Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician

April 8, 2024 updated by: University Hospital, Montpellier
Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Adult patients over 45
  • Residing in the Occitanie region, France
  • With heart failure registered as ALD
  • Who have declared an attending physician
  • Who have not received a pneumococcal vaccination for more than 24 months (due to the length of time available in the database)

Exclusion criteria:

-None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Incentive letter for pneumococcal vaccination to the patient and to the GP
Other: Incentive letter for pneumococcal vaccination to the patient and to the GP
Incentive letter for pneumococcal vaccination to the patient and to the GP
No Intervention: No letter sent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1-year Pneumococcus vaccination rate
Time Frame: at 1-year
at 1-year

Secondary Outcome Measures

Outcome Measure
Time Frame
1-year all-cause hospital admission rate
Time Frame: at 1-year
at 1-year
1-year specific hospital admission rate
Time Frame: at 1-year
at 1-year
1-year all-cause mortality rate
Time Frame: at 1-year
at 1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202201265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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