NCT03431012

Improving Communication During a Pandemic Flu Outbreak

Completed NA Results posted Last updated 16 December 2019

What this trial tests

NA trial testing Agency Assignment framing in Healthy in 349 participants. Completed in 8 June 2016.

Timeline

26 May 2016

Primary endpoint
8 June 2016

8 June 2016

Quick facts

Lead sponsor	King's College London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	prevention
Enrollment	349
Start date	26 May 2016
Primary completion	8 June 2016
Estimated completion	8 June 2016

Drugs / interventions tested

• Agency Assignment framing
• Attribute framing

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

King's College London

Who can join

Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Intentions to Take Antivirals for Pandemic Flu Primary · Straight after exposure to the health messages

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.

Group	Value	95% CI
Virus Agency/Negative Attribute Framing	8.29	± 0.12
Human Agency/Negative Attribute Framing	8.16	± 0.12
Human Agency /Positive Attribute Framing	8.23	± 0.12
Virus Agency /Positive Attribute Framing	8.35	± 0.11

Worry of the Pandemic Flu Threat Secondary · At 20 minutes (i.e. straight after exposure to the health messages)

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.

Group	Value	95% CI
Human Agency	6.06	± 0.19
Virus Agency	6.50	± 0.20

Perceived Susceptibility to the Pandemic Flu Secondary · At 20 minutes (i.e. straight after exposure to the health messages)

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.

Group	Value	95% CI
Human Agency	6.32	± 0.14
Virus Agency	6.37	± 0.15

Perceived Severity of the Pandemic Secondary · At 20 minutes (i.e. straight after exposure to the health messages)

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.

Group	Value	95% CI
Human Agency	5.92	± 0.19
Virus Agency	6.59	± 0.21

Perceived Self-efficacy Secondary · At 20 minutes (i.e. straight after exposure to the health messages)

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.

Group	Value	95% CI
Human Agency	8.23	± 0.12
Virus Agency	8.45	± 0.13

Perceived Efficacy of the Antivirals Secondary · At 20 minutes (i.e. straight after exposure to the health messages)

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.

Group	Value	95% CI
Negative Framing	6.45	± 0.15
Positive Framing	6.59	± 0.14

Perceived Response Costs Secondary · At 20 minutes (i.e. straight after exposure to the health messages)

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.

Group	Value	95% CI
Negative Framing	3.53	± 0.17
Positive Framing	3.70	± 0.17

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.