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

University Hospital Center (CHU)

Status: Completed

Conditions: Asthma

Treatments: Other: Chatbot patient education; Other: Standard patient education

Study type: Interventional

Funder types: Other

Identifiers

NCT05248126

RECHMPL21_0423 - UF7779

2021-A02205-36 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Comparator arm

Active Comparator group

Description:

All patients randomized to this arm will participate in a standard patient education program.

Treatment:

Other: Standard patient education

Experimental arm

Experimental group

Description:

All patients randomised to this arm have the opportunity to participate in a patient education programme via a chatbot.

Treatment:

Other: Chatbot patient education