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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04097197
Other study ID # FIVA_2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2019
Est. completion date March 31, 2020

Study information

Verified date May 2020
Source Agrupamento de Centros de Saúde de Dão Lafões
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brief educational intervention
same as before

Locations

Country Name City State
Portugal Dão Lafões Grouping of Primary Health Care Centres Viseu Dão Lafões

Sponsors (1)

Lead Sponsor Collaborator
Agrupamento de Centros de Saúde de Dão Lafões

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Flu vaccination refusal rate Percentage of patients refusing flu vaccination prior to intervention up to 6 months
Secondary Prevalence of barriers to flu vaccination Percentage of participants mentioning a determined barrier to flu vaccination up to 6 months
Secondary Flu vaccination acceptance rate post-intervention Percentage of patients who accept receiving the flu vaccine after receiving the intervention up to 6 months
Secondary Flu vaccination rate Percentage of patients who have been vaccinated after the intervention up to 6 months
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