An interventional study of Chat bot and Usual care in Tobacco Use Cessation, sponsored by Gerencia de Atención Primaria, Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Gerencia de Atención Primaria, Madrid · Not applicable, Interventional, and Treatment
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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.
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.
276 studies on the registry are indexed under Tobacco Use Cessation; 45 are open to participants now.
This study's enrollment of 542 is above the median of 226 across 256 interventional studies indexed under Tobacco Use Cessation.
Browse Tobacco Use Cessation studies →Gerencia de Atención Primaria, Madrid is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of an evidence-based chat bot for smoking cessation
Other: Chat bot
Usual care (Madrid Health System Portfolio).
Other: Usual care
Patients in intervention arm will use an evidence-based chat bot as an aid for smoking cessation
Also known as: Intervention arm
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
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
Time frame: Six months
Continuous tobacco abstinence at six months referred by patient
Patient declares to have smoked less than five cigarettes in the last six months
Time frame: 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.
Time frame: 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.
Time frame: Six months
QALYs
Quality-adjusted life years
Time frame: Six months
Number of therapeutic contacts
Number of contacts (therapist-patient or bot-patient) during the therapeutic process
Time frame: Six months
Time spent in therapy
Total amount of time spent (in minutes) during the therapeutic process
Time frame: Six months
Plan to share: Undecided — No Plan has been developed
Ran from Oct 2018 to primary completion in Nov 2019, 13 months.
Of 115 non-industry interventional studies with no phase under Tobacco Use Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's 13 months is below that.
Counting every sponsor, half of 116 studies reached it within 24 months; a quarter within 15 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Gerencia de Atención Primaria, Madrid