discussed taking oseltamivir, a commonly used antiviral, with someone who had not experienced side effects. Although only one study found that the presence of side-effects was a significant predictor of non-adherence, the occurrence of side-effects was the most commonly self-reported reason for the discontinuation of oseltamivir. The review also included 8 studies investigating psychosocial predictors of intention to adhere: for instance, higher perceived susceptibility to the pandemic flu, higher perceived severity of pandemic flu, knowledge of pandemic flu, higher self-efficacy and response efficacy, and having previously accepted the flu vaccine were all associated with higher adherence intentions.

Methods: In May/June 2016 the investigated conducted an online experiment. After reading a hypothetical pandemic flu scenario, 349 adult UK residents were randomly allocated to one of four conditions, defined by a 2x2 (agency assignment × attribute framing of side effects) factorial design. Each condition presented messages describing the pandemic flu using linguistic expressions that assigned agency to either the humans (HA: human agency) or the virus itself (VA: virus agency), whilst describing the antivirals side effects in terms of the chances of either experiencing (NF: negative framing) or not experiencing side effects (PF: positive framing). Although presented with different framings the health messages provided equivalent information that targeted specific predictors of adherence. Participants were blinded to group assignment. Intentions to use the antivirals and potential mediating factors were measured. The aim was to understand the potential behavioural impact of the four health messages developed and to better understand the factors influencing adherence intentions.

Conditions
Healthy
Being tested
Agency Assignment framing, Attribute framing
Keywords
Adherence, medication, Pandemic Influenza
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Agency Assignment framingOther

    Also called Framing effect on behavioural intentions

    Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')

  • Attribute framingOther

    Also called Framing effect on behavioural intentions

    Linguistic framing used in written health messages. Each message described the side effects of the antivirals in terms of chances of either experiencing (negative framing: 'Uncommon side effects (10% of people will be affected)') or not experiencing side effects (positive framing: 'Uncommon side effects (90% of people will not be affected)') after using them.

Study groups in NCT03431012
Study groupRoleWhat they receive
Virus Agency/Negative Attribute FramingExperimentalParticipants in this condition, after reading a hypothetical scenario, received health messages describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing).
Receives: Other: Agency Assignment framing; Other: Attribute framing
Human Agency/Negative Attribute FramingExperimentalParticipants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of experiencing side effects after using them (Negative Framing health messages).
Receives: Other: Agency Assignment framing; Other: Attribute framing
Human Agency /Positive Attribute FramingExperimentalParticipants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to humans (Human Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).
Receives: Other: Agency Assignment framing; Other: Attribute framing
Virus Agency /Positive Attribute FramingExperimentalParticipants in this arm, after reading a hypothetical scenario, received a health message describing the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to the pandemic flu virus itself (Virus Agency Assignment framing), whilst describing the side effects of the antivirals in terms of chances of not experiencing side effects after using them (Positive Framing).
Receives: Other: Agency Assignment framing; Other: Attribute framing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Intentions to Take Antivirals for Pandemic Flu

    Mean adherence intentions post- exposure to the health information in the 4 groups. Intentions were measured by self-report items: participants were asked to agree with three statements about their intentions to take antivirals as recommended in the hypothetical scenario (on 9-point scale, where 1=strongly disagree to 9=strongly agree). The scores reported below represent a composite variable 'change in intentions', which reflects the average of the three items that compose it.

    Measured: Straight after exposure to the health messages

Secondary outcomes (6)
  1. Worry of the Pandemic Flu Threat

    Measured by self-report items adapted from Witte et al. (2001): participants were asked to agree with two statements about their perceived worry on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of reported worry about pandemic flu threat. This is a composite variable reflecting the average of the items that compose it.

    Measured: At 20 minutes (i.e. straight after exposure to the health messages)

  2. Perceived Susceptibility to the Pandemic Flu

    Measured by self-report items: participants were asked to state how likely they were to get sick with pandemic flu, had they not taken prophylactic medication o a 9-point scale, where 1=not likely at all, to 9=extremely likely.

    Measured: At 20 minutes (i.e. straight after exposure to the health messages)

  3. Perceived Severity of the Pandemic

    Measured by one self-report item (adapted from Witte et al. (2001): participants were asked to agree with a statement about their perception of the severity of the pandemic flu on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of perceived severity of the pandemic flu threat.

    Measured: At 20 minutes (i.e. straight after exposure to the health messages)

  4. Perceived Self-efficacy

    Measured by one self-report item (adapted from Witte et al. (2001): participants were asked to agree with a statement about their perceived ability to take the antivirals as recommended on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of reported self-efficacy.

    Measured: At 20 minutes (i.e. straight after exposure to the health messages)

  5. Perceived Efficacy of the Antivirals

    Measured by two self-report items (adapted from Godinho et al. (2016): participants were asked to agree with two statements about their perception of the efficacy of the antivirals against pandemic flu on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of perceived efficacy of the antivirals. This is a composite variable reflecting the average of the items that compose it.

    Measured: At 20 minutes (i.e. straight after exposure to the health messages)

  6. Perceived Response Costs

    Measured by self-report items adapted from Godinho et al. (2016): participants were asked to agree with four statements about their beliefs about the side effects and negative consequences of using antivirals on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of perceived response costs. This is a composite variable reflecting the average of the items that compose it.

    Measured: At 20 minutes (i.e. straight after exposure to the health messages)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2018
  2. Study start26 May 2016
  3. Primary completion8 Jun 2016
  4. Study completion8 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
This study was a vignette-based randomised controlled trial, with a 2 (human vs virus agency assignment) x 2 (negative vs positive frame of antivirals side effects) between-participants factorial design. All participants were presented with a hypothetical pandemic flu scenario describing moderate health consequences (i.e. about 1 in 1000 infected people dying). The scenario: 1) in the initial scenario participants were told to imagine that their GP (although not confirming whether it was a pandemic case) had advised them to take antivirals as a precaution; 2) after measuring baseline intentions, participants were introduced to the second part of the scenario where they were asked to imagine being at their local pharmacy where a pharmacist provided them with some health messages and information about the antivirals. Participants were randomised to one of the four health messages described below. After reading the health messages their intentions to use antivirals were re-measured.
Masking
Single blind
Who is masked
Participant
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03431012
Sponsor's protocol ID
LRS-15/16-2297
Status last verified
Jan 2018
First submitted
17 Jan 2018
Last updated
16 Dec 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McGlone MS, Bell RA, Zaitchik ST, McGlynn J 3rd. Don't let the flu catch you: agency assignment in printed educational materials about the H1N1 influenza virus. J Health Commun. 2013;18(6):740-56. doi: 10.1080/10810730.2012.727950. Epub 2012 Dec 5.

    PubMed 23216010
  • Moxey A, O'Connell D, McGettigan P, Henry D. Describing treatment effects to patients. J Gen Intern Med. 2003 Nov;18(11):948-59. doi: 10.1046/j.1525-1497.2003.20928.x.

    PubMed 14687282
  • Smith LE, D'Antoni D, Jain V, Pearce JM, Weinman J, Rubin GJ. A systematic review of factors affecting intended and actual adherence with antiviral medication as treatment or prophylaxis in seasonal and pandemic flu. Influenza Other Respir Viruses. 2016 Nov;10(6):462-478. doi: 10.1111/irv.12406. Epub 2016 Aug 8.

    PubMed 27397480

Questions about this trial

What is this clinical trial studying?

A study testing Agency Assignment framing and Attribute framing in people with Healthy, run by King's College London.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Intentions to Take Antivirals for Pandemic Flu (time frame: Straight after exposure to the health messages). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03431012, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.

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Improving Communication During a Pandemic Flu Outbreak | AzTrials