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

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ClinicalTrials.gov Identifier: NCT03445507
Recruitment Status : Not yet recruiting
First Posted : February 26, 2018
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Eduardo Olano, Gerencia de Atención Primaria, Madrid

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.


Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Other: Chat bot Other: Usual care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care.
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Active comparator arm




Primary Outcome Measures :
  1. Continuous tobacco abstinence at six months biochemically validated [ Time Frame: Six months ]
    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


Secondary Outcome Measures :
  1. Continuous tobacco abstinence at six months referred by patient [ Time Frame: Six months ]
    Patient declares to have smoked less than five cigarettes in the last six months

  2. Descriptive improvement in patient´s quality of life [ Time Frame: Six months ]
    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.

  3. Sujective improvement in patient´s quality of life [ Time Frame: Six months ]

    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.


  4. QALYs [ Time Frame: Six months ]
    Quality-adjusted life years

  5. Number of therapeutic contacts [ Time Frame: Six months ]
    Number of contacts (therapist-patient or bot-patient) during the therapeutic process

  6. Time spent in therapy [ Time Frame: Six months ]
    Total amount of time spent (in minutes) during the therapeutic process



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445507


Contacts
Contact: Eduardo Olano-Espinosa, Doctor (034) 679325778 Eduardo.Olano@salud.madrid.org
Contact: César Minué-Lorenzo, Doctor cesaraugusto.minue@salud.madrid.org

Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
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

Responsible Party: Eduardo Olano, Phd in Medicine. Family and Community Medicine Specialist, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT03445507     History of Changes
Other Study ID Numbers: P17/01942
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eduardo Olano, Gerencia de Atención Primaria, Madrid:
tobacco
cessation
medical apps for smartphones