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Factors Influencing Flu Vaccination in Primary Health Care (FIVA)

Primary Purpose

Flu, Human

Status

Completed

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Brief educational intervention

About this trial

This is an interventional prevention trial for Flu, Human focused on measuring Influenza Vaccines, Influenza, Human, Primary Health Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

People 65+ otherwise healthy;
Patients of any age diagnosed with at least one of the following conditions: Diabetes, Asthma, COPD, Coronary Disease or Hearth failure;
No history of flu vaccination in the previous year.

Exclusion Criteria:

Patients who have been vaccinated against the flu but who have no record of it in the clinical records;
Patients with contraindications to flu vaccination;
Patients that cannot be reached either by phone or letter.

Sites / Locations

Dão Lafões Grouping of Primary Health Care Centres

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients receiving information

Arm Description

Patients in the experimental arm will receive a brief educational intervention if they initially refuse flu vaccination. The intervention was designed towards the most common barriers to flu vaccination that were found after a brief review of the literature. After the intervention, patients will be asked again whether or not they wish to receive the flu vaccine.

Outcomes

Primary Outcome Measures

Flu vaccination refusal rate

Percentage of patients refusing flu vaccination prior to intervention

Secondary Outcome Measures

Prevalence of barriers to flu vaccination

Percentage of participants mentioning a determined barrier to flu vaccination

Flu vaccination acceptance rate post-intervention

Percentage of patients who accept receiving the flu vaccine after receiving the intervention

Flu vaccination rate

Percentage of patients who have been vaccinated after the intervention

Full Information

NCT ID

NCT04097197

First Posted

September 18, 2019

Last Updated

May 29, 2020

Sponsor

Agrupamento de Centros de Saúde de Dão Lafões

1. Study Identification

Unique Protocol Identification Number

NCT04097197

Brief Title

Factors Influencing Flu Vaccination in Primary Health Care

Acronym

FIVA

Official Title

Factors Influencing Flu Vaccination in Primary Health Care

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

October 14, 2019 (Actual)

Primary Completion Date

March 31, 2020 (Actual)

Study Completion Date

March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Agrupamento de Centros de Saúde de Dão Lafões

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to study the barriers to flu vaccination among at-risk people at the Primary Health Care level in order to increase the vaccination rates as recommended by the World Health Organization.

Detailed Description

People from vulnerable groups (e.g., those diagnosed with Diabetes, Chronic Obstructive Pulmonary Disease, Asthma) are at increased risk of developing complications from infection with influenza virus, that could ultimately result in death. Flu vaccination is recommended by many authorities, including the World Health Organization, as a means to decrease the risk of developing such life-threatening conditions. However, vaccination rates are well below the recommended threshold.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Flu, Human

Keywords

Influenza Vaccines, Influenza, Human, Primary Health Care

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Before-after study

Masking

None (Open Label)

Allocation

N/A

Enrollment

197 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients receiving information

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Brief educational intervention

Intervention Description

same as before

Primary Outcome Measure Information:

Title

Flu vaccination refusal rate

Description

Percentage of patients refusing flu vaccination prior to intervention

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Prevalence of barriers to flu vaccination

Description

Percentage of participants mentioning a determined barrier to flu vaccination

Time Frame

up to 6 months

Title

Flu vaccination acceptance rate post-intervention

Description

Percentage of patients who accept receiving the flu vaccine after receiving the intervention

Time Frame

up to 6 months

Title

Flu vaccination rate

Description

Percentage of patients who have been vaccinated after the intervention

Time Frame

up to 6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: People 65+ otherwise healthy; Patients of any age diagnosed with at least one of the following conditions: Diabetes, Asthma, COPD, Coronary Disease or Hearth failure; No history of flu vaccination in the previous year. Exclusion Criteria: Patients who have been vaccinated against the flu but who have no record of it in the clinical records; Patients with contraindications to flu vaccination; Patients that cannot be reached either by phone or letter.

Facility Information:

Facility Name

Dão Lafões Grouping of Primary Health Care Centres

City

Viseu

State/Province

Dão Lafões

ZIP/Postal Code

3514-511

Country

Portugal

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Factors Influencing Flu Vaccination in Primary Health Care

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