Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake Among Adults With Chronic Disease

Influenza Clinical Trial

Official title:

Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake Among Adults With Chronic Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06030739
• Other study ID #: NUDGE-FLU-CHRONIC
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 24, 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. This study will investigate whether digital behavioral nudges delivered via the official, mandatory Danish electronic letter system can increase influenza vaccine uptake among adults aged 18-64 years with chronic diseases.

Description:

The study is a prospective, randomized, open-label implementation trial. The study population will consist of persons aged 18-64 years identified as eligible for free-of-charge influenza vaccination due to a chronic condition. Subjects will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10). 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: 299881
• Est. completion date: May 31, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

1. Age 18-64 years

2. Must be registered in the Danish nationwide registries as meeting at least one of the following eligibility criteria for free-of-charge influenza vaccination in the Danish

public health system:

1. Chronic lung disease

2. Chronic cardiovascular disease other than hypertension

3. Type 1 or type 2 diabetes mellitus

4. Congenital or acquired immunodeficiency

5. Impaired breathing due to muscular weakness

6. Chronic renal or hepatic insufficiency

7. Other chronic conditions with an increased risk of severe influenza as determined by the treating physician

3. Access to the official, mandatory Danish electronic mailbox system Exclusion Criteria: None

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms
• Chronic Disease
• 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