Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients
- Conditions
- Asthma
- Interventions
- Other: Chatbot patient educationOther: Standard patient education
- Registration Number
- NCT05248126
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- Minimum age: 18
- Physician-confirmed diagnosis of asthma
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental arm Chatbot patient education All patients randomised to this arm have the opportunity to participate in a patient education programme via a chatbot. Comparator arm Standard patient education All patients randomized to this arm will participate in a standard patient education program.
- Primary Outcome Measures
Name Time Method Change in the total AQLQ score 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 Outcome Measures
Name Time Method Cumulative number of telephone calls to/from the patient baseline to 6 months The cumulative dose for oral corticosteroids baseline to 6 months Change in the 'symptoms' domain of the AQLQ from baseline to six months 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.
Change in the EQ-5D-5L score 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.
Percentage of patients participating in the 6 month visit 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 nursing consults baseline to 6 months Accumulating numbers of days of hospitalization (in relation to asthma) baseline to 6 months Change in the 'environmental exposure' domain of the AQLQ from baseline to six months 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.
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 For the experimental arm only, weeks of chatbot usage baseline to 6 months The cumulative dose for short acting muscarinic antagonists baseline to 6 months Change in the 'activity limitation' domain of the AQLQ from baseline to six months 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.
Change in the 'emotional function' domain of the AQLQ from baseline to six months 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.
Change in FEV1/FVC ratios (litres/litres) baseline to 6 months The cumulative dose for long acting muscarinic antagonists baseline to 6 months Accumulating numbers of specialist consults baseline to 6 months Accumulating numbers of unexpected/emergency consults baseline to 6 months Accumulating numbers of days of exacerbation baseline to 6 months Change in the ACQ-5 score 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.
Cumulative number of emails 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 Accumulating numbers of generalist consults baseline to 6 months Accumulating numbers of days of intensive care (in relation to asthma) baseline to 6 months
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Montpellier
🇫🇷Montpellier, France