Factors Influencing Flu Vaccination in Primary Health Care (FIVA)

May 29, 2020 updated by: Frederico Rosário, Agrupamento de Centros de Saúde de Dão Lafões
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

197

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

  • Portugal
    • Dão Lafões
      • Viseu, Dão Lafões, Portugal, 3514-511
        • Dão Lafões Grouping of Primary Health Care Centres

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients receiving information
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.
Behavioral: Brief educational intervention
same as before

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flu vaccination refusal rate
Time Frame: up to 6 months
Percentage of patients refusing flu vaccination prior to intervention
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of barriers to flu vaccination
Time Frame: up to 6 months
Percentage of participants mentioning a determined barrier to flu vaccination
up to 6 months
Flu vaccination acceptance rate post-intervention
Time Frame: up to 6 months
Percentage of patients who accept receiving the flu vaccine after receiving the intervention
up to 6 months
Flu vaccination rate
Time Frame: up to 6 months
Percentage of patients who have been vaccinated after the intervention
up to 6 months

Collaborators and Investigators

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

Sponsor

Agrupamento de Centros de Saúde de Dão Lafões

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)

October 14, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 29, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIVA_2019

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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