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

Asthma Clinical Trial

— AsthmaTrain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248126
• Other study ID #: RECHMPL21_0423 - UF7779
• Secondary ID: 2021-A02205-36
• Status: Completed
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: October 27, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Standard patient education
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
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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

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