Healthcare WorkersNCT04881227
The Impact of a Chatbot on COVID-19 Vaccine Perceptions and Intentions in ESPERES Cohort (ESPERES-COVID-19-CHATBOT)
A study testing Chatbot on COVID-19 vaccine hesitancy in people with Healthcare Workers and Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Vaccine hesitancy also concerns healthcare workers (HCWs). However, HCWs are at the frontline of the COVID-19 pandemic and identified as a priority target group for COVID-19 vaccines. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthcare Workers, Covid19
- What is being tested?
- Chatbot on COVID-19 vaccine hesitancy
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2021to 15 Oct 2021
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Legal age
- Healthcare workers defined as individuals who currently work in a setting where individuals receive healthcare (i.e. individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as administrative office, housekeeping, food service, etc.)
- Included in ESPERES cohort and with the initial questionnaire completed
- Agreeing to participate (digital consent)
Who cannot join
- No internet access
- Vaccinated against COVID-19 (at least one dose)
Trial locations and contacts
1 site in 1 country.
France1 site
Pitié-Salpêtrière - Charles Foix, AP-HP
Paris, Île-de-France Region, 75013
About this study
Official title: The ESPERES Prospective Cohort of Healthcare Workers in France: Study on the Impact of a Chatbot on COVID-19 Vaccine Perceptions and Intentions
Vaccine hesitancy also concerns healthcare workers (HCWs). However, HCWs are at the frontline of the COVID-19 pandemic and identified as a priority target group for COVID-19 vaccines. Thus, the identification of interventions likely to improve COVID-19 vaccine attitudes and intentions among HCWs is of interests to increase the vaccine coverage among HCWs. The study hypothesis is that the use of the same chatbot as the one tested in the general population in France could also improve the COVID-19 vaccine intentions and perceptions in HCWs.
Read the detailed description
Most countries face the issue of vaccine hesitancy, with sizeable fractions, or sometimes the majority, of the public opposing some vaccines. The problem is particularly acute in the case of COVID-19 vaccination: first, a high uptake of COVID-19 vaccines is necessary to reach and sustain herd immunity; second, and to the best of our knowledge, no country is currently planning on making COVID-19 vaccination mandatory, making public approval essential. Unfortunately, hesitancy towards COVID-19 vaccines is high in many countries. It is therefore crucial that health authorities make it as easy as possible for people who want to be vaccinated to do so, but also that they devise communication strategies to reassure vaccine hesitant individuals. A recent study performed in France (Altay S, et al. 2021) introduced a novel messaging strategy: the use of a chatbot that answers people's questions about COVID-19 vaccines. Results suggest that a properly scripted and regularly updated chatbot could offer a powerful resource to help fight hesitancy towards COVID-19 vaccines.
Vaccine hesitancy also concerns healthcare workers (HCWs). However, HCWs are at the frontline of the COVID-19 pandemic and identified as a priority target group for COVID-19 vaccines. Thus, the identification of tools likely to improve COVID-19 vaccine attitudes and intentions among HCWs is of interests to increase the vaccine coverage among HCWs. The study hypothesis is that the use of the same chatbot as the one tested in the general population in France could also improve the COVID-19 vaccine intentions and perceptions in HCWs.
The primary objective will be to evaluate the short impact of the use of a chatbot on the evolution of the COVID-19 vaccine perceptions in HCWs.
The secondary objectives will be:
- To evaluate the impact at 15-days of the use of a chatbot on the evolution of the COVID-19 vaccine perceptions in HCWs.
- To evaluate the short and at 15-days impact of the use of a chatbot on the evolution of the COVID-19 vaccine intentions in HCWs globally and by vaccine.
- To describe the chatbot connection rate, the interaction time with the chatbot and feedback from the device
These objectives (primary and secondary) will be decline in the sub-groups of caregivers and non-caregivers.
The study population will be made up of HCWs from the ESPERES cohort. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare (i.e. individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as administrative office, housekeeping, food service, etc.).
It is a randomized, two-arm, open label, parallel trial. Participants will be asked to answer a new questionnaire on their COVID-19 vaccine intention and perception, 15 days after their inclusion in the ESPERES cohort. Participants in ESPERES cohort who meet the eligibility criteria for the trial evaluating the chatbot will be randomized into 2 arms: access to the chatbot (intervention group) or access to simple information (control group). Randomization will be carried out at a 1:1 ratio, on blocks of four, stratified on the caregiver/non-caregiver group and the health facility. Randomization will be done online which ensures allocation concealment. Depending on the randomization group, participants access the chatbot or simple information. They can consult them as long as they wish. Participants will be contacted immediately after the first connection to the chatbot and again 15-days later to complete questionnaires on their COVID-19 vaccine hesitancy and perception.
The statistical analyses planned in the research protocol and those responding to specific subsequent studies nested in ESPERES and validated by the scientific committee, will be performed by the pharmaco-epidemiology center (CEPHEPI), under the responsibility of Dr Candice ESTELLAT and Pr Florence TUBACH. The CEPHEPI is backed by the public health department of the hospital group Pitié-Salpêtrière - Charles Foix, AP-HP.
- Conditions
- Healthcare Workers, Covid19
- Being tested
- Chatbot on COVID-19 vaccine hesitancy, Control intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chatbot on COVID-19 vaccine hesitancyDevice
This intervention will provide to participants information on COVID-19 vaccine hesitancy consisting of the possibility of accessing a long series of questions and answers online about this vaccination.
Control interventionOther
This control intervention will provide to participants a brief text decribing the way vaccines works.
| Study group | Role | What they receive |
|---|---|---|
| Chatbot condition | Experimental | Participants randomly assigned to this arm will access to a Chatbot condition, in which they had the opportunity to interact with the chatbot on COVID-19 vaccine hesitancy. Receives: Device: Chatbot on COVID-19 vaccine hesitancy |
| Control condition | Active comparator | Participants randomly assigned to this arm will access to a brief text describing the way vaccines work. Receives: Other: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the COVID-19 vaccine perceptions (5 questions) using a seven-point Likert scale, immediately after the access to the intervention
- "I think vaccines against COVID-19 are safe"
- "I think vaccines against COVID-19 are effective"
- "I think we know enough about the COVID-19 vaccines"
- "I think we can trust the people who produce the COVID-19 vaccines"
- "I think it is important to get vaccinated against COVID-19". The COVID-19 vaccine perceptions variable is the mean of the response to these five questions, each answered on a 7-point likert scale.
Measured: Change from baseline to immediately after intervention (experimental or control arm)
Secondary outcomes (5)
The change in the COVID-19 vaccine perceptions (5 questions) using a seven-point Likert scale, 15-days after the access to the intervention
- "I think vaccines against COVID-19 are safe"
- "I think vaccines against COVID-19 are effective"
- "I think we knowenough about theCOVID-19 vaccines"
- "I think we can trust the people who produce the COVID-19 vaccines"
- "I think it is important to get vaccinated against COVID-19". The COVID-19 vaccine perceptions variable is the mean of the response to these five questions, each answered on a 7-point likert scale.
Measured: From baseline to day 15
The change in the COVID-19 vaccine intention, immediately after the access to the intervention with the following question: "Do you personally intent to be vaccinated against COVID-19?"
- yes, as soon as possible
- yes but I prefer to wait
- no
Measured: From baseline to immediately after the intervention (experimental or control arm)
The change in the COVID-19 vaccine intention, 15 days after the access to the intervention with the following question: "Do you personally intent to be vaccinated against COVID-19?" (yes, as soon as possible / yes but I prefer to wait / no)
- yes, as soon as possible
- yes but I prefer to wait
- no
Measured: From baseline to day 15 after the intervention (experimental or control arm)
Changes into the attitudes and intention towards the COVID-19 vaccines according to the vaccine immediately and 15-days after the access to the interventions
Changes in self-reported attitudes and intention towards the COVID-19 vaccines
Measured: Up to 15 days
Participants in the Chatbot intervention will be ask, after the access to the intervention, to answer to a satisfaction questionnaire
Participants in the Chatbot intervention will be asked whether they had been able to access the chatbot, whether the Chatbot was intuitive, pleasant, frustrating, whether the information provided in the chatbot were too simple or too complicated, and whether they had unanswered questions that they wish the chatbot had addressed (free text entry).
Measured: End of baseline questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start25 May 2021
- Primary completion23 Sep 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare WorkersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Tubach, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881227
- Sponsor's protocol ID
- APHP210173.2
- Status last verified
- Jun 2022
- First submitted
- 10 May 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ESPERES Prospective Cohort of Healthcare Workers in France: Study on the Impact of a Chatbot on COVID-19 Vaccine Perceptions and Intentions
- ClinicalTrials.gov ID
- NCT04881227
- Acronym / sponsor ID
- APHP210173.2
- Conditions
- Healthcare Workers, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 11 May 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.
Vaccine hesitancy also concerns healthcare workers (HCWs). However, HCWs are at the frontline of the COVID-19 pandemic and identified as a priority target group for COVID-19 vaccines. Thus, the identification of interventions likely to improve COVID-19 vaccine attitudes and intentions among HCWs is of interests to increase the vaccine coverage among HCWs. The study hypothesis is that the use of the same chatbot as the one tested in the general population in France could also improve the COVID-19 vaccine intentions and perceptions in HCWs.
Detailed description
Most countries face the issue of vaccine hesitancy, with sizeable fractions, or sometimes the majority, of the public opposing some vaccines. The problem is particularly acute in the case of COVID-19 vaccination: first, a high uptake of COVID-19 vaccines is necessary to reach and sustain herd immunity; second, and to the best of our knowledge, no country is currently planning on making COVID-19 vaccination mandatory, making public approval essential. Unfortunately, hesitancy towards COVID-19 vaccines is high in many countries. It is therefore crucial that health authorities make it as easy as possible for people who want to be vaccinated to do so, but also that they devise communication strategies to reassure vaccine hesitant individuals. A recent study performed in France (Altay S, et al. 2021) introduced a novel messaging strategy: the use of a chatbot that answers people's questions about COVID-19 vaccines. Results suggest that a properly scripted and regularly updated chatbot could offer a powerful resource to help fight hesitancy towards COVID-19 vaccines.
Vaccine hesitancy also concerns healthcare workers (HCWs). However, HCWs are at the frontline of the COVID-19 pandemic and identified as a priority target group for COVID-19 vaccines. Thus, the identification of tools likely to improve COVID-19 vaccine attitudes and intentions among HCWs is of interests to increase the vaccine coverage among HCWs. The study hypothesis is that the use of the same chatbot as the one tested in the general population in France could also improve the COVID-19 vaccine intentions and perceptions in HCWs.
The primary objective will be to evaluate the short impact of the use of a chatbot on the evolution of the COVID-19 vaccine perceptions in HCWs.
The secondary objectives will be:
- To evaluate the impact at 15-days of the use of a chatbot on the evolution of the COVID-19 vaccine perceptions in HCWs.
- To evaluate the short and at 15-days impact of the use of a chatbot on the evolution of the COVID-19 vaccine intentions in HCWs globally and by vaccine.
- To describe the chatbot connection rate, the interaction time with the chatbot and feedback from the device
These objectives (primary and secondary) will be decline in the sub-groups of caregivers and non-caregivers.
The study population will be made up of HCWs from the ESPERES cohort. For the purposes of this study, a "healthcare worker" is defined as an individual who currently works in a setting where individuals receive healthcare (i.e. individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as administrative office, housekeeping, food service, etc.).
It is a randomized, two-arm, open label, parallel trial. Participants will be asked to answer a new questionnaire on their COVID-19 vaccine intention and perception, 15 days after their inclusion in the ESPERES cohort. Participants in ESPERES cohort who meet the eligibility criteria for the trial evaluating the chatbot will be randomized into 2 arms: access to the chatbot (intervention group) or access to simple information (control group). Randomization will be carried out at a 1:1 ratio, on blocks of four, stratified on the caregiver/non-caregiver group and the health facility. Randomization will be done online which ensures allocation concealment. Depending on the randomization group, participants access the chatbot or simple information. They can consult them as long as they wish. Participants will be contacted immediately after the first connection to the chatbot and again 15-days later to complete questionnaires on their COVID-19 vaccine hesitancy and perception.
The statistical analyses planned in the research protocol and those responding to specific subsequent studies nested in ESPERES and validated by the scientific committee, will be performed by the pharmaco-epidemiology center (CEPHEPI), under the responsibility of Dr Candice ESTELLAT and Pr Florence TUBACH. The CEPHEPI is backed by the public health department of the hospital group Pitié-Salpêtrière - Charles Foix, AP-HP.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chatbot condition | Experimental | Device: Chatbot on COVID-19 vaccine hesitancyParticipants randomly assigned to this arm will access to a Chatbot condition, in which they had the opportunity to interact with the chatbot on COVID-19 vaccine hesitancy. |
| Control condition | Active comparator | Other: Control interventionParticipants randomly assigned to this arm will access to a brief text describing the way vaccines work. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Legal age
- Healthcare workers defined as individuals who currently work in a setting where individuals receive healthcare (i.e. individuals do not have to work directly with patients, but may have any role within a setting where individuals receive healthcare, such as administrative office, housekeeping, food service, etc.)
- Included in ESPERES cohort and with the initial questionnaire completed
- Agreeing to participate (digital consent)
Key exclusion criteria (2 listed)
- No internet access
- Vaccinated against COVID-19 (at least one dose)
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 on COVID-19 vaccine hesitancyThis intervention will provide to participants information on COVID-19 vaccine hesitancy consisting of the possibility of accessing a long series of questions and answers online about this vaccination. | Device | Chatbot condition |
| Control interventionThis control intervention will provide to participants a brief text decribing the way vaccines works. | Other | Control condition |
Primary outcome
The change in the COVID-19 vaccine perceptions (5 questions) using a seven-point Likert scale, immediately after the access to the intervention
Time frame: Change from baseline to immediately after intervention (experimental or control arm)
1. "I think vaccines against COVID-19 are safe" 2. "I think vaccines against COVID-19 are effective" 3. "I think we know enough about the COVID-19 vaccines" 4. "I think we can trust the people who produce the COVID-19 vaccines" 5. "I think it is important to get vaccinated against COVID-19". The COVID-19 vaccine perceptions variable is the mean of the response to these five questions, each answered on a 7-point likert scale.
5 secondary outcomes
The change in the COVID-19 vaccine perceptions (5 questions) using a seven-point Likert scale, 15-days after the access to the intervention
Time frame: From baseline to day 15
The change in the COVID-19 vaccine intention, immediately after the access to the intervention with the following question: "Do you personally intent to be vaccinated against COVID-19?"
Time frame: From baseline to immediately after the intervention (experimental or control arm)
The change in the COVID-19 vaccine intention, 15 days after the access to the intervention with the following question: "Do you personally intent to be vaccinated against COVID-19?" (yes, as soon as possible / yes but I prefer to wait / no)
Time frame: From baseline to day 15 after the intervention (experimental or control arm)
Changes into the attitudes and intention towards the COVID-19 vaccines according to the vaccine immediately and 15-days after the access to the interventions
Time frame: Up to 15 days
Participants in the Chatbot intervention will be ask, after the access to the intervention, to answer to a satisfaction questionnaire
Time frame: End of baseline questionnaire
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 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Florence Tubach, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 on COVID-19 vaccine hesitancy in people with Healthcare Workers and Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 2 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 21 Jun 2022. 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 France. 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?
The change in the COVID-19 vaccine perceptions (5 questions) using a seven-point Likert scale, immediately after the access to the intervention (time frame: Change from baseline to immediately after intervention (experimental or control arm)). 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 21 Jun 2022.