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Active, not recruitingNCT06360315Updated Apr 11, 2024

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

An interventional study of Incentive letter for pneumococcal vaccination to the patient and to the GP in Chronic Heart Failure, sponsored by University Hospital, Montpellier. Active, not recruiting at 1 site in France. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as active, not recruiting.
  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2023, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
12,000
Allocation
Randomized
Ages
45 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Chronic Heart Failure

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Keywords

  • Heart failure
  • Hospitalization
  • Pneumococcal vaccination
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's planned enrollment of 12,000 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria:

-None

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12,000 participants (estimated)

Study arms

  • 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

  • No intervention
    No letter sent

Interventions

  • OtherIncentive letter for pneumococcal vaccination to the patient and to the GP

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

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What researchers measure

Primary outcomes

  1. 1-year Pneumococcus vaccination rate

    Time frame: at 1-year

Secondary outcomes

  1. 1-year all-cause hospital admission rate

    Time frame: at 1-year

  2. 1-year specific hospital admission rate

    Time frame: at 1-year

  3. 1-year all-cause mortality rate

    Time frame: at 1-year

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Study locations

1 site
  • Montpellier University Hospital
    Montpellier, 34090, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06360315
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Apr 11, 2024
Start date
Jan 2, 2023
Primary completion
Apr 2024 (estimated)
Completion
Jun 2024 (estimated)
Last update
Apr 11, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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