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

Tobacco Use Cessation Clinical Trial

— Dej@lo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445507
• Other study ID #: P17/01942
• Status: Completed
• Phase: N/A
• Start date: October 7, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: December 31, 2020
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Other:
• Chat bot
Patients in intervention arm will use an evidence-based chat bot as an aid for smoking cessation
• Usual care
Usual care given by their usual general practitioners and nurses of primary care health centres, as defined in Public Health System Portfolio.

Locations

Country	Name	City	State
Spain	Eduardo Olano-Espinosa	Alcorcón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	QALYs	Quality-adjusted life years	Six months
Secondary	Number of therapeutic contacts	Number of contacts (therapist-patient or bot-patient) during the therapeutic process	Six months
Secondary	Time spent in therapy	Total amount of time spent (in minutes) during the therapeutic process	Six months