Flu, HumanFIVANCT04097197
Factors Influencing Flu Vaccination in Primary Health Care
A study testing Brief educational intervention in people with Flu, Human, run by Agrupamento de Centros de Saúde de Dão Lafões at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Flu, Human
- What is being tested?
- Brief educational intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 sitePortugal
- Study dates
- 14 Oct 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Dão Lafões Grouping of Primary Health Care Centres
Viseu, Dão Lafões, 3514-511
About this study
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.
Read the 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.
- Conditions
- Flu, Human
- Being tested
- Brief educational intervention
- Keywords
- Influenza Vaccines, Influenza, Human, Primary Health Care
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief educational interventionBehavioural
same as before
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving information | Experimental | 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. Receives: Behavioral: Brief educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flu vaccination refusal rate
Percentage of patients refusing flu vaccination prior to intervention
Measured: up to 6 months
Secondary outcomes (3)
Prevalence of barriers to flu vaccination
Percentage of participants mentioning a determined barrier to flu vaccination
Measured: up to 6 months
Flu vaccination acceptance rate post-intervention
Percentage of patients who accept receiving the flu vaccine after receiving the intervention
Measured: up to 6 months
Flu vaccination rate
Percentage of patients who have been vaccinated after the intervention
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start14 Oct 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flu, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before-after study
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agrupamento de Centros de Saúde de Dão Lafões
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Rosário, Agrupamento de Centros de Saúde de Dão Lafões
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097197
- Sponsor's protocol ID
- FIVA_2019
- Acronym
- FIVA
- Status last verified
- May 2020
- First submitted
- 18 Sep 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Flu Vaccination in Primary Health Care
- ClinicalTrials.gov ID
- NCT04097197
- Acronym / sponsor ID
- FIVA / FIVA_2019
- Conditions
- Flu, Human
- Keywords
- Influenza Vaccines, Influenza, Human, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Agrupamento de Centros de Saúde de Dão LafõesUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before-after study
| Arm | Type | Receives |
|---|---|---|
| Patients receiving information | Experimental | Behavioral: Brief educational interventionPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief educational interventionsame as before | Behavioural | Patients receiving information |
Primary outcome
Flu vaccination refusal rate
Time frame: up to 6 months
Percentage of patients refusing flu vaccination prior to intervention
3 secondary outcomes
Prevalence of barriers to flu vaccination
Time frame: up to 6 months
Flu vaccination acceptance rate post-intervention
Time frame: up to 6 months
Flu vaccination rate
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief educational intervention in people with Flu, Human, run by Agrupamento de Centros de Saúde de Dão Lafões at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flu vaccination refusal rate (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.