COVID-19NCT05087173
Effectiveness of Using Interactive Consulting System to Enhance Decision Aids of COVID-19 Vaccination
A study testing Chatbot in people with COVID-19, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the performance of an interactive chatbot and assess its effectiveness for enhancing informed decisions made by cataract patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Chatbot
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2021to 31 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals aged over 18 years who have been resident in the selected study district for more than six months;
- Willing to participate the study and provide informed consent.
Who cannot join
- Having ocular, hearing or mental disorders precluding reading or telephone interview.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yingfeng Zheng, MD, PhD
Guangzhou, Guangdong
Yingfeng Zheng, MD, PhD, +8613922286455, zhyfeng@mail.sysu.edu.cn
About this study
To evaluate the performance of an interactive chatbot and assess its effectiveness for enhancing informed decisions made by cataract patients.
- Conditions
- COVID-19
- Being tested
- Chatbot
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotDevice
An interactive chatbot for patient decision aid A chatbot of patient decision aid embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of COVID-19 vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Q&A chatbot | Experimental | A chatbot of patient decision aid embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of COVID-19 vaccination. Receives: Device: Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed choice about COVID-19 vaccination (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)
Informed choice is an aggregated measure of multiple measurements, including knowledge (a 10-item questionnaire that assesses knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses)
Measured: 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start11 Oct 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Zheng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087173
- Sponsor's protocol ID
- 2021KYPJ182
- Status last verified
- Jan 2023
- First submitted
- 20 Oct 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Interactive Consulting System to Enhance Decision Aids of COVID-19 Vaccination
- ClinicalTrials.gov ID
- NCT05087173
- Acronym / sponsor ID
- 2021KYPJ182
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Oct 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.
To evaluate the performance of an interactive chatbot and assess its effectiveness for enhancing informed decisions made by cataract patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interactive Q&A chatbot | Experimental | Device: ChatbotA chatbot of patient decision aid embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of COVID-19 vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals aged over 18 years who have been resident in the selected study district for more than six months;
- Willing to participate the study and provide informed consent.
Key exclusion criteria (1 listed)
- Having ocular, hearing or mental disorders precluding reading or telephone interview.
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 |
|---|---|---|
| ChatbotAn interactive chatbot for patient decision aid A chatbot of patient decision aid embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of COVID-19 vaccination. | Device | Interactive Q&A chatbot |
Primary outcome
Informed choice about COVID-19 vaccination (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)
Time frame: 2 weeks post intervention
Informed choice is an aggregated measure of multiple measurements, including knowledge (a 10-item questionnaire that assesses knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- 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 in people with COVID-19, run by Sun Yat-sen University at 1 site in China.
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 2 inclusion and 1 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 18 Jan 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed choice about COVID-19 vaccination (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score) (time frame: 2 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2023.