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

Study Overview
=================
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.

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

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: Standard patient education
* Other: Chatbot patient education


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Comparator arm<br>All patients randomized to this arm will participate in a standard patient education program. | Other: Standard patient education<br>* 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].<br>|
| Experimental: Experimental arm<br>All patients randomised to this arm have the opportunity to participate in a patient education programme via a chatbot. | Other: Chatbot patient education<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | baseline to 6 months | 
| Change in %predicted values of forced expiratory volume in 1 second (FEV1) |  | baseline to 6 months | 
| Change in %predicted values of forced vital capacity (FVC) |  | baseline to 6 months | 
| Change in FEV1/FVC ratios (litres/litres) |  | 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. | baseline to 6 months | 
| Percentage of patients participating in the 6 month visit |  | 6 months | 
| For the experimental arm only, weeks of chatbot usage |  | baseline to 6 months | 
| Cumulative number of emails to/from the patient |  | baseline to 6 months | 
| Cumulative number of telephone calls to/from the patient |  | baseline to 6 months | 
| The cumulative dose for short-acting beta antagonists |  | baseline to 6 months | 
| The cumulative dose for long acting beta antagonists |  | baseline to 6 months | 
| The cumulative dose for short acting muscarinic antagonists |  | baseline to 6 months | 
| The cumulative dose for long acting muscarinic antagonists |  | baseline to 6 months | 
| The cumulative dose for oral corticosteroids |  | baseline to 6 months | 
| The cumulative dose for inhaled corticosteroids |  | baseline to 6 months | 
| The cumulative dose for nasal corticosteroids |  | baseline to 6 months | 
| Accumulating numbers of generalist consults |  | baseline to 6 months | 
| Accumulating numbers of specialist consults |  | baseline to 6 months | 
| Accumulating numbers of nursing consults |  | baseline to 6 months | 
| Accumulating numbers of unexpected/emergency consults |  | baseline to 6 months | 
| Accumulating numbers of days of hospitalization (in relation to asthma) |  | baseline to 6 months | 
| Accumulating numbers of days of intensive care (in relation to asthma) |  | baseline to 6 months | 
| Accumulating numbers of days of exacerbation |  | baseline to 6 months | 
| 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. | 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. | baseline to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chatbot, patient education