Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care. (Dej@lo)

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Other: Chat bot; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 542
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28924
      • Eduardo Olano-Espinosa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Use of an evidence-based chat bot for smoking cessation	Other: Chat bot; Patients in intervention arm will use an evidence-based chat bot as an aid for smoking cessation; Other Names: Intervention arm
Active Comparator: Control; Usual care (Madrid Health System Portfolio).	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.; Other Names: Active comparator arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous tobacco abstinence at six months referred by patient	Patient declares to have smoked less than five cigarettes in the last six months	Six months
Descriptive improvement in patient´s quality of life	EuroQol 5D-5L questionary score descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Patient is asked to indicate health state by ticking the box next to the most appropriate statement in each dimension. This results in a 1-digit number that expresses the level selected for that dimension. Digits can be combined into a 5-digit number that describes the patient's health state.	Six months
Sujective improvement in patient´s quality of life	EuroQol 5D-5L questionary score visual analogue scale (EQ VAS). EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. Can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	Six months
QALYs	Quality-adjusted life years	Six months
Number of therapeutic contacts	Number of contacts (therapist-patient or bot-patient) during the therapeutic process	Six months
Time spent in therapy	Total amount of time spent (in minutes) during the therapeutic process	Six months

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid
• Collaborators: Instituto de Salud Carlos III
• Investigators: Study Chair: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2018
• Primary Completion (Actual): November 7, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: tobacco; cessation; medical apps for smartphones
• Other Study ID Numbers: P17/01942

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No Plan has been developed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No