Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT05542004
Status:
COMPLETED
Last Update Posted:
2024-10-10
First Post:
2021-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 964870}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2022-09-13', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with laboratory-confirmed influenza', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of participants with a hospitalization with influenza or pneumonia', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of participants with any hospitalization', 'timeFrame': 'Up to 8 months'}, {'measure': 'All-cause mortality', 'timeFrame': 'Up to 8 months'}, {'measure': 'Composite of incident heart failure, heart failure hospitalization, or cardiovascular death', 'timeFrame': 'Up to 8 months'}, {'measure': 'Composite of myocardial infarction, stroke, or cardiovascular death', 'timeFrame': 'Up to 8 months'}, {'measure': 'Composite of myocardial infarction, coronary revascularization, stroke, or cardiovascular death', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of participants with incident heart failure or heart failure hospitalization', 'timeFrame': 'Up to 8 months'}, {'measure': 'Cardiovascular death', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of participants with myocardial infarction', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of participants with coronary revascularization', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of participants with stroke', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of contacts to general practitioner (excluding vaccination visit)', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of participants with laboratory-confirmed COVID-19', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of participants with a hospitalization due to COVID-19', 'timeFrame': 'Up to 8 months'}, {'measure': 'Number of participants who received a COVID-19 vaccine', 'timeFrame': 'Up to 3 months'}], 'primaryOutcomes': [{'measure': 'Number of participants who received an influenza vaccine', 'timeFrame': 'Up to 3 months'}], 'secondaryOutcomes': [{'measure': 'Time from intervention delivery to influenza vaccination', 'timeFrame': 'Up to 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza', 'Vaccination', 'Nudging', 'Behavioral Science'], 'conditions': ['Influenza', 'Behavior and Behavior Mechanisms']}, 'referencesModule': {'references': [{'pmid': '39550717', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38498876', 'type': 'DERIVED', 'citation': 'Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson S, Loiacono MM, Harris RC, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Krause TG, Biering-Sorensen T. Clinical Outcomes With Electronic Nudges to Increase Influenza Vaccination : A Prespecified Analysis of a Nationwide, Pragmatic, Registry-Based, Randomized Implementation Trial. Ann Intern Med. 2024 Apr;177(4):476-483. doi: 10.7326/M23-2638. Epub 2024 Mar 19.'}, {'pmid': '38117499', 'type': 'DERIVED', 'citation': 'Lassen MCH, Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson SI, Loiacono MM, Fralick M, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Krause TG, Biering-Sorensen T. Electronically Delivered Nudges to Increase Influenza Vaccination Uptake in Older Adults With Diabetes: A Secondary Analysis of the NUDGE-FLU Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2347630. doi: 10.1001/jamanetworkopen.2023.47630.'}, {'pmid': '37211967', 'type': 'DERIVED', 'citation': 'Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson S, Loiacono MM, Harris RC, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Electronic nudges to increase influenza vaccination uptake among patients with heart failure: A pre-specified analysis of the NUDGE-FLU trial. Eur J Heart Fail. 2023 Aug;25(8):1450-1458. doi: 10.1002/ejhf.2913. Epub 2023 Jun 4.'}, {'pmid': '36889332', 'type': 'DERIVED', 'citation': 'Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson SI, Loiacono MM, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial. Lancet. 2023 Apr 1;401(10382):1103-1114. doi: 10.1016/S0140-6736(23)00349-5. Epub 2023 Mar 5.'}, {'pmid': '36871213', 'type': 'DERIVED', 'citation': 'Modin D, Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Claggett BL, Dueger EL, Samson SI, Loiacono MM, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Jean-Marie Martel C, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Effect of Electronic Nudges on Influenza Vaccination Rate in Older Adults With Cardiovascular Disease: Prespecified Analysis of the NUDGE-FLU Trial. Circulation. 2023 May 2;147(18):1345-1354. doi: 10.1161/CIRCULATIONAHA.123.064270. Epub 2023 Mar 5.'}, {'pmid': '36801265', 'type': 'DERIVED', 'citation': 'Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson S, Loiacono MM, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake (NUDGE-FLU): Study protocol for a nationwide randomized implementation trial. Am Heart J. 2023 Jun;260:58-71. doi: 10.1016/j.ahj.2023.02.009. Epub 2023 Feb 17.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>=65 years at January 15, 2023 (eligible for free influenza vaccination in the official Danish vaccination program)\n2. Access to the official, mandatory Danish electronic mailbox system\n\nExclusion Criteria:\n\n1\\) Persons living in nursing homes'}, 'identificationModule': {'nctId': 'NCT05542004', 'acronym': 'NUDGE-FLU', 'briefTitle': 'Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake', 'organization': {'class': 'OTHER', 'fullName': 'Herlev and Gentofte Hospital'}, 'officialTitle': 'Nationwide Utilization of Danish Government Electronic Letter System for Increasing InFLUenza Vaccine Uptake', 'orgStudyIdInfo': {'id': 'FLU00180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No letter'}, {'type': 'EXPERIMENTAL', 'label': 'Standard Letter', 'description': 'This group will receive a standard letter on the benefits of influenza vaccination without behavioral economic enhancement', 'interventionNames': ['Behavioral: Behavioral Economic Principles']}, {'type': 'EXPERIMENTAL', 'label': 'Priming & Hot State Activation - 1 reminder', 'description': 'The standard letter sent out two times instead of once', 'interventionNames': ['Behavioral: Behavioral Economic Principles']}, {'type': 'EXPERIMENTAL', 'label': 'Depersonalized Letter', 'description': "The standard letter without the recipient's name", 'interventionNames': ['Behavioral: Behavioral Economic Principles']}, {'type': 'EXPERIMENTAL', 'label': 'Gain-Framing/Context', 'description': 'Text added to the standard letter employing the specified behavioral economic principle', 'interventionNames': ['Behavioral: Behavioral Economic Principles']}, {'type': 'EXPERIMENTAL', 'label': 'Loss-Framing/Context', 'description': 'Text added to the standard letter employing the specified behavioral economic principle', 'interventionNames': ['Behavioral: Behavioral Economic Principles']}, {'type': 'EXPERIMENTAL', 'label': 'Collective Goal', 'description': 'Text added to the standard letter employing the specified behavioral economic principle', 'interventionNames': ['Behavioral: Behavioral Economic Principles']}, {'type': 'EXPERIMENTAL', 'label': 'Active Choice/Implementation Intention Prompt', 'description': 'Text added to the standard letter employing the specified behavioral economic principle', 'interventionNames': ['Behavioral: Behavioral Economic Principles']}, {'type': 'EXPERIMENTAL', 'label': 'Cardiovascular Gain Frame', 'description': 'Text added to the standard letter employing the specified behavioral economic principle', 'interventionNames': ['Behavioral: Behavioral Economic Principles']}, {'type': 'EXPERIMENTAL', 'label': 'Expert Authority', 'description': 'Text added to the standard letter employing the specified behavioral economic principle', 'interventionNames': ['Behavioral: Behavioral Economic Principles']}], 'interventions': [{'name': 'Behavioral Economic Principles', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Active Choice/Implementation Intention Prompt', 'Cardiovascular Gain Frame', 'Collective Goal', 'Depersonalized Letter', 'Expert Authority', 'Gain-Framing/Context', 'Loss-Framing/Context', 'Priming & Hot State Activation - 1 reminder', 'Standard Letter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'state': 'Capital Region', 'country': 'Denmark', 'facility': 'Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Tor Biering-Sørensen, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tor Biering-Sørensen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Statens Serum Institut', 'class': 'OTHER'}, {'name': 'Sanofi Pasteur, a Sanofi Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD, MPH', 'investigatorFullName': 'Tor Biering-Sørensen', 'investigatorAffiliation': 'Herlev and Gentofte Hospital'}}}}