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NCT05248126 | COMPLETED | Asthma


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

Condition or disease

Asthma

Intervention/treatment

Standard patient education

Chatbot patient education

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 73 participants
Masking : NONE
Masking Description : 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.
Primary Purpose : SUPPORTIVE_CARE
Official Title : Standard Patient Training Versus Vik Chatbot Guided Training: a Randomized Controlled Trial for Asthma Patients
Actual Study Start Date : 2022-05-24
Estimated Primary Completion Date : 2023-10-27
Estimated Study Completion Date : 2023-10-27

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT05248126


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How to Participate

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Locations


Not yet recruiting

France,

Montpellier University Hospital Center

Montpellier, France, 34295

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