So-Lo-Mo Intervention Applied to the Smoking Cessation Process

NCT03553173 | Completed

• 1 other identifier: SFB-APP_EC-2016-01
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized open-label parallel-group trial. 240 subjects will be recruited during 8 months and a 12 months follow-up will be carried out for each one of them. The sample will split in two groups: control group (n=120) who will receive usual psycho-pharmacological therapy and the intervention group (n=120) who will receive usual therapy plus So-Lo-Mo app.

Conditions

Smoking Cessation; Health Behavior; Lifestyle-related Condition

Keywords

Smoking Cessation; App; Decision Support System

Outcome Measures

Primary Outcomes (2)

• Efficacy: Smoking abstinence rate

  Smoking abstinence rate at 1 year measured by means of exhaled Carbon Monoxide (CO) and urinary cotinine tests. Subjects with cotinine concentrations \>200 ng/ml or CO \>6 ppm will be considered as smokers.

  1 year

• Efficiency: Incremental Cost-Effectiveness Ratio

  Expressed in terms of Incremental Cost-Effectiveness Ratio (ICER), calculated by dividing the difference in total costs between the intervention group and the control group by the difference in Quality-Adjusted Life Year (QALY) between both groups. Costs associated to control and intervention groups will include healthcare resources utilization measured in terms of specialist consultations related to the smoking cessation process. Costs of pharmacological treatment and time employed by healthcare professionals during the design phase will also be taken into account. Benefit for patients will be expressed in terms of QALY. EuroQol-5D-5L questionnaire will be used to estimate QALY.

  1 year

Secondary Outcomes (3)

• Incidence of Treatment-Related Adverse Events [Safety]

  1 year

• International Physical Activity Questionnaire (IPAQ27) score [Physical activity]

  From baseline (first evaluation in the study) to 1 year after

• Body Mass Index (BMI) in kg/m^2 [Healthy lifestyle]

  From baseline (first evaluation in the study) to 1 year after

Study Arms (2)

Control

ACTIVE COMPARATOR

Subjects undergoing usual psycho-pharmacological treatment for smoking cessation. Prescribed treatments: * Bupropion pills + Psychological advice * Varenicline pills + Psychological advice

Behavioral: Psychological advice; Drug: Bupropion Pill; Drug: Varenicline Pill

Intervention

EXPERIMENTAL

Subjects undergoing usual psycho-pharmacological treatment for smoking cessation plus a smart phone App. Prescribed treatments: * Bupropion pills + Psychological advice + So-Lo-Mo * Varenicline pills + Psychological advice + So-Lo-Mo

Other: So-Lo-Mo; Behavioral: Psychological advice; Drug: Bupropion Pill; Drug: Varenicline Pill

Interventions

So-Lo-Mo OTHER

So-Lo-Mo is an innovative intervention based on mobile technologies and its capacity to trigger behavioral changes. In this sense, the App is a complement to pharmacological therapies to quit smoking providing personalised motivational messages, physical activity monitoring, lifestyle advices and distractions (mini-games) to help pass the cravings. The main objective of this App is to improve patient's adherence to the smoking cessation process making use of behavioral techniques in the form of motivational messages and/or Short Message Service (SMS).

Also known as: SoLoMo

Intervention

Psychological advice BEHAVIORAL

Provision of information about smoking and smoking cessation process, as well as supporting behavioral changes through the provision of new skills and strategies. The most used methods are the motivational interview and the cognitive-behavioral therapy

Also known as: Behavioral

Control; Intervention

Bupropion Pill DRUG

Formulated as a 150 mg long discharge pill, usually being prescribed a daily dose of 300 mg, except for week one which would be prescribed 150 mg per day. The usual length of the treatment ranges from 7 to 9 weeks. However, 12 weeks treatments could be prescribed for severe cases of smokers.

Also known as: Bupropion

Control; Intervention

Varenicline Pill DRUG

Formulated as 0,5 mg and 1 mg pills, and the dose should be progressively incremented during the first days in order to facilitate tolerance. The recommended length of the treatment is 12 weeks, although longer treatments could be necessary for severe smokers.

Also known as: Varenicline

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smoking population attending to the Smoking Cessation Unit of "Virgen del Rocío" University Hospital.
• Subjects \>18 years old who want to give up smoking.
• Android-based smart phone availability.
• Ability to interact with the smart phone.
• To sign an Informed Consent Form.

You may not qualify if:

• Subjects had some previous adverse effects related to the pharmacological treatment included in the study

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• European Commission: collaborator
• Andaluz Health Service: collaborator

Related Publications (3)

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

  PMID: 34611902 DERIVED

• Carrasco-Hernandez L, Jodar-Sanchez F, Nunez-Benjumea F, Moreno Conde J, Mesa Gonzalez M, Civit-Balcells A, Hors-Fraile S, Parra-Calderon CL, Bamidis PD, Ortega-Ruiz F. A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 27;8(4):e17530. doi: 10.2196/17530.

  PMID: 32338624 DERIVED

• Jodar-Sanchez F, Carrasco Hernandez L, Nunez-Benjumea FJ, Mesa Gonzalez MA, Moreno Conde J, Parra Calderon CL, Fernandez-Luque L, Hors-Fraile S, Civit A, Bamidis P, Ortega-Ruiz F. Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Dec 6;7(12):e12464. doi: 10.2196/12464.

  PMID: 30522992 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Health Behavior; Mental Disorders; Alzheimer Disease

Interventions

Bupropion; Varenicline

Condition Hierarchy (Ancestors)

Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Francisco Ortega-Ruiz, MD, PhD

  Virgen del Rocío University Hiospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized open-label parallel-group trial.

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: June 12, 2018
• Study Start: October 24, 2016
• Primary Completion: October 24, 2018
• Study Completion: October 24, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-12