Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Change in the total AQLQ score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This protocol aims to compare two different ways of engaging with the patient and teaching. The notion of blinding per se is not adapted to this protocol, which is carried out, for all practical purposes, in an "open" fashion. Nevertheless, the Zelen randomisation procedure, which aims to maintain the comparator arm ignorant of the existence of the experimental arm in order to avoid "resentful demoralisation" effects, may also result in a partial blinding effect.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age: 18
- •Physician-confirmed diagnosis of asthma
排除标准
- •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
研究组 & 干预措施
Comparator arm
All patients randomized to this arm will participate in a standard patient education program.
干预措施: Standard patient education (Other)
Experimental arm
All patients randomised to this arm have the opportunity to participate in a patient education programme via a chatbot.
干预措施: Chatbot patient education (Other)
结局指标
主要结局
Change in the total AQLQ score
时间窗: 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.
次要结局
- Cumulative number of emails to/from the patient(baseline to 6 months)
- The cumulative dose for short-acting beta antagonists(baseline to 6 months)
- Change in the 'symptoms' domain of the AQLQ from baseline to six months(baseline to 6 months)
- 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 EQ-5D-5L score(baseline to 6 months)
- 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)
- 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)
- Change in the 'emotional function' domain of the AQLQ from baseline to six months(baseline to 6 months)
- 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 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)