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Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake

Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05542004
Acronym
NUDGE-FLU
Enrollment
964870
Registered
2022-09-15
Start date
2022-09-16
Completion date
2023-05-31
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior and Behavior Mechanisms, Influenza

Keywords

Influenza, Vaccination, Nudging, Behavioral Science

Brief summary

In randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. However, the real-world effectiveness of influenza vaccination is limited by its uptake. This study will investigate investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among eligible influenza vaccination candidates.

Detailed description

The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons identified as eligible for free-of-charge influenza vaccination in the Danish health system aged 18 years and above. Subjects will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10) and the Anatomical Therapeutic Chemical (ATC) classification system. Individuals will be randomized to 1 of 10 arms (1 control arm and 9 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries with the exception of information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms. The study will be performed in collaboration with the Danish Health Data Authority and Statens Serum Institut.

Interventions

The control arm will receive no letter to reflect the background vaccination uptake. Intervention arms will test the effects of different letters developed using behavioral economic principles.

Sponsors

Statens Serum Institut
CollaboratorOTHER
Sanofi Pasteur, a Sanofi Company
CollaboratorINDUSTRY
Tor Biering-Sørensen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Age \>=65 years at January 15, 2023 (eligible for free influenza vaccination in the official Danish vaccination program) 2. Access to the official, mandatory Danish electronic mailbox system

Exclusion criteria

1\) Persons living in nursing homes

Design outcomes

Primary

MeasureTime frame
Number of participants who received an influenza vaccineUp to 3 months

Secondary

MeasureTime frame
Time from intervention delivery to influenza vaccinationUp to 3 months

Other

MeasureTime frame
Number of participants with any hospitalizationUp to 8 months
All-cause mortalityUp to 8 months
Composite of incident heart failure, heart failure hospitalization, or cardiovascular deathUp to 8 months
Composite of myocardial infarction, stroke, or cardiovascular deathUp to 8 months
Composite of myocardial infarction, coronary revascularization, stroke, or cardiovascular deathUp to 8 months
Number of participants with incident heart failure or heart failure hospitalizationUp to 8 months
Cardiovascular deathUp to 8 months
Number of participants with laboratory-confirmed influenzaUp to 8 months
Number of participants with coronary revascularizationUp to 8 months
Number of participants with strokeUp to 8 months
Number of contacts to general practitioner (excluding vaccination visit)Up to 8 months
Number of participants with laboratory-confirmed COVID-19Up to 8 months
Number of participants with a hospitalization due to COVID-19Up to 8 months
Number of participants who received a COVID-19 vaccineUp to 3 months
Number of participants with myocardial infarctionUp to 8 months
Number of participants with a hospitalization with influenza or pneumoniaUp to 8 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026