NCT06123936

Brief Summary

This study is a clinical trial designed to assess the impact on influenza vaccination rates among people aged over 65 of a telephone text message recalling them to be vaccinated by their GP. Twenty-two GPs will be randomly selected in each arm (recall versus usual care, 1:1). Each GP will include a maximum of 210 patients by random selection from their patient list. A difference of 4 percentage points is expected between the two arms at the end vaccination campaign in the vaccination rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
8,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 16, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

October 16, 2023

Last Update Submit

November 13, 2023

Conditions

Keywords

ReminderVaccination campaignInfluenza

Outcome Measures

Primary Outcomes (1)

  • The influenza vaccination rate will be calculated as the ratio between the number of patients vaccinated (those who will report having been vaccinated in the questionnaire send at the end of the campaign) and the number of patients aged 65 years and over

    The influenza vaccination rate will be calculated as the ratio between the number of patients vaccinated (i.e., those who will report having been vaccinated during the vaccination campaign in the questionnaire send at the end of the campaign) and the number of patients aged 65 years and over.

    12 months

Secondary Outcomes (4)

  • 1/ Social inequalities related to the intervention, based on individual and ecological indicators (social deprivation index for example) will be estimated via absolute indicators (SII: slope of the inequality index) and relative (RII: relative inequality

    1 year

  • 2/ Acceptability of reminders (in the intervention arm only) based on the description of the patients answers to the related question in the questionnaires. This outcome is assessed by questionnaire.

    1 year

  • 3/ Reasons for non-vaccination will be described (stratified by trial arm) based on the description of the patients answers to the related question in the questionnaires.This outcome is assessed by questionnaire.

    1 year

  • 4/ Characteristics of participating GPs based on the description of the physicians answers to the related question in the questionnaires. These outcomes are assessed by the physician questionnaire.

    1 year

Study Arms (2)

Experimental group

EXPERIMENTAL

GPs selected at random in the intervention arm "Recall" will recall their patients to be vaccinated via the recall module integrated into their Eo medical software

Other: Reminder

No intervention group

NO INTERVENTION

GPs in the ""usual care"" or ""control"" arm will not recall their patients to be vaccinated. GPs with their medical software. They will worked as usual.

Interventions

At mid-campaign, GPs in the interventional arm will recall their patients to be vaccinated via the reminder module Eo software * This recall will be carried out as follows: patients whose medical records include a number likely to receive telephone text messages will be recalled by this means Two generic messages that doctors can choose will be proposed by the call-back module integrated into the Eo medical software * In addition, the recall module will offer to send a postal letter with the same content as the text message to patients who do not have a mobile phone number in the business software but do have a postal address * The recall module will also provide the doctor with a list of patients who have neither a mobile phone number or a postal address, so that he can recall them to be vaccinated orally by landline telephone or in consultation when they next visit. The type of recall and the date of it will be notified in the medical file of each patient.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • To be a GPs
  • To be based in Ile-de-France (Paris region, France)
  • To be a user of the Eo medical software
  • belonging to the list of attending physicians of the participating GPs
  • being 65 years of age or older
  • having a medical file in the GP's Eo medical software
  • having been selected at random if the number of patients aged 65 or over exceeds 210 patients (for 44 participating GPs).

You may not qualify if:

  • Patients for which their attending physicians considers participating inappropriate (e.g. palliative care)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cabinet medical Lahire (01)

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Laurent RIGAL, Professor

    Université de Paris-Saclay

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

November 9, 2023

Study Start

October 30, 2023

Primary Completion

October 30, 2024

Study Completion

February 28, 2025

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations