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Nationwide Utilization of Danish Government Electronic Letter System for Confirming the Effectiveness of Behavioral Nudges in Increasing InFLUenza Vaccine Uptake Among Older Adults (NUDGE-FLU-2)

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ClinicalTrials.gov Identifier: NCT06030726
Recruitment Status : Recruiting
First Posted : September 11, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Tor Biering-Sørensen, Herlev and Gentofte Hospital

Study Description
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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. 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.

Condition or disease Intervention/treatment Phase
Influenza Behavior and Behavior Mechanisms Behavioral: Behavioral Economic Principles Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : September 15, 2023
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual Care
No letter
Experimental: Standard Letter
This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement
 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.
Experimental: Repeated Letter
The standard letter sent out two times instead of once
 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.
Experimental: Cardiovascular Gain-Framing Letter
Text added to the standard letter highlighting potential cardiovascular benefits of influenza vaccination
 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.
Experimental: Respiratory Gain-Framing Letter
Text added to the standard letter highlighting potential respiratory disease-related benefits of influenza vaccination
 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.
Experimental: Implementation Intention Prompt Letter
Implementation intention prompt added to the standard letter
 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.
Experimental: Loss-Framing Letter
Text added to the standard letter highlighting potential risks of not receiving influenza vaccination
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who received an influenza vaccine [ Time Frame: Up to 3 months ]

Secondary Outcome Measures :
  1. Time from intervention delivery to influenza vaccination [ Time Frame: Up to 3 months ]

Other Outcome Measures:
  1. Number of participants with laboratory-confirmed influenza [ Time Frame: Up to 8 months ]
  2. Number of participants with a hospitalization for influenza or pneumonia [ Time Frame: Up to 8 months ]
  3. Number of participants with a hospitalization for any respiratory disease [ Time Frame: Up to 8 months ]
  4. Number of participants with a hospitalization for any cardio-respiratory disease [ Time Frame: Up to 8 months ]
  5. Number of participants with a hospitalization for any cardiovascular disease [ Time Frame: Up to 8 months ]
  6. Number of participants with any hospitalization [ Time Frame: Up to 8 months ]
  7. Total number of hospitalizations (first and recurrent) [ Time Frame: Up to 8 months ]
  8. All-cause mortality [ Time Frame: Up to 8 months ]
  9. Composite of incident heart failure, heart failure hospitalization, or cardiovascular death [ Time Frame: Up to 8 months ]
  10. Composite of myocardial infarction, stroke, or cardiovascular death [ Time Frame: Up to 8 months ]
  11. Composite of myocardial infarction, coronary revascularization, stroke, or cardiovascular death [ Time Frame: Up to 8 months ]
  12. Number of participants with incident heart failure or heart failure hospitalization [ Time Frame: Up to 8 months ]
  13. Total number of heart failure events (incident heart failure and first and recurrent heart failure hospitalizations) [ Time Frame: Up to 8 months ]
  14. Cardiovascular death [ Time Frame: Up to 8 months ]
  15. Number of participants with myocardial infarction [ Time Frame: Up to 8 months ]
  16. Number of participants with coronary revascularization [ Time Frame: Up to 8 months ]
  17. Number of participants with stroke [ Time Frame: Up to 8 months ]
  18. Number of participants with incident atrial fibrillation or atrial fibrillation hospitalization [ Time Frame: Up to 8 months ]
  19. Number of contacts to general practitioner (excluding vaccination visit) [ Time Frame: Up to 8 months ]
  20. Number of participants with laboratory-confirmed COVID-19 [ Time Frame: Up to 8 months ]
  21. Number of participants with a hospitalization for COVID-19 [ Time Frame: Up to 8 months ]
  22. Number of participants who received a COVID-19 vaccine [ Time Frame: Up to 3 months ]
  23. Number of participants who filled a prescription for any guideline-directed medical therapy for heart failure [ Time Frame: Up to 8 months ]
  24. Total number of filled prescriptions for guideline-directed medical therapy for heart failure [ Time Frame: Up to 8 months ]
  25. Number of participants who filled a prescription for a sodium-glucose cotransporter 2 inhibitor or glucagon-like peptide 1 receptor agonist [ Time Frame: Up to 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06030726


Contacts
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Contact: Niklas Dyrby Johansen, MD +4520204794 niklas.dyrby.johansen@regionh.dk

Locations
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Denmark
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte Recruiting
Hellerup, Hovedstaden, Denmark, 2900
Contact: Niklas Dyrby Johansen, MD    +4520204794    niklas.dyrby.johansen@regionh.dk   
Contact: Tor Biering-Sørensen, MD, MSc, MPH, PhD    +4528933590    tor.biering-soerensen@regionh.dk   
Principal Investigator: Tor Biering-Sørensen, MD, MSc, MPH, PhD         
Sponsors and Collaborators
Tor Biering-Sørensen
Investigators
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Principal Investigator: Tor Biering-Sørensen, MD, MSc, MPH, PhD Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
More Information
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Responsible Party: Tor Biering-Sørensen, Professor, MD, MSc, MPH, PhD, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT06030726    
Other Study ID Numbers: NUDGE-FLU-2
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tor Biering-Sørensen, Herlev and Gentofte Hospital:
Influenza
Vaccination
Nudging
Behavioral Science
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases