NCT04097197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

September 18, 2019

Last Update Submit

May 29, 2020

Conditions

Keywords

Influenza VaccinesInfluenza, HumanPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • Flu vaccination refusal rate

    Percentage of patients refusing flu vaccination prior to intervention

    up to 6 months

Secondary Outcomes (3)

  • Prevalence of barriers to flu vaccination

    up to 6 months

  • Flu vaccination acceptance rate post-intervention

    up to 6 months

  • Flu vaccination rate

    up to 6 months

Study Arms (1)

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.

Behavioral: Brief educational intervention

Interventions

same as before

Patients receiving information

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dão Lafões Grouping of Primary Health Care Centres

Viseu, Dão Lafões, 3514-511, Portugal

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Before-after study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Department

Study Record Dates

First Submitted

September 18, 2019

First Posted

September 20, 2019

Study Start

October 14, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

June 1, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations