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

NCT ID: NCT06030726

Last Updated: 2024-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

881373 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-14

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Influenza Behavior and Behavior Mechanisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Usual Care

No letter

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard Letter

This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Repeated Letter

The standard letter sent out two times instead of once

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Cardiovascular Gain-Framing Letter

Text added to the standard letter highlighting potential cardiovascular benefits of influenza vaccination

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Respiratory Gain-Framing Letter

Text added to the standard letter highlighting potential respiratory disease-related benefits of influenza vaccination

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Implementation Intention Prompt Letter

Implementation intention prompt added to the standard letter

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Loss-Framing Letter

Text added to the standard letter highlighting potential risks of not receiving influenza vaccination

Group Type EXPERIMENTAL

Behavioral Economic Principles

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tor Biering-Sørensen

OTHER

Sponsor Role lead

Responsible Party

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Tor Biering-Sørensen

Professor, MD, MSc, MPH, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tor Biering-Sørensen, MD, MSc, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Locations

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Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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Bhatt AS, Johansen ND, Vaduganathan M, Modin D, Pareek M, Chatur S, Claggett BL, Janstrup KH, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Dueger EL, Samson S, Loiacono MM, Harris RC, Kober L, Solomon SD, Martel CJ, Sivapalan P, Jensen JUS, Biering-Sorensen T. Electronic Nudges and Influenza Vaccination Among Patients With a History of Myocardial Infarction: Insights From 3 Nationwide Randomized Clinical Trials. JAMA Cardiol. 2025 Jan 1;10(1):78-86. doi: 10.1001/jamacardio.2024.4648.

Reference Type DERIVED
PMID: 39550717 (View on PubMed)

Johansen ND, Vaduganathan M, Bhatt AS, Modin D, Chatur S, Claggett BL, Janstrup KH, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Krause TG, Biering-Sorensen T. Electronic nudges for sustained influenza vaccination uptake in older adults: the nationwide randomized NUDGE-FLU-2 trial. Nat Med. 2024 Nov;30(11):3142-3149. doi: 10.1038/s41591-024-03202-4. Epub 2024 Aug 30.

Reference Type DERIVED
PMID: 39215149 (View on PubMed)

Johansen ND, Vaduganathan M, Bhatt AS, Modin D, Chatur S, Claggett BL, Janstrup KH, Larsen CS, Larsen L, Wiese L, Dalager-Pedersen M, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Krause TG, Biering-Sorensen T. Rationale and design of NUDGE-FLU-CHRONIC and NUDGE-FLU-2: Two nationwide randomized trials of electronic nudges to increase influenza vaccination among patients with chronic diseases and older adults during the 2023/2024 influenza season. Am Heart J. 2024 Jun;272:23-36. doi: 10.1016/j.ahj.2024.03.003. Epub 2024 Mar 7.

Reference Type DERIVED
PMID: 38460754 (View on PubMed)

Other Identifiers

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NUDGE-FLU-2

Identifier Type: -

Identifier Source: org_study_id

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