Vaccination RefusalNCT05772117
A RCT Evaluating an Online Intervention in Increasing Pneumococcal Vaccination Among Older Adults
A study testing Chatbot-delivered interventions tailored to stage of changes and Chatbot-delivered standard interventions in people with Vaccination Refusal, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To evaluate the relative efficacy of an online intervention based on the Trans-theoretical Model delivered by a fully-automated Chatbot with natural language processing functions versus a control in promoting pneumococcal vaccination uptake among Hong Kong people aged ≥65 years. 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?
- Chatbot-delivered interventions tailored to stage of changes and Chatbot-delivered standard interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Mar 2023to 31 Aug 2024
- 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
- have not received any penumococcal vaccination
- willing to be followed up by telephone
- having a smartphone
- able to send and read text/voice messages via smartphone.
Who cannot join
- blindness or deafness
- not able to communicate with others effectively
- with known contradictions of pneumococcal vaccination
- having been diagnosed with major psychiatric illness
- scored ≤16 in the validated telephone version of the Cantonese Mini-mental State Examination (T-CMMSE).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Centre for Health Behaviours Research, the Chinese University of Hong Kong
Hong Kong, 666888
Zixin Wang, PhD, +852 22528740, wangzx@cuhk.edu.hk
About this study
Official title: A Randomized Controlled Trial Evaluating a Theory-based Online Intervention Via Fully Automated Chatbot in Increasing Pneumococcal Vaccination Among Community Dwelling Individuals Aged ≥65 Years
To evaluate the relative efficacy of an online intervention based on the Trans-theoretical Model delivered by a fully-automated Chatbot with natural language processing functions versus a control in promoting pneumococcal vaccination uptake among Hong Kong people aged ≥65 years. A total of 374 participants will be randomized evenly to either the intervention group or the control group. Participants in the intervention group will receive Chatbot-delivered interventions tailored to their stage of change regarding PV uptake in a conversational way at Month 0, 1, 2, and 3. Participants in the control group will receive Chatbot-delivered general information related to PV at Month 0, 1, 2, and 3. All participants will be followed up 6 and 12 months after completion of the intervention.
- Conditions
- Vaccination Refusal
- Being tested
- Chatbot-delivered interventions tailored to stage of changes, Chatbot-delivered standard interventions
- Medical subject headings
- Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot-delivered interventions tailored to stage of changesBehavioural
Participants receive Chatbot-delivered interventions tailored to their stage of change regarding PV uptake in a conversational way at Month 0, 1, 2, and 3.
Chatbot-delivered standard interventionsBehavioural
Participants receive Chatbot-delivered general information related to PV at Month 0, 1, 2, and 3.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive Chatbot-delivered interventions tailored to their stage of change regarding PV uptake in a conversational way at Month 0, 1, 2, and 3. Receives: Behavioral: Chatbot-delivered interventions tailored to stage of changes |
| Control | Active comparator | Participants receive Chatbot-delivered general information related to PV at Month 0, 1, 2, and 3. Receives: Behavioral: Chatbot-delivered standard interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumococcal vaccination uptake
Self-reported uptake of pneumococcal vaccination within the 12-month follow-up period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start13 Mar 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
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
- 374 participants (estimated)
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
- NCT05772117
- Sponsor's protocol ID
- 20190972
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Z, Chen S, Poon J, Han SC, Ye D, Yu FY, Fang Y, Ni Z, Wong MCS, Mo PKH. A Hybrid Chatbot to Promote Pneumococcal Vaccination Among Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2535813. doi: 10.1001/jamanetworkopen.2025.35813.
PubMed 41060654
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating a Theory-based Online Intervention Via Fully Automated Chatbot in Increasing Pneumococcal Vaccination Among Community Dwelling Individuals Aged ≥65 Years
- ClinicalTrials.gov ID
- NCT05772117
- Acronym / sponsor ID
- 20190972
- Conditions
- Vaccination Refusal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 16 Mar 2023 (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.
To evaluate the relative efficacy of an online intervention based on the Trans-theoretical Model delivered by a fully-automated Chatbot with natural language processing functions versus a control in promoting pneumococcal vaccination uptake among Hong Kong people aged ≥65 years. A total of 374 participants will be randomized evenly to either the intervention group or the control group. Participants in the intervention group will receive Chatbot-delivered interventions tailored to their stage of change regarding PV uptake in a conversational way at Month 0, 1, 2, and 3. Participants in the control group will receive Chatbot-delivered general information related to PV at Month 0, 1, 2, and 3. All participants will be followed up 6 and 12 months after completion of the intervention.
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: Chatbot-delivered interventions tailored to stage of changesParticipants receive Chatbot-delivered interventions tailored to their stage of change regarding PV uptake in a conversational way at Month 0, 1, 2, and 3. |
| Control | Active comparator | Behavioral: Chatbot-delivered standard interventionsParticipants receive Chatbot-delivered general information related to PV at Month 0, 1, 2, and 3. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- aged ≥65 years
- having Hong Kong ID
- Chinese speaking
- have not received any penumococcal vaccination
- willing to be followed up by telephone
Key exclusion criteria (5 listed)
- blindness or deafness
- not able to communicate with others effectively
- with known contradictions of pneumococcal vaccination
- having been diagnosed with major psychiatric illness
- scored ≤16 in the validated telephone version of the Cantonese Mini-mental State Examination (T-CMMSE).
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 |
|---|---|---|
| Chatbot-delivered interventions tailored to stage of changesParticipants receive Chatbot-delivered interventions tailored to their stage of change regarding PV uptake in a conversational way at Month 0, 1, 2, and 3. | Behavioural | Intervention |
| Chatbot-delivered standard interventionsParticipants receive Chatbot-delivered general information related to PV at Month 0, 1, 2, and 3. | Behavioural | Control |
Primary outcome
Pneumococcal vaccination uptake
Time frame: 12 months
Self-reported uptake of pneumococcal vaccination within the 12-month follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 41060654Wang Z, Chen S, Poon J, Han SC, Ye D, Yu FY, Fang Y, Ni Z, Wong MCS, Mo PKH. A Hybrid Chatbot to Promote Pneumococcal Vaccination Among Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2535813. doi: 10.1001/jamanetworkopen.2025.35813.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot-delivered interventions tailored to stage of changes and Chatbot-delivered standard interventions 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zixin Wang, PhD (+852 22528740, wangzx@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumococcal vaccination uptake (time frame: 12 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 NCT05772117, 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 6 Apr 2023.