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

NCT05248126 | Completed DMC

• 2 other identifiers: RECHMPL21_0423 - UF77792021-A02205-36
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma

Keywords

chatbot; patient education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Change in the 'symptoms' domain of the AQLQ from baseline to six months

  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 the 'environmental exposure' domain of the AQLQ from baseline to six months

  baseline to 6 months

• Change in the ACQ-5 score

  baseline to 6 months

Study Arms (2)

Comparator arm

ACTIVE COMPARATOR

All patients randomized to this arm will participate in a standard patient education program.

Other: Standard patient education

Experimental arm

EXPERIMENTAL

All patients randomised to this arm have the opportunity to participate in a patient education programme via a chatbot.

Other: Chatbot patient education

Interventions

Standard patient education OTHER

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 \[Agence Régional de Santé Occitanie\].

Comparator arm

Chatbot patient education OTHER

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum age: 18
• Physician-confirmed diagnosis of asthma

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

Related 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.

  PMID: 36810168 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Arnaud Bourdin, MD, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 21, 2022
• Study Start: May 24, 2022
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Datasets that underlie the results reported in the article (text, tables, figures, and appendices) can be requested after the publication process has been completed. The protocol will be published in an open-access journal. The remaining documents will be made available on the Open Science Framework as they are finalized.
• Access Criteria: * The data will be used/examined in a not-for-profit manner; * The data will not be used in an attempt to identify a participant or group of participants; * The user does not work for a private insurance company; * The data will not be used in support of any kind of private insurance policy or health penalties; * The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights; * The user will state why they wish to access the data. * If the data do not fulfil the requirements of the reference methodology (MR-001) (ex: data about religion, etc.), the appropriate CNIL (National Commission for Computing and Liberties) approval has to be obtained by the user. * If the data will be used outside the European Union, standard contractual clauses have to be signed between Montpellier University Hospital and the user before sharing data.

Locations

FR (1)