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NCT05155241 Clinical Trial

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

Vaccination Refusal Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05155241
Other study ID # 17180411
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date July 30, 2022

Study information
Verified date March 2023
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 396
Est. completion date July 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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)
• 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

Locations
Country Name City State
Hong Kong Centre for Health Behaviours Research, the Chinese University of Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome
Type Measure Description Time frame Safety issue
Primary Seasonal influenza vaccination uptake Self-reported uptake of one dose of seasonal influenza vaccination 6 months
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