NCT06360315

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

April 8, 2024

Last Update Submit

April 8, 2024

Conditions

Keywords

Heart failureHospitalizationPneumococcal vaccination

Outcome Measures

Primary Outcomes (1)

  • 1-year Pneumococcus vaccination rate

    at 1-year

Secondary Outcomes (3)

  • 1-year all-cause hospital admission rate

    at 1-year

  • 1-year specific hospital admission rate

    at 1-year

  • 1-year all-cause mortality rate

    at 1-year

Study Arms (2)

Incentive letter for pneumococcal vaccination to the patient and to the GP

EXPERIMENTAL
Other: Incentive letter for pneumococcal vaccination to the patient and to the GP

No letter sent

NO INTERVENTION

Interventions

Incentive letter for pneumococcal vaccination to the patient and to the GP

Incentive letter for pneumococcal vaccination to the patient and to the GP

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

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

April 8, 2024

First Posted

April 11, 2024

Study Start

January 2, 2023

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations