Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care.

NCT ID: NCT03445507

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 542 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-07
• Study Completion Date: 2020-12-31

Brief Summary

This study aims to evaluate the effectiveness of an intervention to help people to quit smoking throughout an chat bot compared with usual assistance to increase long-term rates of nicotine abstinence in smoking outpatients with biochemical validation at 6 months.

Half of participants(control group) will receive usual care by their usual general practitioners and nurses, and the other half (intervention group) will use an evidence-based chat bot specifically designed to help people quit smoking.

Detailed Description

An array of interventions have been shown to be both cost-effective and efficacious in helping patients quit smoking and so are included in usual care given by general practitioners and nurses. However, in the primary care setting, this sort of interventions are less common than they should be, due to many circunstances, and solutions must be found due to the huge dimensions of tobacco use challenge.

On the other hand,new kinds of information tecnology give a chance to intervene with less costs and more specific tools. Actually, there are a lot of mobile apps and other devices designed to help people to improve their health in many ways, but without scientific evidence of their effects.

This is a pragmatic, randomised, controled and multicentric clinical trial that tries to evaluate in general population the effectiveness of a chat bot that incorporates evidence based interventions and interacts by a text application instaled in patients mobile phone (intervention group).

Investigators have decided to compare with usual care delivered by the usual general practisioners and nurses of Spanish Public Health Centres, because this interventions have shown their effectiveness (control group).

Efficiency and impact on quality of life will also be compared on both groups.

Conditions

Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Use of an evidence-based chat bot for smoking cessation

Group Type: EXPERIMENTAL

Chat bot

Intervention Type: OTHER

Patients in intervention arm will use an evidence-based chat bot as an aid for smoking cessation

Control

Usual care (Madrid Health System Portfolio).

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

Usual care given by their usual general practitioners and nurses of primary care health centres, as defined in Public Health System Portfolio.

Interventions

Chat bot

Patients in intervention arm will use an evidence-based chat bot as an aid for smoking cessation

Intervention Type: OTHER

Usual care

Usual care given by their usual general practitioners and nurses of primary care health centres, as defined in Public Health System Portfolio.

Intervention Type: OTHER

Other Intervention Names

Intervention arm; Active comparator arm

Eligibility Criteria

Inclusion Criteria

• 18 years or more
• Smoked more than one cigarette per day last month.
• Accepts help to quit smoking next month.
• Owns a mobile phone with the ability to install a messaging application.
• Does not anticipate changing address in the next 6 months.
• Understands spoken and written spanish language.
• Accepts to participate and signs the informed consent.

Exclusion Criteria

• Communicative barriers.
• Addiction to other substances.
• Participation in another cessation program or other clinical trial during the study period.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Gerencia de Atención Primaria, Madrid

OTHER_GOV

Sponsor Role: lead

Responsible Party

Eduardo Olano

Phd in Medicine. Family and Community Medicine Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José F Ávila-Tomás, Doctor

Role: STUDY_CHAIR

GAP Madrid

Francisco J Ayesta-Ayesta, Doctor

Role: STUDY_CHAIR

Cantabria University

Francisco J Martínez-Suverbiola, Doctor

Role: STUDY_CHAIR

GAP Madrid

Locations

Eduardo Olano-Espinosa

Alcorcón, Madrid, Spain

Countries

Spain

References

Olano-Espinosa E, Avila-Tomas JF, Minue-Lorenzo C, Matilla-Pardo B, Serrano Serrano ME, Martinez-Suberviola FJ, Gil-Conesa M, Del Cura-Gonzalez I; Dejal@ Group. Effectiveness of a Conversational Chatbot (Dejal@bot) for the Adult Population to Quit Smoking: Pragmatic, Multicenter, Controlled, Randomized Clinical Trial in Primary Care. JMIR Mhealth Uhealth. 2022 Jun 27;10(6):e34273. doi: 10.2196/34273.

Reference Type: DERIVED

PMID: 35759328 (View on PubMed)

Avila-Tomas JF, Olano-Espinosa E, Minue-Lorenzo C, Martinez-Suberbiola FJ, Matilla-Pardo B, Serrano-Serrano ME, Escortell-Mayor E; Group Dej@lo. Effectiveness of a chat-bot for the adult population to quit smoking: protocol of a pragmatic clinical trial in primary care (Dejal@). BMC Med Inform Decis Mak. 2019 Dec 3;19(1):249. doi: 10.1186/s12911-019-0972-z.

Reference Type: DERIVED

PMID: 31796061 (View on PubMed)

Other Identifiers

P17/01942

Identifier Type: -

Identifier Source: org_study_id