NCT06486766

Brief Summary

The trial will investigate to what extent SMS reminders for influenza vaccination increases coverage of influenza vaccination among elderly from the majority population, and among elderly from immigrant groups with low vaccination coverage

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000,000

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Oct 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Oct 2025Jul 2026

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

August 7, 2024

Status Verified

June 1, 2024

Enrollment Period

3 months

First QC Date

June 27, 2024

Last Update Submit

August 6, 2024

Conditions

Keywords

influenza vaccinationadult vaccinationcoverageuptakebehavioral nudgingvaccine hesitancyundervaccinationmigrant health

Outcome Measures

Primary Outcomes (1)

  • Influenza vaccination coverage (%)

    The percent uptake of the influenza vaccine in the population of interest

    Three months following the intervention, during the 2025/2026 influenza season

Other Outcomes (1)

  • COVID-19 vaccination coverage (%)

    Three months following the intervention, during the 2025/2026 influenza season

Study Arms (3)

Control

NO INTERVENTION

Standard care: Influenza vaccination is generally recommended to all individuals aged 65 or older, but there is no systematic individual invitation/reminding/scheduling for vaccination by SMS or any other mode. The control arm is applicable to all three populations (general population, immigrants born in Poland, immigrants born in Ukraine)

Norwegian SMS

EXPERIMENTAL
Behavioral: Norwegian SMS

Polish/Ukrainian SMS

EXPERIMENTAL
Behavioral: Polish/Ukrainian SMS

Interventions

Norwegian SMSBEHAVIORAL

Individuals receive a SMS in Norwegian language at the start of the influenza season, to remind them they are recommended to get the influenza vaccine. This intervention arm is applicable to all three populations (general population, immigrants born in Poland, immigrants born in Ukraine)

Norwegian SMS

Individuals receive an SMS in the official language of their native country (i.e., Polish or Ukrainian) at the start of the influenza season, to remind them they are recommended to get the influenza vaccine. This intervention arm is only applicable to the two immigrant populations (immigrants born in Poland, immigrants born in Ukraine)

Polish/Ukrainian SMS

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 65+ (age at the end of 2025, i.e., born 1960 or earlier)
  • Resident in Norway and have a valid ID number on 1 September 2025
  • Have a registered mobile phone number

You may not qualify if:

  • Have received the 2025 influenza vaccine prior to the SMS nudge dispatch date
  • Have emigrated or died before SMS nudge dispatch date

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hansen BT, Klungsoyr O, Labberton AS, Saaksvuori L, Rydland KM, Odeskaug LE, Wisloff T, Meijerink H. Effectiveness of Text Messaging Nudging to Increase Coverage of Influenza Vaccination Among Older Adults in Norway (InfluSMS Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Feb 25;14:e63938. doi: 10.2196/63938.

MeSH Terms

Conditions

Influenza, HumanVaccination Hesitancy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Bo T Hansen, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome measure of the trial is based solely on routinely collected data and those reporting/registering this information will not be aware of whether a vaccinated individual has received an SMS nudge. Thus, the trial is blinded to the outcomes assessor. Moreover, treatment allocation is randomized and computer-generated, there is no interaction between the InfluSMS project team and study participants, and the InfluSMS researchers work with de-identified data and do not know the identity of any participant in the dataset. Due to the inherent characteristics of the intervention, treatment allocation cannot be blinded for participants.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The trial is conducted in three populations of elderly (aged 65 years or older) residing in Norway: (i) the general population; (ii) immigrants born in Poland; (iii) immigrants born in Ukraine. In all three populations, the control arm is standard care, i.e., no individual reminder for influenza vaccination. All populations have an intervention arm that will receive an SMS nudge in the Norwegian language. In addition, the Polish and Ukrainian immigrant populations include a second intervention arm that will receive an SMS nudge in Polish or Ukrainian, respectively.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

October 1, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

The project is not allowed to share the data. Data access requires legal permissions and applications for data must be directed to the registries involved