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NCT05542004 Clinical Trial

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

Influenza Clinical Trial

— NUDGE-FLU  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05542004
Other study ID # FLU00180
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2022
Est. completion date May 31, 2023

Study information
Verified date June 2023
Source Herlev and Gentofte Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 964870
Est. completion date May 31, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Behavioral Economic Principles
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.

Locations
Country Name City State
Denmark Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte Hellerup Hovedstaden

Sponsors (3)
Lead Sponsor Collaborator
Tor Biering-Sørensen Sanofi Pasteur, a Sanofi Company, Statens Serum Institut

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Number of participants with laboratory-confirmed influenza Up to 8 months
Other Number of participants with a hospitalization with influenza or pneumonia Up to 8 months
Other Number of participants with any hospitalization Up to 8 months
Other All-cause mortality Up to 8 months
Other Composite of incident heart failure, heart failure hospitalization, or cardiovascular death Up to 8 months
Other Composite of myocardial infarction, stroke, or cardiovascular death Up to 8 months
Other Composite of myocardial infarction, coronary revascularization, stroke, or cardiovascular death Up to 8 months
Other Number of participants with incident heart failure or heart failure hospitalization Up to 8 months
Other Cardiovascular death Up to 8 months
Other Number of participants with myocardial infarction Up to 8 months
Other Number of participants with coronary revascularization Up to 8 months
Other Number of participants with stroke Up to 8 months
Other Number of contacts to general practitioner (excluding vaccination visit) Up to 8 months
Other Number of participants with laboratory-confirmed COVID-19 Up to 8 months
Other Number of participants with a hospitalization due to COVID-19 Up to 8 months
Other Number of participants who received a COVID-19 vaccine Up to 3 months
Primary Number of participants who received an influenza vaccine Up to 3 months
Secondary Time from intervention delivery to influenza vaccination Up to 3 months
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