Vaccination RefusalNCT05155241
A Randomized Controlled Trial Evaluating an Online Intervention in Increasing Seasonal Influenza Vaccination Among Community Dwelling People Aged ≥65 Years
A study testing online health promotion video in people with Vaccination Refusal, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vaccination Refusal
- What is being tested?
- online health promotion video
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2021to 30 Jul 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Centre for Health Behaviours Research, the Chinese University of Hong Kong
Hong Kong, 666888
About this study
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
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.
- Conditions
- Vaccination Refusal
- Being tested
- online health promotion video, Control (same online health promotion video)
- Medical subject headings
- Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online health promotion videoBehavioural
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)Behavioural
Participants will watch a same online video providing general advices related to seasonal influenza vaccination at week 0, 2, 4, and 6
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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) Receives: Behavioral: online health promotion video |
| Control | Active comparator | Participants will watch a same online video providing general advices related to SIV at week 0, 2, 4, and 6 Receives: Behavioral: Control (same online health promotion video) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seasonal influenza vaccination uptake
Self-reported uptake of one dose of seasonal influenza vaccination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Dec 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaccination RefusalStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zixin Wang, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155241
- Sponsor's protocol ID
- 17180411
- Status last verified
- Mar 2023
- First submitted
- 1 Dec 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Z, Chan PS, Fang Y, Yu FY, Ye D, Zhang Q, Wong MCS, Mo PKH. Chatbot-Delivered Online Intervention to Promote Seasonal Influenza Vaccination During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332568. doi: 10.1001/jamanetworkopen.2023.32568.
PubMed 37695585
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05155241
- Acronym / sponsor ID
- 17180411
- Conditions
- Vaccination Refusal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 13 Dec 2021 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: online health promotion videoParticipants 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) |
| Control | Active comparator | Behavioral: Control (same online health promotion video)Participants will watch a same online video providing general advices related to SIV at week 0, 2, 4, and 6 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged ≥65 years,
- Having Hong Kong ID
- Chinese speaking
- Willing to be followed up by telephone
- Having a smartphone
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| online health promotion videoParticipants 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) | Behavioural | Intervention |
| 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 | Behavioural | Control |
Primary outcome
Seasonal influenza vaccination uptake
Time frame: 6 months
Self-reported uptake of one dose of seasonal influenza vaccination
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 7 Mar 2023.
- Derived from this study: PubMed 37695585Wang Z, Chan PS, Fang Y, Yu FY, Ye D, Zhang Q, Wong MCS, Mo PKH. Chatbot-Delivered Online Intervention to Promote Seasonal Influenza Vaccination During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332568. doi: 10.1001/jamanetworkopen.2023.32568.
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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 online health promotion video in people with Vaccination Refusal, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 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 7 Mar 2023. 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 Hong Kong. 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?
Seasonal influenza vaccination uptake (time frame: 6 months). 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 NCT05155241, which also lists 1 linked publication.
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 7 Mar 2023.