Piloting the SOLOMO App to perform a psychological intervention against smoking, in the context of SmokeFreeBrain project

Smoking is an addictive, chronic and relapsing disease. This is the main cause of preventable death in the occidental world and responsible to multiples diseases. However, this is a disease that we can treat and cure. Currently, there are some tools available to help smokers to stop smoking e.g psychological therapy and new methods like the use of mobile Apps. Virgen del Rocío University Hospital takes part SmokeFreeBrain which aims to develop an intervention based on the use of mobile Apps.

Recent research on the beneficial effect that physical exercise and the feedback through Social Networks from people that successfully completed the smoking cessation process has on people who is currently undergoing this process has shown its usefulness with a moderate level of evidence. Therefore, an intervention based on adherence to physical activity with ICT support (App Gamification, Facebook and SMS) may provide a valuable aid in smoking cessation.

- Primary objective: To analyze the efficacy and efficiency of the SoLoMo intervention applied to the smoking cessation process compared to usual care.
- Secondary objectives: Monitor usual care (behavioural, bupropion and varenicline therapies); Monitor lifestyle and physical exercise habits.

Purpose, target audience, benefits

Study design: 12-months randomized open-label parallel-group trial to determine the impact of this intervention in smoking population attends to the Smoking Cessation Unit of the Virgen del Rocío University Hospital.
We aim to include 120 patients in the intervention group (SoLoMo intervention: pharmacological therapy, psychological therapy and App) and 120 patients in the control group (pharmacological therapy and psychological therapy).

Patients have to be older than 18-years-old, be smokers that want to stop smoking, have a smartphone available, and they don’t have any contraindications related to the offered pharmacological therapy.

Patients recruited in this trial will have the following benefits:
- Closed follow-up in the Smoking Cessation Unit consultation.
- Pharmacological therapy funding.
- Homecare support related to the assistance in the use of the App (only for the intervention group).
- Benefits related to the smoking cessation, like the improvement of the sense of smell, palate, decreased heart rate and hypertension, etc.

Current results
Currently, SoLoMo intervention has recruited 124 patients; among them 24 patients has been drop-out. Main drop-out causes have been side effect related to the pharmacological treatment, loss in the follow-up, and voluntary drop-out of the treatment. 100 patients continue in the trial, among them 51 patients have been included in the control group (pharmacological therapy and psychological therapy) and 49 patients have been included in intervention group (pharmacological therapy, psychological therapy and App). The follow-up stages completed by the recruited patients follow the next distribution:
- 1st consultation (screening): 27 patients.
- 2nd consultation (15 days ± 5): 11 patients.
- 3rd consultation (30 days ± 5): 14 patients.
- 4th consultation (60 days ± 5): 22 patients.
- 5th consultation (90 days ± 5): 12 patients.
- 6th consultation (120 days ± 5): 14 patients.
- 7th consultation (180 days ± 5): 0 patients.
- 8th consultation (365 days ± 5): 0 patients.

The project “SmokeFreeBrain: Multidisciplinary tools for improving the efficacy of public prevention measures against smoking” has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 681130.

Source: http://cordis.europa.eu/news/rcn/141075_en.html?isPermaLink=true?WT.mc_i...