A Randomized Controlled Trial Evaluating an Online Intervention in Increasing Seasonal Influenza Vaccination Among Community Dwelling People Aged ≥65 Years

March 5, 2023 updated by: Zixin Wang, Chinese University of Hong Kong

A Randomized Controlled Trial Evaluating an Online Intervention Based on the Trans-Theoretical Model in Increasing Seasonal Influenza Vaccination Among Community Dwelling People Aged ≥65 Years

A non-blinded two-arm parallel randomized controlled trial will be conducted. Inclusion criteria are: 1) aged ≥65 years, 2) having Hong Kong ID, 3) Chinese speaking, 4) willing to be followed up by telephone, 5) having a smartphone, and 6) have not received SIV for the incoming flu season. Exclusion criteria include: 1) cognitive impairment, blindness or deafness, 2) not able to communicate with others effectively, and 3) with known contradictions of SIV (allergic to previous SIV, diagnosed/suspected egg allergy, with bleeding disorder or on warfarin). A total of 396 participants will be randomly assigned to either the intervention group (n=198) or the control group (n=198). Intervention group will watch an online health promotion video tailored to their current stage of change related to SIV uptake once every two weeks for four times (at week 0, 2, 4, and 6).

Participants in the control group will watch a same online video providing general advices related to SIV at week 0, 2, 4, and 6. All participants will be followed up by telephone 3 and 6 months after the baseline survey.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 666888
        • Centre for Health Behaviours Research, the Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥65 years,
  • Having Hong Kong ID
  • Chinese speaking
  • Willing to be followed up by telephone
  • Having a smartphone
  • Have not received seasonal influenza vaccination for the incoming flu season

Exclusion Criteria:

  • Cognitive impairment, blindness or deafness,
  • Not able to communicate with others effectively
  • With known contradictions of seasonal influenza vaccination listed by the Centre for Health Protection (allergic to previous SIV, diagnosed/suspected egg allergy, with bleeding disorder or on warfarin)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Participants will watch an online health promotion video tailored to their current stage of change related to SIV uptake once every two weeks for four times (at week 0, 2, 4, and 6)
Behavioral: online health promotion video
Participants will watch an online health promotion video tailored to their current stage of change related to seasonal influenza vaccination uptake once every two weeks for four times (at week 0, 2, 4, and 6)
Active Comparator: Control
Participants will watch a same online video providing general advices related to SIV at week 0, 2, 4, and 6
Behavioral: Control (same online health promotion video)
Participants will watch a same online video providing general advices related to seasonal influenza vaccination at week 0, 2, 4, and 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seasonal influenza vaccination uptake
Time Frame: 6 months
Self-reported uptake of one dose of seasonal influenza vaccination
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

July 30, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 5, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 17180411

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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