AsthmaAsthmaTrainNCT05248126
Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients
A study testing Standard patient education and Chatbot patient education in people with Asthma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The onset of smartphone usage has provided new opportunities for managing patients outside the walls of healthcare facilities. The development of asthma-specific smartphone applications represents an excellent area for partnership between developers and medical teams for delivering therapeutic education at the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Standard patient education and Chatbot patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 24 May 2022to 27 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age: 18
- Physician-confirmed diagnosis of asthma
Who cannot join
- Protected populations according to the French Public Health Code Articles L1121-6,8
- The subject has already participated in the present study
- Subject unable to comply with trial procedures/visits
- Potential for interference from another study
- Non-beneficiary of the French single-payer national medical insurance system
- Lack of informed consent
- Patients already using the Vik Asthma application in their daily lives or having already followed a therapeutic education program
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
About this study
The onset of smartphone usage has provided new opportunities for managing patients outside the walls of healthcare facilities. The development of asthma-specific smartphone applications represents an excellent area for partnership between developers and medical teams for delivering therapeutic education at the required time and in a personalised way. Within this context, the overall goal of the AsthmaTrain study is to perform a first, small pilot study comparing a new French-language chat-bot guided asthma patient education programme (the 'Vik' application) with the classic, authority-approved patient education program at the University Hospitals of Montpellier, Montpellier, France.
The primary objective is to compare a population of adult patients with asthma and participating in a standard patient education programme with a similar population participating in Vik-guided education programme in terms of change in overall scores on the Asthma Quality of Life Questionnaire (AQLQ).
Read the detailed description
Secondarily, the following will also be compared between the two study arms:
- the subdomains of the AQLQ score,
- lung function, overall asthma control and exacerbation rates,
- general health status via the Euroqol 5-domain 5-level questionnaire (EQ-5D-5L),
- adherence to the program and burden of the program for the medical team,
- major categories of direct health resource consumption.
Finally, because education intervention success may depend on patient-specific characteristics, an ancillary study will compare the following baseline traits between the 50% best intervention responders in either arm:
- the big five personality traits,
- the hospital anxiety and depression,
- coping mechanisms.
- Conditions
- Asthma
- Being tested
- Standard patient education, Chatbot patient education
- Keywords
- chatbot, patient education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard patient educationOther
The comparator intervention is the usual therapeutic training for patients (ETP) cursus currently used in the General Pulmonology unit at the Arnaud De Villeneuve Hospital, Montpellier, France and approved by the French Regional Health Authority for the Occitanie Region [Agence Régional de Santé Occitanie].
Chatbot patient educationOther
The experimental intervention consists in providing the patient with access to a specific version of the "Vik-Asthme" chat bot for the duration of the study. Should the patient be unable to use or refuse to use the chatbot, the reasons for refusal will be documented and the patient will proceed with the comparator intervention.
| Study group | Role | What they receive |
|---|---|---|
| Comparator arm | Active comparator | All patients randomized to this arm will participate in a standard patient education program. Receives: Other: Standard patient education |
| Experimental arm | Experimental | All patients randomised to this arm have the opportunity to participate in a patient education programme via a chatbot. Receives: Other: Chatbot patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total AQLQ score
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain instrument that can either be self- or interviewer-administered. The recall-time is two weeks. The four domains covered are: (i) symptoms (11 items), (ii) activity limitation (12 items, 5 of which are individualized), (iii) emotional function (5 items), and (iv) environmental exposure (4 items). Each item is ranked by the patient using a 7-point Likert scale ranging from 1 (severely impaired) to 7 (not impaired at all). Scores range from 1 to 7, higher scores indicate better quality of life and a minimally important difference (for overall scores and for each sub-domain) has been established at 0.5.
Measured: baseline to 6 months
Secondary outcomes (27)
Change in the 'symptoms' domain of the AQLQ from baseline to six months
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain instrument that can either be self- or interviewer-administered. The recall-time is two weeks. The four domains covered are: (i) symptoms (11 items), (ii) activity limitation (12 items, 5 of which are individualized), (iii) emotional function (5 items), and (iv) environmental exposure (4 items). Each item is ranked by the patient using a 7-point Likert scale ranging from 1 (severely impaired) to 7 (not impaired at all). Scores range from 1 to 7, higher scores indicate better quality of life and a minimally important difference (for overall scores and for each sub-domain) has been established at 0.5.
Measured: baseline to 6 months
Change in the 'activity limitation' domain of the AQLQ from baseline to six months
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain instrument that can either be self- or interviewer-administered. The recall-time is two weeks. The four domains covered are: (i) symptoms (11 items), (ii) activity limitation (12 items, 5 of which are individualized), (iii) emotional function (5 items), and (iv) environmental exposure (4 items). Each item is ranked by the patient using a 7-point Likert scale ranging from 1 (severely impaired) to 7 (not impaired at all). Scores range from 1 to 7, higher scores indicate better quality of life and a minimally important difference (for overall scores and for each sub-domain) has been established at 0.5.
Measured: baseline to 6 months
Change in the 'emotional function' domain of the AQLQ from baseline to six months
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain instrument that can either be self- or interviewer-administered. The recall-time is two weeks. The four domains covered are: (i) symptoms (11 items), (ii) activity limitation (12 items, 5 of which are individualized), (iii) emotional function (5 items), and (iv) environmental exposure (4 items). Each item is ranked by the patient using a 7-point Likert scale ranging from 1 (severely impaired) to 7 (not impaired at all). Scores range from 1 to 7, higher scores indicate better quality of life and a minimally important difference (for overall scores and for each sub-domain) has been established at 0.5.
Measured: baseline to 6 months
Change in the 'environmental exposure' domain of the AQLQ from baseline to six months
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain instrument that can either be self- or interviewer-administered. The recall-time is two weeks. The four domains covered are: (i) symptoms (11 items), (ii) activity limitation (12 items, 5 of which are individualized), (iii) emotional function (5 items), and (iv) environmental exposure (4 items). Each item is ranked by the patient using a 7-point Likert scale ranging from 1 (severely impaired) to 7 (not impaired at all). Scores range from 1 to 7, higher scores indicate better quality of life and a minimally important difference (for overall scores and for each sub-domain) has been established at 0.5.
Measured: baseline to 6 months
Change in the ACQ-5 score
The ACQ-5 is a shortened version of the ACQ that assesses asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) omitting the forced expiratory volume in 1 second measurement and short acting beta antagonist use from the original ACQ score. Patients are asked to recall how their asthma has been during the previous week by responding to 5 symptom questions. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-5 score is the mean of the responses. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and <1.5 indicate partly controlled asthma, and a score ≥1.5 indicates not well controlled asthma . Individual changes of at least 0.5 are considered to be clinically meaningful.
Measured: baseline to 6 months
Change in %predicted values of forced expiratory volume in 1 second (FEV1)
Measured: baseline to 6 months
Change in %predicted values of forced vital capacity (FVC)
Measured: baseline to 6 months
Change in FEV1/FVC ratios (litres/litres)
Measured: baseline to 6 months
Change in the EQ-5D-5L score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Measured: baseline to 6 months
Percentage of patients participating in the 6 month visit
Measured: 6 months
For the experimental arm only, weeks of chatbot usage
Measured: baseline to 6 months
Cumulative number of emails to/from the patient
Measured: baseline to 6 months
Cumulative number of telephone calls to/from the patient
Measured: baseline to 6 months
The cumulative dose for short-acting beta antagonists
Measured: baseline to 6 months
The cumulative dose for long acting beta antagonists
Measured: baseline to 6 months
The cumulative dose for short acting muscarinic antagonists
Measured: baseline to 6 months
The cumulative dose for long acting muscarinic antagonists
Measured: baseline to 6 months
The cumulative dose for oral corticosteroids
Measured: baseline to 6 months
The cumulative dose for inhaled corticosteroids
Measured: baseline to 6 months
The cumulative dose for nasal corticosteroids
Measured: baseline to 6 months
Accumulating numbers of generalist consults
Measured: baseline to 6 months
Accumulating numbers of specialist consults
Measured: baseline to 6 months
Accumulating numbers of nursing consults
Measured: baseline to 6 months
Accumulating numbers of unexpected/emergency consults
Measured: baseline to 6 months
Accumulating numbers of days of hospitalization (in relation to asthma)
Measured: baseline to 6 months
Accumulating numbers of days of intensive care (in relation to asthma)
Measured: baseline to 6 months
Accumulating numbers of days of exacerbation
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start24 May 2022
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, randomized (1:1), controlled, pilot trial with a single-Zelen consent procedure will compare changes in quality of life, asthma control, lung function and health resource consumption between one group of patients with asthma participating in a classic treatment education program (the "standard education" arm) with a similar, second group of patients participating in a novel, chatbot-guided treatment education program (the "Vik" arm).
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Bourdin, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248126
- Sponsor's protocol ID
- RECHMPL21_0423 - UF7779
- Other IDs
- 2021-A02205-36
- Acronym
- AsthmaTrain
- Status last verified
- Jan 2024
- First submitted
- 9 Feb 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data will be made available to persons who address a reasonable request to the study director. Individual participant data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. The study protocol, participant information materials, and paper case report form will also be made available to the public.
Publications
Suehs CM, Vachier I, Galeazzi D, Vaast F, Cardon F, Molinari N, Bourdin A. Standard patient training versus Vik-Asthme chatbot-guided training: 'AsthmaTrain' - a protocol for a randomised controlled trial for patients with asthma. BMJ Open. 2023 Feb 21;13(2):e067039. doi: 10.1136/bmjopen-2022-067039.
PubMed 36810168Bourdin A, Casanova S, Ahmed E, Brouard B, Boher A, Vachier I, Suehs C, Pujot F, Nogue E, Galeazzi D, Cardon F, Volpato M, Halimi L, Skinner S, Molinari N. Larger quality-of-life gains with an asthma support app: a randomised controlled trial. ERJ Open Res. 2025 Nov 10;11(6):00361-2025. doi: 10.1183/23120541.00361-2025. eCollection 2025 Nov.
PubMed 41220823
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients
- ClinicalTrials.gov ID
- NCT05248126
- Acronym / sponsor ID
- AsthmaTrain / RECHMPL21_0423 - UF7779
- Conditions
- Asthma
- Keywords
- chatbot, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 21 Feb 2022 (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.
The onset of smartphone usage has provided new opportunities for managing patients outside the walls of healthcare facilities. The development of asthma-specific smartphone applications represents an excellent area for partnership between developers and medical teams for delivering therapeutic education at the required time and in a personalised way. Within this context, the overall goal of the AsthmaTrain study is to perform a first, small pilot study comparing a new French-language chat-bot guided asthma patient education programme (the 'Vik' application) with the classic, authority-approved patient education program at the University Hospitals of Montpellier, Montpellier, France.
The primary objective is to compare a population of adult patients with asthma and participating in a standard patient education programme with a similar population participating in Vik-guided education programme in terms of change in overall scores on the Asthma Quality of Life Questionnaire (AQLQ).
Detailed description
Secondarily, the following will also be compared between the two study arms:
- the subdomains of the AQLQ score,
- lung function, overall asthma control and exacerbation rates,
- general health status via the Euroqol 5-domain 5-level questionnaire (EQ-5D-5L),
- adherence to the program and burden of the program for the medical team,
- major categories of direct health resource consumption.
Finally, because education intervention success may depend on patient-specific characteristics, an ancillary study will compare the following baseline traits between the 50% best intervention responders in either arm:
- the big five personality traits,
- the hospital anxiety and depression,
- coping mechanisms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective, randomized (1:1), controlled, pilot trial with a single-Zelen consent procedure will compare changes in quality of life, asthma control, lung function and health resource consumption between one group of patients with asthma participating in a classic treatment education program (the "standard education" arm) with a similar, second group of patients participating in a novel, chatbot-guided treatment education program (the "Vik" arm).
| Arm | Type | Receives |
|---|---|---|
| Comparator arm | Active comparator | Other: Standard patient educationAll patients randomized to this arm will participate in a standard patient education program. |
| Experimental arm | Experimental | Other: Chatbot patient educationAll patients randomised to this arm have the opportunity to participate in a patient education programme via a chatbot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Minimum age: 18
- Physician-confirmed diagnosis of asthma
Key exclusion criteria (7 listed)
- Protected populations according to the French Public Health Code Articles L1121-6,8
- The subject has already participated in the present study
- Subject unable to comply with trial procedures/visits
- Potential for interference from another study
- Non-beneficiary of the French single-payer national medical insurance system
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 |
|---|---|---|
| Standard patient educationThe comparator intervention is the usual therapeutic training for patients (ETP) cursus currently used in the General Pulmonology unit at the Arnaud De Villeneuve Hospital, Montpellier, France and approved by the French Regional Health Authority for the Occitanie Region [Agence Régional de Santé Occitanie]. | Other | Comparator arm |
| Chatbot patient educationThe experimental intervention consists in providing the patient with access to a specific version of the "Vik-Asthme" chat bot for the duration of the study. Should the patient be unable to use or refuse to use the chatbot, the reasons for refusal will be documented and the patient will proceed with the comparator intervention. | Other | Experimental arm |
Primary outcome
Change in the total AQLQ score
Time frame: baseline to 6 months
The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item, 4-domain instrument that can either be self- or interviewer-administered. The recall-time is two weeks. The four domains covered are: (i) symptoms (11 items), (ii) activity limitation (12 items, 5 of which are individualized), (iii) emotional function (5 items), and (iv) environmental exposure (4 items). Each item is ranked by the patient using a 7-point Likert scale ranging from 1 (severely impaired) to 7 (not impaired at all). Scores range from 1 to 7, higher scores indicate better quality of life and a minimally important difference (for overall scores and for each sub-domain) has been established at 0.5.
27 secondary outcomes
Change in the 'symptoms' domain of the AQLQ from baseline to six months
Time frame: baseline to 6 months
Change in the 'activity limitation' domain of the AQLQ from baseline to six months
Time frame: baseline to 6 months
Change in the 'emotional function' domain of the AQLQ from baseline to six months
Time frame: baseline to 6 months
Change in the 'environmental exposure' domain of the AQLQ from baseline to six months
Time frame: baseline to 6 months
Change in the ACQ-5 score
Time frame: baseline to 6 months
Change in %predicted values of forced expiratory volume in 1 second (FEV1)
Time frame: baseline to 6 months
Change in %predicted values of forced vital capacity (FVC)
Time frame: baseline to 6 months
Change in FEV1/FVC ratios (litres/litres)
Time frame: baseline to 6 months
Change in the EQ-5D-5L score
Time frame: baseline to 6 months
Percentage of patients participating in the 6 month visit
Time frame: 6 months
For the experimental arm only, weeks of chatbot usage
Time frame: baseline to 6 months
Cumulative number of emails to/from the patient
Time frame: baseline to 6 months
Cumulative number of telephone calls to/from the patient
Time frame: baseline to 6 months
The cumulative dose for short-acting beta antagonists
Time frame: baseline to 6 months
The cumulative dose for long acting beta antagonists
Time frame: baseline to 6 months
The cumulative dose for short acting muscarinic antagonists
Time frame: baseline to 6 months
The cumulative dose for long acting muscarinic antagonists
Time frame: baseline to 6 months
The cumulative dose for oral corticosteroids
Time frame: baseline to 6 months
The cumulative dose for inhaled corticosteroids
Time frame: baseline to 6 months
The cumulative dose for nasal corticosteroids
Time frame: baseline to 6 months
Accumulating numbers of generalist consults
Time frame: baseline to 6 months
Accumulating numbers of specialist consults
Time frame: baseline to 6 months
Accumulating numbers of nursing consults
Time frame: baseline to 6 months
Accumulating numbers of unexpected/emergency consults
Time frame: baseline to 6 months
Accumulating numbers of days of hospitalization (in relation to asthma)
Time frame: baseline to 6 months
Accumulating numbers of days of intensive care (in relation to asthma)
Time frame: baseline to 6 months
Accumulating numbers of days of exacerbation
Time frame: baseline to 6 months
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 12 Jun 2026.
- Background: PubMed 36810168Suehs CM, Vachier I, Galeazzi D, Vaast F, Cardon F, Molinari N, Bourdin A. Standard patient training versus Vik-Asthme chatbot-guided training: 'AsthmaTrain' - a protocol for a randomised controlled trial for patients with asthma. BMJ Open. 2023 Feb 21;13(2):e067039. doi: 10.1136/bmjopen-2022-067039.
- Results publication: PubMed 41220823Bourdin A, Casanova S, Ahmed E, Brouard B, Boher A, Vachier I, Suehs C, Pujot F, Nogue E, Galeazzi D, Cardon F, Volpato M, Halimi L, Skinner S, Molinari N. Larger quality-of-life gains with an asthma support app: a randomised controlled trial. ERJ Open Res. 2025 Nov 10;11(6):00361-2025. doi: 10.1183/23120541.00361-2025. eCollection 2025 Nov.
- Individual participant dataSharing planned: Yes. The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data will be made available to persons who address a reasonable request to the study director. Individual participant data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. The study protocol, participant information materials, and paper case report form will also be made available to the public.
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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.
Arnaud Bourdin, MD, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard patient education and Chatbot patient education in people with Asthma, run by University Hospital, Montpellier 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 2 inclusion and 7 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 12 Jun 2026. 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?
Change in the total AQLQ score (time frame: baseline to 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 NCT05248126, which also lists 2 linked publications.
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 12 Jun 2026.