Smoking CessationNCT03206619
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
An observational study of Smoking Cessation and Health Behavior, run by University of Seville at 1 site in Spain.
Trial summary
Patients attending the smoking cessation programme at the Virgen del Rocío University Hospital under the SoLoMo clinical trial of the SmokeFreeBrain project and provided with the SoLoMo mobile app will be observed for one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Health Behavior, Smoking, Tobacco
- What is being tested?
- Social, Local and Mobile
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to 31 Oct 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult smokers living in Seville (Spain)
Who may be able to join
- Patients must be taken from the the smoking cessation unit of the Virgen del Rocio University Hospital (Seville, Spain)
- Patients must be willing to start the treatment to quit smoking
- Patients must own an Android smartphone and be able to interact with it
- Patients must be willing to and install the "Libre de Humos" smoking cessation app recommended by the doctor in the SmokeFreeBrain study.
- Patients must sign an informed consent
Who cannot join
- Patients have known previous adverse effects on the pharmacological treatment included in the study (Bupropion \& Varenicline)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Patient Acceptance and Engagement of Timely Tailored Motivational Messages Sent by a Health Recommender System and Delivered Via a Mobile App for Smoking Cessation
Patients attending the smoking cessation programme at the Virgen del Rocío University Hospital under the SoLoMo clinical trial of the SmokeFreeBrain project and provided with the SoLoMo mobile app will be observed for one year. This mobile app which sends the patients tailored health motivational messages selected by a health recommender system, and based on their user profile retrieved from an electronic health record. Patients' messages feedback and interactions with the app will be analyzed and evaluated following an observational prospective methodology to see whether patients like the messages, and measure the patient engagement with the health recommender system.
- Conditions
- Smoking Cessation, Health Behavior, Smoking, Tobacco, Smoking
- Being tested
- Social, Local and Mobile
- Keywords
- smoking, habit, preference, behavior, tailoring, cessation, engagement, digital, mobile app, recommender system
- Medical subject headings
- Smoking Cessation, Health Behavior, Tobacco Smoking, Smoking, Habits, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social, Local and MobileOther
Also called SoLoMo
Patients in a smoking cessation program will use a mobile application to receive messages and rate them from their smartphones. The messages patient will receive belong to one of the following five topics: general motivation, diet tips, physical exercise tips, personal performance, and the benefits of being a non-smoker. For each one of these topics, there will be a pool of 150 different messages with tailored information for the patient. Topics and messages were approved by a smoking cessation psychologist and a pulmonologist. The selection of the time the messages have to be sent, and the message topic is selected by an health recommender system algorithm based on the patients' user profile (demographic information, message rating information, and app interaction information).
| Study group | Role | What they receive |
|---|---|---|
| Social, Local and Mobile | Patients having smoking cessation standard care (behavioral and pharmacological therapy) and using the SoLoMo mobile app that sends them motivational messages. Receives: Other: Social, Local and Mobile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective quality of the health recommender system
The objective quality of the health recommender system is calculated by measuring its precision. The precision of the health recommender system is the relation between the number of messages patients have rated with positive and/or positive and neutral feedback the first month (baseline), and all subsequent months.
Measured: Up to 18 months
Subjective quality of the health recommender system
The subjective quality of the health recommender systems is determined by eighteen questions which will be answered using a 1 to 5 point Likert scale by all patients finishing their smoking cessation programme.
Measured: Up to 18 months
Engagement at aggregated level - Mobile application rolling retention
The percentage of users still active N days after installation. This is a ratio of the number of users whose last day of activity is past day N to the number of users who could have been active on day N. This metric will be assessed throughout the observation until its end.
Measured: Up to 18 months
Engagement at aggregated level - Mobile application session length distribution
The session length is defined as the length of time between the start of the application event and the end of the application event. The session length determines the engagement as it is relevant to know how much time patients spend in the app per session. This metric will be assessed throughout the observation until its end.
Measured: Up to 18 months
Engagement at aggregated level - Mobile application usage frequency
The frequency of use is a measure of how often each unique patient used the app within a given time interval. This metric will be assessed throughout the observation until its end.
Measured: Up to 18 months
Engagement at aggregated level - Number of sessions per user
A session is one use of the mobile application by a patient. This begins when the application is launched and ends when the application is terminated. This metric will be assessed throughout the observation
until its end.
Measured: Up to 18 months
Engagement at aggregated level - Return rate
Return rate measures the percentage of patients who return to the app on a specific time after installation. It is measured by cohort group - that is, based on when patients first opened the app. It is calculated as the ratio of the number of users active on a given period to the size of the cohort. This metric will be assessed throughout the observation until its end.
Measured: Up to 18 months
Engagement at individual level
Engagement at individual level will be assessed based on the rate of read messages by the patients. This is calculated as the quotient between the messages the patients have read, and the total number of messages the system has sent to the patients. This metric will be assessed throughout the observation until its end.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startSep 2016
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Salumedia Tecnologías, Aristotle University Of Thessaloniki, Northern Greece Neurofeedback Center
- Responsible party
- Principal investigator, Santiago Hors-Fraile, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206619
- Sponsor's protocol ID
- H2020-681120
- Status last verified
- Jun 2019
- First submitted
- 7 Feb 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymized subset of the database will be made available 5 years after the completion of the project. This embargo period aims to support a correct IPR management within the SmokeFreeBrain consortium, as well as to guarantee the availability of the dataset to the SmokeFreeBrain researchers in order to leverage the scientific production related to the project outcomes. The database can be shared at the end of the embargo period but specific consent will be required. The informed consent form and the information sheet provided to the participants will inform them regarding this attribute of the data.
Publications
Hors-Fraile S, Schneider F, Fernandez-Luque L, Luna-Perejon F, Civit A, Spachos D, Bamidis P, de Vries H. Tailoring motivational health messages for smoking cessation using an mHealth recommender system integrated with an electronic health record: a study protocol. BMC Public Health. 2018 Jun 5;18(1):698. doi: 10.1186/s12889-018-5612-5.
PubMed 29871595
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Patient Acceptance and Engagement of Timely Tailored Motivational Messages Sent by a Health Recommender System and Delivered Via a Mobile App for Smoking Cessation
- ClinicalTrials.gov ID
- NCT03206619
- Acronym / sponsor ID
- H2020-681120
- Conditions
- Smoking Cessation, Health Behavior, Smoking, Tobacco, Smoking
- Keywords
- smoking, habit, preference, behavior, tailoring, cessation, engagement, digital
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Salumedia Tecnologías, Aristotle University Of Thessaloniki, Northern Greece Neurofeedback Center
- Study start
- Sep 2016 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients attending the smoking cessation programme at the Virgen del Rocío University Hospital under the SoLoMo clinical trial of the SmokeFreeBrain project and provided with the SoLoMo mobile app will be observed for one year. This mobile app which sends the patients tailored health motivational messages selected by a health recommender system, and based on their user profile retrieved from an electronic health record. Patients' messages feedback and interactions with the app will be analyzed and evaluated following an observational prospective methodology to see whether patients like the messages, and measure the patient engagement with the health recommender system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social, Local and Mobile | – | Other: Social, Local and MobilePatients having smoking cessation standard care (behavioral and pharmacological therapy) and using the SoLoMo mobile app that sends them motivational messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult smokers living in Seville (Spain)
Key inclusion criteria (5 listed)
- Patients must be taken from the the smoking cessation unit of the Virgen del Rocio University Hospital (Seville, Spain)
- Patients must be willing to start the treatment to quit smoking
- Patients must own an Android smartphone and be able to interact with it
- Patients must be willing to and install the "Libre de Humos" smoking cessation app recommended by the doctor in the SmokeFreeBrain study.
- Patients must sign an informed consent
Key exclusion criteria (1 listed)
- Patients have known previous adverse effects on the pharmacological treatment included in the study (Bupropion \& Varenicline)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social, Local and MobileAlso: SoLoMoPatients in a smoking cessation program will use a mobile application to receive messages and rate them from their smartphones. The messages patient will receive belong to one of the following five topics: general motivation, diet tips, physical exercise tips, personal performance, and the benefits of being a non-smoker. For each one of these topics, there will be a pool of 150 different messages with tailored information for the patient. Topics and messages were approved by a smoking cessation psychologist and a pulmonologist. The selection of the time the messages have to be sent, and the message topic is selected by an health recommender system algorithm based on the patients' user profile (demographic information, message rating information, and app interaction information). | Other | Social, Local and Mobile |
Primary outcome
Objective quality of the health recommender system
Time frame: Up to 18 months
The objective quality of the health recommender system is calculated by measuring its precision. The precision of the health recommender system is the relation between the number of messages patients have rated with positive and/or positive and neutral feedback the first month (baseline), and all subsequent months.
Subjective quality of the health recommender system
Time frame: Up to 18 months
The subjective quality of the health recommender systems is determined by eighteen questions which will be answered using a 1 to 5 point Likert scale by all patients finishing their smoking cessation programme.
Engagement at aggregated level - Mobile application rolling retention
Time frame: Up to 18 months
The percentage of users still active N days after installation. This is a ratio of the number of users whose last day of activity is past day N to the number of users who could have been active on day N. This metric will be assessed throughout the observation until its end.
Engagement at aggregated level - Mobile application session length distribution
Time frame: Up to 18 months
The session length is defined as the length of time between the start of the application event and the end of the application event. The session length determines the engagement as it is relevant to know how much time patients spend in the app per session. This metric will be assessed throughout the observation until its end.
Engagement at aggregated level - Mobile application usage frequency
Time frame: Up to 18 months
The frequency of use is a measure of how often each unique patient used the app within a given time interval. This metric will be assessed throughout the observation until its end.
Engagement at aggregated level - Number of sessions per user
Time frame: Up to 18 months
A session is one use of the mobile application by a patient. This begins when the application is launched and ends when the application is terminated. This metric will be assessed throughout the observation until its end.
Engagement at aggregated level - Return rate
Time frame: Up to 18 months
Return rate measures the percentage of patients who return to the app on a specific time after installation. It is measured by cohort group - that is, based on when patients first opened the app. It is calculated as the ratio of the number of users active on a given period to the size of the cohort. This metric will be assessed throughout the observation until its end.
Engagement at individual level
Time frame: Up to 18 months
Engagement at individual level will be assessed based on the rate of read messages by the patients. This is calculated as the quotient between the messages the patients have read, and the total number of messages the system has sent to the patients. This metric will be assessed throughout the observation until its end.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Derived from this study: PubMed 29871595Hors-Fraile S, Schneider F, Fernandez-Luque L, Luna-Perejon F, Civit A, Spachos D, Bamidis P, de Vries H. Tailoring motivational health messages for smoking cessation using an mHealth recommender system integrated with an electronic health record: a study protocol. BMC Public Health. 2018 Jun 5;18(1):698. doi: 10.1186/s12889-018-5612-5.
- Official website of the original projectLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. An anonymized subset of the database will be made available 5 years after the completion of the project. This embargo period aims to support a correct IPR management within the SmokeFreeBrain consortium, as well as to guarantee the availability of the dataset to the SmokeFreeBrain researchers in order to leverage the scientific production related to the project outcomes. The database can be shared at the end of the embargo period but specific consent will be required. The informed consent form and the information sheet provided to the participants will inform them regarding this attribute of the data.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Health Behavior, run by University of Seville 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 5 inclusion and 1 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 25 Jun 2019. 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?
Objective quality of the health recommender system (time frame: Up to 18 months). The study lists 8 primary outcomes in all. 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 NCT03206619, which also lists 1 linked publication.
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 25 Jun 2019.