Influenza VaccinationNCT04568785
Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting
A study testing Brief Intervention for Influenza vaccine and Normal advice in people with Influenza Vaccination and Health Education, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Influenza virus has high morbidity rates during annual epidemics, with certain high-risk groups being particularly susceptible to complications and mortality. Vaccination is the main prevention measure, alongside with hygiene measures. Nevertheless, vaccine coverage remains low. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccination, Health Education
- What is being tested?
- Brief Intervention for Influenza vaccine and Normal advice
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to 31 Mar 2018
- 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
- Individuals in high-risk groups for influenza (paediatric and adult)
- Not intending to be vaccinated against the influenza virus during the current season.
- Informed consent to participate. In case of paediatric patients, parents signed the consent and made decisions about vaccination.
Who cannot join
- Language barrier
- Mental or physical conditions which make it difficult for the patient or their relatives to make decisions.
- Having previously participated in the pilot study.
Trial locations and contacts
1 site in 1 country.
About this study
Influenza virus has high morbidity rates during annual epidemics, with certain high-risk groups being particularly susceptible to complications and mortality. Vaccination is the main prevention measure, alongside with hygiene measures. Nevertheless, vaccine coverage remains low.
Some studies suggest that short, standardized interventions can improve coverage of several vaccines.
Read more
Hypothesis: Brief Intervention is an effective tool in improving vaccination coverage in people who have initially rejected it.
Objective: To determine the effectiveness of a Brief Intervention in increasing influenza vaccination (IIV) coverage compared with the usual advice in people who refuse it.
Method: cluster randomized clinical trial. The study population was individuals with high risk factors who initially refused the influenza vaccine. Professionals participants (doctors and nurses) were assigned randomly to the intervention group (brief intervention) and the control group (usual advice).
Read the detailed description
General objective: To determine the effectiveness of the use of BI for IIV compared to the usual advice, in people who refuse to be vaccinated.
Specific objectives:
- To examine the effectiveness of Brief Intervention compared to the usual advice in different risk groups (> 60 healthy, > 60 years old with a Risk Factor [RF], <60 years old with RF).
- Quantify influenza vaccine coverage in people with the most frequent RF.
- Record the patients' reasons for refusing to be vaccinated.
METHOD A cluster randomized controlled clinical trial. The reference population consisted of patients assigned to and treated by urban and rural health centres in the centre of Catalonia, an area with a population of approximately 405,000. 135,648 were the risk factor population that could be vaccinated against influenza virus.
The study population consisted of individuals with high risk factors who were treated in healthcare centres during the 2017 influenza campaign.
The study protocol was approved by the Research Ethics Committee (CEI) of the Institut Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol).
The participants (doctors and nurses) decided voluntarily whether or not to participate and they were randomly assigned to either the Intervention Group (IG) or the Control Group (CG).
The recruitment of patients suitable to participate in the study was carried out during the IIV campaign, as part of the health centre's routine activities. Patients with inclusion criteria who came to see a doctor or nurse were invited to participate in the study. Those who accepted participating signed an informed consent.
The intervention consisted of a standardized Brief Intervention for the Influenza Vaccination.
Data was collected anonymously and confidentially via the electronic health record of Catalonia [eCAP in Catalan]. The variables analysed for the two groups were: IIV at the end of the 2017 vaccination campaign (yes/no), age, IIV risk factors and reasons for non-vaccination.
- Conditions
- Influenza Vaccination, Health Education
- Being tested
- Brief Intervention for Influenza vaccine, Normal advice
- Keywords
- directive counseling, health education, influenza vaccines, primary health care, vaccination coverage
- Medical subject headings
- Influenza, Human, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention for Influenza vaccineBehavioural
Previous to the intervention, patients were asked about the reasons to reject the influenza vaccine. Brief Intervention was performed by the healthcare professional during the consultation. It was given verbally, with written support.
Normal adviceBehavioural
In the CG the influenza vaccine advice was the normal advice that professionals used to give their patients and was not asked for the reasons for the rejection of the vaccine to prevent them from influencing the advice.
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention group | Experimental | Intervention consisted of a standardized Brief Intervention, which varied depending on the reason the patient had given for refusing the vaccination. Receives: Behavioral: Brief Intervention for Influenza vaccine |
| Control group | Active comparator | the control group intervention was the normal advice that professionals used to give their patients Receives: Behavioral: Normal advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza vaccination status at the end of the Influenza vaccination campaign 2017.
% of reluctant patients vaccinated against Influenza at the end of the campaign 2017. Measurement tool: Influenza vaccine registered in patient's medical history
Measured: up to 3 months
Influenza vaccination status of the participants who received the Brief Intervention or the normal advice.
% of reluctant patients vaccinated against Influenza in the Intervention group or in the Control group. Measurement tool: Influenza vaccine registered in patient's medical history
Measured: up to 3 months
Secondary outcomes (1)
Reasons for rejecting Influenza Vaccination
% of the different reasons for rejecting Influenza Vaccination. Measurement tool: specific questionnaire.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start1 Oct 2017
- Primary completion31 Jan 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Influenza VaccinationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Muñoz Miralles, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568785
- Sponsor's protocol ID
- P17/224
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bish A, Yardley L, Nicoll A, Michie S. Factors associated with uptake of vaccination against pandemic influenza: a systematic review. Vaccine. 2011 Sep 2;29(38):6472-84. doi: 10.1016/j.vaccine.2011.06.107. Epub 2011 Jul 12.
PubMed 21756960Giese C, Mereckiene J, Danis K, O'Donnell J, O'Flanagan D, Cotter S. Low vaccination coverage for seasonal influenza and pneumococcal disease among adults at-risk and health care workers in Ireland, 2013: The key role of GPs in recommending vaccination. Vaccine. 2016 Jul 12;34(32):3657-62. doi: 10.1016/j.vaccine.2016.05.028. Epub 2016 Jun 7.
PubMed 27255466Picazo J, González Romo F, Salleras Sanmartí J, Bayas Rodríguez J, Álvarez Pasquín M. Encuesta sobre la vacunación de adultos en España. Gripe y neumococo. Vacunas. 2012; 13(3): 100-111. doi.10.1016/S1576-9887(12)70048-1
Stockwell MS, Kharbanda EO, Martinez RA, Vargas CY, Vawdrey DK, Camargo S. Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial. JAMA. 2012 Apr 25;307(16):1702-8. doi: 10.1001/jama.2012.502.
PubMed 22535855European Centre for Disease Prevention and Control. Catalogue of interventions addressing vaccine hesitancy. Stockholm: ECDC; 2017. doi: 10.2900/654210
Whitlock EP, Orleans CT, Pender N, Allan J. Evaluating primary care behavioral counseling interventions: an evidence-based approach. Am J Prev Med. 2002 May;22(4):267-84. doi: 10.1016/s0749-3797(02)00415-4.
PubMed 11988383Wong VW, Fong DY, Tarrant M. Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2014 Jan 14;14:19. doi: 10.1186/1471-2393-14-19.
PubMed 24423245Wong VWY, Fong DYT, Lok KYW, Wong JYH, Sing C, Choi AY, Yuen CYS, Tarrant M. Brief education to promote maternal influenza vaccine uptake: A randomized controlled trial. Vaccine. 2016 Oct 17;34(44):5243-5250. doi: 10.1016/j.vaccine.2016.09.019. Epub 2016 Sep 22.
PubMed 27667330Ferguson PE, Jordens CF, Gilroy NM. Patient and family education in HSCT: improving awareness of respiratory virus infection and influenza vaccination. A descriptive study and brief intervention. Bone Marrow Transplant. 2010 Apr;45(4):656-61. doi: 10.1038/bmt.2009.209. Epub 2009 Aug 17.
PubMed 19684629Chan SS, Leung DY, Leung AY, Lam C, Hung I, Chu D, Chan CK, Johnston J, Liu SH, Liang R, Lam TH, Yuen KY. A nurse-delivered brief health education intervention to improve pneumococcal vaccination rate among older patients with chronic diseases: a cluster randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):317-24. doi: 10.1016/j.ijnurstu.2014.06.008. Epub 2014 Jun 19.
PubMed 25012957Bonafide KE, Vanable PA. Male human papillomavirus vaccine acceptance is enhanced by a brief intervention that emphasizes both male-specific vaccine benefits and altruistic motives. Sex Transm Dis. 2015 Feb;42(2):76-80. doi: 10.1097/OLQ.0000000000000226.
PubMed 25585065Muñoz-Miralles R, Bonvehí Nadeu S, Sant Masoliver C, Martín Gallego A, Llamazares Robles MO, Mendioroz Peña J. Efectividad del consejo breve en la vacunación contra la gripe. Estudio piloto en atención primaria. Vacunas. 2019; 20(1): 18-24. doi.10.1016/j.vacun.2019.01.001
Nyhan B, Reifler J. Does correcting myths about the flu vaccine work? An experimental evaluation of the effects of corrective information. Vaccine. 2015 Jan 9;33(3):459-64. doi: 10.1016/j.vaccine.2014.11.017. Epub 2014 Dec 8.
PubMed 25499651Thomas RE, Lorenzetti DL. Interventions to increase influenza vaccination rates of those 60 years and older in the community. Cochrane Database Syst Rev. 2018 May 30;5(5):CD005188. doi: 10.1002/14651858.CD005188.pub4.
PubMed 29845606
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT04568785
- Acronym / sponsor ID
- P17/224
- Conditions
- Influenza Vaccination, Health Education
- Keywords
- directive counseling, health education, influenza vaccines, primary health care, vaccination coverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 29 Sep 2020 (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.
Influenza virus has high morbidity rates during annual epidemics, with certain high-risk groups being particularly susceptible to complications and mortality. Vaccination is the main prevention measure, alongside with hygiene measures. Nevertheless, vaccine coverage remains low.
Some studies suggest that short, standardized interventions can improve coverage of several vaccines.
Hypothesis: Brief Intervention is an effective tool in improving vaccination coverage in people who have initially rejected it.
Objective: To determine the effectiveness of a Brief Intervention in increasing influenza vaccination (IIV) coverage compared with the usual advice in people who refuse it.
Method: cluster randomized clinical trial. The study population was individuals with high risk factors who initially refused the influenza vaccine. Professionals participants (doctors and nurses) were assigned randomly to the intervention group (brief intervention) and the control group (usual advice).
Detailed description
General objective: To determine the effectiveness of the use of BI for IIV compared to the usual advice, in people who refuse to be vaccinated.
Specific objectives:
- To examine the effectiveness of Brief Intervention compared to the usual advice in different risk groups (> 60 healthy, > 60 years old with a Risk Factor [RF], <60 years old with RF).
- Quantify influenza vaccine coverage in people with the most frequent RF.
- Record the patients' reasons for refusing to be vaccinated.
METHOD A cluster randomized controlled clinical trial. The reference population consisted of patients assigned to and treated by urban and rural health centres in the centre of Catalonia, an area with a population of approximately 405,000. 135,648 were the risk factor population that could be vaccinated against influenza virus.
The study population consisted of individuals with high risk factors who were treated in healthcare centres during the 2017 influenza campaign.
The study protocol was approved by the Research Ethics Committee (CEI) of the Institut Universitari d'Investigació en Atenció Primària (IDIAP Jordi Gol).
The participants (doctors and nurses) decided voluntarily whether or not to participate and they were randomly assigned to either the Intervention Group (IG) or the Control Group (CG).
The recruitment of patients suitable to participate in the study was carried out during the IIV campaign, as part of the health centre's routine activities. Patients with inclusion criteria who came to see a doctor or nurse were invited to participate in the study. Those who accepted participating signed an informed consent.
The intervention consisted of a standardized Brief Intervention for the Influenza Vaccination.
Data was collected anonymously and confidentially via the electronic health record of Catalonia [eCAP in Catalan]. The variables analysed for the two groups were: IIV at the end of the 2017 vaccination campaign (yes/no), age, IIV risk factors and reasons for non-vaccination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention group | Experimental | Behavioral: Brief Intervention for Influenza vaccineIntervention consisted of a standardized Brief Intervention, which varied depending on the reason the patient had given for refusing the vaccination. |
| Control group | Active comparator | Behavioral: Normal advicethe control group intervention was the normal advice that professionals used to give their patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals in high-risk groups for influenza (paediatric and adult)
- Not intending to be vaccinated against the influenza virus during the current season.
- Informed consent to participate. In case of paediatric patients, parents signed the consent and made decisions about vaccination.
Key exclusion criteria (3 listed)
- Language barrier
- Mental or physical conditions which make it difficult for the patient or their relatives to make decisions.
- Having previously participated in the pilot study.
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 Intervention for Influenza vaccinePrevious to the intervention, patients were asked about the reasons to reject the influenza vaccine. Brief Intervention was performed by the healthcare professional during the consultation. It was given verbally, with written support. | Behavioural | Brief Intervention group |
| Normal adviceIn the CG the influenza vaccine advice was the normal advice that professionals used to give their patients and was not asked for the reasons for the rejection of the vaccine to prevent them from influencing the advice. | Behavioural | Control group |
Primary outcome
Influenza vaccination status at the end of the Influenza vaccination campaign 2017.
Time frame: up to 3 months
% of reluctant patients vaccinated against Influenza at the end of the campaign 2017. Measurement tool: Influenza vaccine registered in patient's medical history
Influenza vaccination status of the participants who received the Brief Intervention or the normal advice.
Time frame: up to 3 months
% of reluctant patients vaccinated against Influenza in the Intervention group or in the Control group. Measurement tool: Influenza vaccine registered in patient's medical history
1 secondary outcome
Reasons for rejecting Influenza Vaccination
Time frame: one day
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 29 Sep 2020.
- Background: PubMed 21756960Bish A, Yardley L, Nicoll A, Michie S. Factors associated with uptake of vaccination against pandemic influenza: a systematic review. Vaccine. 2011 Sep 2;29(38):6472-84. doi: 10.1016/j.vaccine.2011.06.107. Epub 2011 Jul 12.
- Background: PubMed 27255466Giese C, Mereckiene J, Danis K, O'Donnell J, O'Flanagan D, Cotter S. Low vaccination coverage for seasonal influenza and pneumococcal disease among adults at-risk and health care workers in Ireland, 2013: The key role of GPs in recommending vaccination. Vaccine. 2016 Jul 12;34(32):3657-62. doi: 10.1016/j.vaccine.2016.05.028. Epub 2016 Jun 7.
- BackgroundPicazo J, González Romo F, Salleras Sanmartí J, Bayas Rodríguez J, Álvarez Pasquín M. Encuesta sobre la vacunación de adultos en España. Gripe y neumococo. Vacunas. 2012; 13(3): 100-111. doi.10.1016/S1576-9887(12)70048-1
- Background: PubMed 22535855Stockwell MS, Kharbanda EO, Martinez RA, Vargas CY, Vawdrey DK, Camargo S. Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial. JAMA. 2012 Apr 25;307(16):1702-8. doi: 10.1001/jama.2012.502.
- BackgroundEuropean Centre for Disease Prevention and Control. Catalogue of interventions addressing vaccine hesitancy. Stockholm: ECDC; 2017. doi: 10.2900/654210
- Background: PubMed 11988383Whitlock EP, Orleans CT, Pender N, Allan J. Evaluating primary care behavioral counseling interventions: an evidence-based approach. Am J Prev Med. 2002 May;22(4):267-84. doi: 10.1016/s0749-3797(02)00415-4.
- Background: PubMed 24423245Wong VW, Fong DY, Tarrant M. Brief education to increase uptake of influenza vaccine among pregnant women: a study protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2014 Jan 14;14:19. doi: 10.1186/1471-2393-14-19.
- Background: PubMed 27667330Wong VWY, Fong DYT, Lok KYW, Wong JYH, Sing C, Choi AY, Yuen CYS, Tarrant M. Brief education to promote maternal influenza vaccine uptake: A randomized controlled trial. Vaccine. 2016 Oct 17;34(44):5243-5250. doi: 10.1016/j.vaccine.2016.09.019. Epub 2016 Sep 22.
- Background: PubMed 19684629Ferguson PE, Jordens CF, Gilroy NM. Patient and family education in HSCT: improving awareness of respiratory virus infection and influenza vaccination. A descriptive study and brief intervention. Bone Marrow Transplant. 2010 Apr;45(4):656-61. doi: 10.1038/bmt.2009.209. Epub 2009 Aug 17.
- Background: PubMed 25012957Chan SS, Leung DY, Leung AY, Lam C, Hung I, Chu D, Chan CK, Johnston J, Liu SH, Liang R, Lam TH, Yuen KY. A nurse-delivered brief health education intervention to improve pneumococcal vaccination rate among older patients with chronic diseases: a cluster randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):317-24. doi: 10.1016/j.ijnurstu.2014.06.008. Epub 2014 Jun 19.
- Background: PubMed 25585065Bonafide KE, Vanable PA. Male human papillomavirus vaccine acceptance is enhanced by a brief intervention that emphasizes both male-specific vaccine benefits and altruistic motives. Sex Transm Dis. 2015 Feb;42(2):76-80. doi: 10.1097/OLQ.0000000000000226.
- BackgroundMuñoz-Miralles R, Bonvehí Nadeu S, Sant Masoliver C, Martín Gallego A, Llamazares Robles MO, Mendioroz Peña J. Efectividad del consejo breve en la vacunación contra la gripe. Estudio piloto en atención primaria. Vacunas. 2019; 20(1): 18-24. doi.10.1016/j.vacun.2019.01.001
- 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 Intervention for Influenza vaccine and Normal advice in people with Influenza Vaccination and Health Education, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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 29 Sep 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 Spain. 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?
Influenza vaccination status at the end of the Influenza vaccination campaign 2017. (time frame: up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04568785, which also lists 14 linked publications.
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 29 Sep 2020.