Skip to main content
OpenTrials
Completed

NCT Number: NCT05248126

Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimum age: 18
  • Physician-confirmed diagnosis of asthma

Exclusion criteria

  • 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

Treatment and study plan

Standard Patient Education

Other

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 education

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in the 'symptoms' domain of the AQLQ from baseline to six months

    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.

  2. Change in the 'activity limitation' domain of the AQLQ from baseline to six months

    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.

  3. Change in the 'emotional function' domain of the AQLQ from baseline to six months

    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.

  4. Change in the 'environmental exposure' domain of the AQLQ from baseline to six months

    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.

  5. Change in the ACQ-5 score

    Time frame: baseline to 6 months

    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.

  6. Change in %predicted values of forced expiratory volume in 1 second (FEV1)

    Time frame: baseline to 6 months

  7. Change in %predicted values of forced vital capacity (FVC)

    Time frame: baseline to 6 months

  8. Change in FEV1/FVC ratios (litres/litres)

    Time frame: baseline to 6 months

  9. Change in the EQ-5D-5L score

    Time frame: baseline to 6 months

    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.

  10. Percentage of patients participating in the 6 month visit

    Time frame: 6 months

  11. For the experimental arm only, weeks of chatbot usage

    Time frame: baseline to 6 months

  12. Cumulative number of emails to/from the patient

    Time frame: baseline to 6 months

  13. Cumulative number of telephone calls to/from the patient

    Time frame: baseline to 6 months

  14. The cumulative dose for short-acting beta antagonists

    Time frame: baseline to 6 months

  15. The cumulative dose for long acting beta antagonists

    Time frame: baseline to 6 months

  16. The cumulative dose for short acting muscarinic antagonists

    Time frame: baseline to 6 months

  17. The cumulative dose for long acting muscarinic antagonists

    Time frame: baseline to 6 months

  18. The cumulative dose for oral corticosteroids

    Time frame: baseline to 6 months

  19. The cumulative dose for inhaled corticosteroids

    Time frame: baseline to 6 months

  20. The cumulative dose for nasal corticosteroids

    Time frame: baseline to 6 months

  21. Accumulating numbers of generalist consults

    Time frame: baseline to 6 months

  22. Accumulating numbers of specialist consults

    Time frame: baseline to 6 months

  23. Accumulating numbers of nursing consults

    Time frame: baseline to 6 months

  24. Accumulating numbers of unexpected/emergency consults

    Time frame: baseline to 6 months

  25. Accumulating numbers of days of hospitalization (in relation to asthma)

    Time frame: baseline to 6 months

  26. Accumulating numbers of days of intensive care (in relation to asthma)

    Time frame: baseline to 6 months

  27. Accumulating numbers of days of exacerbation

    Time frame: baseline to 6 months

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: AsthmaTrain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.