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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03206619
Other study ID # H2020-681120
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date October 31, 2018

Study information

Verified date June 2019
Source University of Seville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Spain Virgen del Rocío University Hospital Seville

Sponsors (5)

Lead Sponsor Collaborator
University of Seville Aristotle University Of Thessaloniki, Hospitales Universitarios Virgen del Rocío, Northern Greece Neurofeedback Center, Salumedia Tecnologías

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 18 months
Primary 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. Up to 18 months
Primary 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. Up to 18 months
Primary 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. Up to 18 months
Primary 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. Up to 18 months
Primary 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.
Up to 18 months
Primary 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. Up to 18 months
Primary 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. Up to 18 months
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