FIVA: Factors Influencing Flu Vaccination in Primary Health Care

Sponsor

Agrupamento de Centros de Saúde de Dão Lafões (Other)

Overall Status

Completed

CT.gov ID

NCT04097197

Collaborator

(none)

197

Enrollment

Location

Arm

5.6

Actual Duration (Months)

35.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Flu, Human	Behavioral: Brief educational intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

197 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Before-after studyBefore-after study

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Factors Influencing Flu Vaccination in Primary Health Care

Actual Study Start Date :

Oct 14, 2019

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Flu vaccination refusal rate [up to 6 months]
Percentage of patients refusing flu vaccination prior to intervention

Secondary Outcome Measures

Prevalence of barriers to flu vaccination [up to 6 months]
Percentage of participants mentioning a determined barrier to flu vaccination
Flu vaccination acceptance rate post-intervention [up to 6 months]
Percentage of patients who accept receiving the flu vaccine after receiving the intervention
Flu vaccination rate [up to 6 months]
Percentage of patients who have been vaccinated after the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dão Lafões Grouping of Primary Health Care Centres	Viseu	Dão Lafões	Portugal	3514-511

Sponsors and Collaborators

Agrupamento de Centros de Saúde de Dão Lafões

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Frederico Rosário, Head of Research Department, Agrupamento de Centros de Saúde de Dão Lafões

ClinicalTrials.gov Identifier:

NCT04097197

Other Study ID Numbers:

FIVA_2019

First Posted:

Sep 20, 2019

Last Update Posted:

Jun 1, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Frederico Rosário, Head of Research Department, Agrupamento de Centros de Saúde de Dão Lafões

Influenza Vaccines

Influenza, Human

Primary Health Care

Additional relevant MeSH terms:

Influenza, Human

Study Results

No Results Posted as of Jun 1, 2020