- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06486766
Effectiveness of SMS Nudging to Increase Coverage of Influenza Vaccination Among the Elderly (InfluSMS)
InfluSMS: Effectiveness of SMS Nudging to Increase Coverage of Influenza Vaccination Among Elderly From the Majority Population, and Among Elderly From Immigrant Groups With Low Vaccination Coverage
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: The coverage of influenza vaccination among elderly in Norway is insufficient, especially in some immigrant groups. To improve public health, there is a need for an intervention that can increase influenza vaccination coverage. Further, interventions tailored to reduce potential barriers among immigrants can reduce health inequities.
Objective: InfluSMS aims to determine if SMS nudging increases vaccination coverage among those aged 65 or older (i) in Norway's general population; (ii) among immigrants born in Poland; (iii) among immigrants born in Ukraine; and to evaluate the impact of SMS nudging in Norwegian versus in the official language of the native country of immigrants born in Poland or Ukraine.
Methods: InfluSMS is a pragmatic randomized controlled trial conducted among people aged 65 or older residing in Norway. Influenza vaccination coverage is the main outcome, measured in control and intervention arms for each of the three populations listed above. 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. Allocation to study arm is randomized, and the intervention will take place at the start of the 2025/2026 influenza season. All eligible individuals will be passively followed up through the National Immunisation Registry SYSVAK, from which individual influenza vaccination status three months after the SMS nudge will be extracted.
Results: Inclusion of participants will start in the third quarter of 2025, and the registry data will be available in the first quarter of 2026. Coverage rates of each strategy, and coverage differences between strategies will be presented.
Implications: SMS nudging could be integrated into the national influenza vaccination program if the trial shows it effectively increases influenza vaccination coverage among the elderly. Further, the trial will establish whether language is a barrier for influenza vaccination uptake among recent immigrant groups that have low influenza vaccination coverage, and to what extent this potential barrier can be diminished by SMS nudging in the official language of their native country.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hansen
- Phone Number: (+47) 21077000
- Email: folkehelseinstituttet@fhi.no
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Have received the 2025 influenza vaccine prior to the SMS nudge dispatch date
- Have emigrated or died before SMS nudge dispatch date
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
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)
|
|
|
Experimental: Norwegian SMS
|
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)
|
|
Experimental: Polish/Ukrainian 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Influenza vaccination coverage (%)
Time Frame: Three months following the intervention, during the 2025/2026 influenza season
|
The percent uptake of the influenza vaccine in the population of interest
|
Three months following the intervention, during the 2025/2026 influenza season
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
COVID-19 vaccination coverage (%)
Time Frame: Three months following the intervention, during the 2025/2026 influenza season
|
The percent uptake of the COVID-19 vaccine in the population of interest
|
Three months following the intervention, during the 2025/2026 influenza season
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bo T Hansen, PhD, Norwegian Institute of Public Health
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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