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

NCT03445507 | Completed

• 1 other identifier: P17/01942
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation

Keywords

tobacco; cessation; medical apps for smartphones

Outcome Measures

Primary Outcomes (1)

• Continuous tobacco abstinence at six months biochemically validated

  Patient declares to have smoked less than five cigarettes in the last six months and have less than 10 parts per million (ppm) of carbon monoxide in exhaled air measured by a Pico+TM Smokerlyzer® cooximeter

  Six months

Secondary Outcomes (6)

• Continuous tobacco abstinence at six months referred by patient

  Six months

• Descriptive improvement in patient´s quality of life

  Six months

• Sujective improvement in patient´s quality of life

  Six months

• QALYs

  Six months

• Number of therapeutic contacts

  Six months

Study Arms (2)

Intervention

EXPERIMENTAL

Use of an evidence-based chat bot for smoking cessation

Other: Chat bot

Control

ACTIVE COMPARATOR

Usual care (Madrid Health System Portfolio).

Other: Usual care

Interventions

Chat bot OTHER

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

Also known as: Intervention arm

Intervention

Usual care OTHER

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

Also known as: Active comparator arm

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Eduardo Olano-Espinosa

Alcorcón, Madrid, 28924, Spain

Location

Related Publications (2)

• 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.

  PMID: 35759328 DERIVED

• 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.

  PMID: 31796061 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• José F Ávila-Tomás, Doctor

  GAP Madrid

  STUDY CHAIR

• Francisco J Ayesta-Ayesta, Doctor

  Cantabria University

  STUDY CHAIR

• Francisco J Martínez-Suverbiola, Doctor

  GAP Madrid

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Intervention can´t be masked. We will objectify primary outcome by biochemistry validation, and statistician conducting the analysis will not know to which study arm a given patient has been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd in Medicine. Family and Community Medicine Specialist

Model Details: N = 460 smokers (230 in each arm), who will be recruited before randomization. Interventions: Intervention group: Use of an evidence-based chat bot for smoking cessation. Control group: Usual care (Madrid Health System Portfolio).

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 26, 2018
• Study Start: October 7, 2018
• Primary Completion: November 7, 2019
• Study Completion: December 31, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

ES (1)