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Tobacco Use CessationDej@loNCT03445507

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

A study testing Chat bot in people with Tobacco Use Cessation, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tobacco Use Cessation
What is being tested?
Chat bot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
542 participants
Where
1 siteSpain
Study dates
7 Oct 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Eduardo Olano-Espinosa

    Alcorcón, Madrid, 28924

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Chat bot, Usual care
Keywords
tobacco, cessation, medical apps for smartphones
Medical subject headings
Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chat botOther

    Also called Intervention arm

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

  • Usual careOther

    Also called Active comparator arm

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

Study groups in NCT03445507
Study groupRoleWhat they receive
InterventionExperimentalUse of an evidence-based chat bot for smoking cessation
Receives: Other: Chat bot
ControlActive comparatorUsual care (Madrid Health System Portfolio).
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Six months

Secondary outcomes (6)

  1. Continuous tobacco abstinence at six months referred by patient

    Patient declares to have smoked less than five cigarettes in the last six months

    Measured: Six months

  2. 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.

    Measured: Six months

  3. 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.

    Measured: Six months

  4. QALYs

    Quality-adjusted life years

    Measured: Six months

  5. Number of therapeutic contacts

    Number of contacts (therapist-patient or bot-patient) during the therapeutic process

    Measured: Six months

  6. Time spent in therapy

    Total amount of time spent (in minutes) during the therapeutic process

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2018
  2. Study start7 Oct 2018
  3. Primary completion7 Nov 2019
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
542 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03445507
Sponsor's protocol ID
P17/01942
Acronym
Dej@lo
Status last verified
Feb 2021
First submitted
6 Feb 2018
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: No Plan has been developed

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.

    PubMed 35759328

  • 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.

    PubMed 31796061

Questions about this trial

What is this clinical trial studying?

A study testing Chat bot in people with Tobacco Use Cessation, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Continuous tobacco abstinence at six months biochemically validated (time frame: Six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03445507, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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