Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults

Influenza Clinical Trial

— NUDGE-FLU-2  

Official title:

Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06030726
• Other study ID #: NUDGE-FLU-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2024
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• 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. Conducted during the 2022/2023 influenza season, the first NUDGE-FLU trial demonstrated the effectiveness of two electronic behavioral nudging letter strategies in increasing influenza vaccination rates among older adults in Denmark - a letter highlighting potential cardiovascular benefits of vaccination and a standard informational letter sent at baseline and repeated at day 14. This present study will once again investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among older adults including whether the effectiveness of previously successful strategies can be confirmed during a subsequent influenza season.

Description:

The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons aged >=65 years at January 15, 2024 - this age group is eligible for free-of-charge influenza vaccination in the official Danish vaccination program. Subjects will be identified through Danish nationwide health registries including the Danish Civil Registration System. Individuals will be randomized to 1 of 7 arms (1 usual care arm and 6 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 881373
• Est. completion date: May 31, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Age >=65 years at January 15, 2024 (eligible for free-of-charge influenza vaccination in the Danish public health system)

2. Access to the official, mandatory Danish electronic mailbox system

Exclusion Criteria:

1. Persons living in nursing homes (approximated as any person living at an address with >=6 inhabitants aged 80 years and above)

2. Known to have already scheduled influenza vaccination appointment

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms
• Influenza
• Influenza, Human

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 (1)

Lead Sponsor	Collaborator
Tor Biering-Sørensen

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 for influenza or pneumonia		Up to 8 months
Other	Number of participants with a hospitalization for any respiratory disease		Up to 8 months
Other	Number of participants with a hospitalization for any cardio-respiratory disease		Up to 8 months
Other	Number of participants with a hospitalization for any cardiovascular disease		Up to 8 months
Other	Number of participants with any hospitalization		Up to 8 months
Other	Total number of hospitalizations (first and recurrent)		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	Total number of heart failure events (incident heart failure and first and recurrent heart failure hospitalizations)		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 participants with incident atrial fibrillation or atrial fibrillation hospitalization		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 for COVID-19		Up to 8 months
Other	Number of participants who received a COVID-19 vaccine		Up to 3 months
Other	Number of participants who filled a prescription for any guideline-directed medical therapy for heart failure		Up to 8 months
Other	Total number of filled prescriptions for guideline-directed medical therapy for heart failure		Up to 8 months
Other	Number of participants who filled a prescription for a sodium-glucose cotransporter 2 inhibitor or glucagon-like peptide 1 receptor agonist		Up to 8 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