Clinical trial NCT05248126: Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients
Official title: Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: chatbot
patient education
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the total AQLQ score
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Change in the 'symptoms' domain of the AQLQ from baseline to six months
timeFrame: baseline to 6 months
measure: Change in the 'activity limitation' domain of the AQLQ from baseline to six months
timeFrame: baseline to 6 months
measure: Change in the 'emotional function' domain of the AQLQ from baseline to six months
timeFrame: baseline to 6 months
measure: Change in the 'environmental exposure' domain of the AQLQ from baseline to six months
timeFrame: baseline to 6 months
measure: Change in the ACQ-5 score
timeFrame: baseline to 6 months
measure: Change in %predicted values of forced expiratory volume in 1 second (FEV1)
timeFrame: baseline to 6 months
measure: Change in %predicted values of forced vital capacity (FVC)
timeFrame: baseline to 6 months
measure: Change in FEV1/FVC ratios (litres/litres)
timeFrame: baseline to 6 months
measure: Change in the EQ-5D-5L score
timeFrame: baseline to 6 months
measure: Percentage of patients participating in the 6 month visit
timeFrame: 6 months
measure: For the experimental arm only, weeks of chatbot usage
timeFrame: baseline to 6 months
measure: Cumulative number of emails to/from the patient
timeFrame: baseline to 6 months
measure: Cumulative number of telephone calls to/from the patient
timeFrame: baseline to 6 months
measure: The cumulative dose for short-acting beta antagonists
timeFrame: baseline to 6 months
measure: The cumulative dose for long acting beta antagonists
timeFrame: baseline to 6 months
measure: The cumulative dose for short acting muscarinic antagonists
timeFrame: baseline to 6 months
measure: The cumulative dose for long acting muscarinic antagonists
timeFrame: baseline to 6 months
measure: The cumulative dose for oral corticosteroids
timeFrame: baseline to 6 months
measure: The cumulative dose for inhaled corticosteroids
timeFrame: baseline to 6 months
measure: The cumulative dose for nasal corticosteroids
timeFrame: baseline to 6 months
measure: Accumulating numbers of generalist consults
timeFrame: baseline to 6 months
measure: Accumulating numbers of specialist consults
timeFrame: baseline to 6 months
measure: Accumulating numbers of nursing consults
timeFrame: baseline to 6 months
measure: Accumulating numbers of unexpected/emergency consults
timeFrame: baseline to 6 months
measure: Accumulating numbers of days of hospitalization (in relation to asthma)
timeFrame: baseline to 6 months
measure: Accumulating numbers of days of intensive care (in relation to asthma)
timeFrame: baseline to 6 months
measure: Accumulating numbers of days of exacerbation
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Arnaud Bourdin, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.