A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme

June 22, 2019 updated by: Santiago Hors-Fraile, University of Seville

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Seville, Spain, 41013
        • Virgen del Rocio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult smokers living in Seville (Spain)

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients have known previous adverse effects on the pharmacological treatment included in the study (Bupropion & Varenicline)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Social, Local and Mobile
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).
Other Names:
  • SoLoMo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 18 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.
Up to 18 months
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.
Up to 18 months
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.
Up to 18 months
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.
Up to 18 months
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.
Up to 18 months
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.
Up to 18 months
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.
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Seville

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aristotle University Of Thessaloniki
Hospitales Universitarios Virgen del Rocío
Salumedia Tecnologias
Northern Greece Neurofeedback Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H2020-681120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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