NCT03431012

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2016

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 16, 2019

Completed
Last Updated

December 16, 2019

Status Verified

January 1, 2018

Enrollment Period

13 days

First QC Date

January 17, 2018

Results QC Date

September 23, 2019

Last Update Submit

November 21, 2019

Conditions

Keywords

Adherence, medicationPandemic Influenza

Outcome Measures

Primary Outcomes (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.

    Straight after exposure to the health messages

Secondary Outcomes (6)

  • Worry of the Pandemic Flu Threat

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

  • Perceived Susceptibility to the Pandemic Flu

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

  • Perceived Severity of the Pandemic

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

  • Perceived Self-efficacy

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

  • Perceived Efficacy of the Antivirals

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

  • +1 more secondary outcomes

Study Arms (4)

Virus Agency/Negative Attribute Framing

EXPERIMENTAL

Participants 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).

Other: Agency Assignment framingOther: Attribute framing

Human Agency/Negative Attribute Framing

EXPERIMENTAL

Participants 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).

Other: Agency Assignment framingOther: Attribute framing

Human Agency /Positive Attribute Framing

EXPERIMENTAL

Participants 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).

Other: Agency Assignment framingOther: Attribute framing

Virus Agency /Positive Attribute Framing

EXPERIMENTAL

Participants 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).

Other: Agency Assignment framingOther: Attribute framing

Interventions

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…')

Also known as: Framing effect on behavioural intentions
Human Agency /Positive Attribute FramingHuman Agency/Negative Attribute FramingVirus Agency /Positive Attribute FramingVirus Agency/Negative Attribute Framing

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.

Also known as: Framing effect on behavioural intentions
Human Agency /Positive Attribute FramingHuman Agency/Negative Attribute FramingVirus Agency /Positive Attribute FramingVirus Agency/Negative Attribute Framing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 23216010BACKGROUND
  • 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.

    PMID: 14687282BACKGROUND
  • 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.

    PMID: 27397480BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr D D'Antoni
Organization
KCL

Study Officials

  • Donatella D'Antoni

    King's College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to group assignment.
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 13, 2018

Study Start

May 26, 2016

Primary Completion

June 8, 2016

Study Completion

June 8, 2016

Last Updated

December 16, 2019

Results First Posted

December 16, 2019

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share