Development, Validation, and Implementation of an Innovative Mobile App for Alcohol Dependence Management: Protocol for the SIDEAL Trial.

Background: Information and communication technologies (ICT) have become one of the main pathways to the new paradigm of increased self-management of chronic conditions such as alcohol dependence. Validation of some mobile phone apps has begun, while validation of many others is forthcoming.

Objective: To describe the protocol for validation of a new app called SIDEAL (an acronym of the Spanish name "Soporte Innovador a la persona con DEpendencia del ALcohol," or innovative support for people with alcohol dependence).

Methods: The project consists of 3 complementary, consecutive studies, including a pilot feasibility study, a qualitative study using focus groups, and, finally, a randomized controlled trial where patients will be randomized to standard treatment or standard treatment plus SIDEAL. During the pilot study, feasibility, usability, and acceptance by users will be the main outcomes explored. An electronic questionnaire will be sent to patients asking for their opinions. Focus groups will be the next step, after which improvements and refinements will be implemented in the app. During the final phase, consumption variables (heavy drinking days per month, mean standard drinks per day) will be investigated, in order to test app efficacy.

Results: Because of the encouraging results with previous similar apps, we expect patients to widely accept and incorporate SIDEAL into their therapeutic options. Significant reductions in drinking-related variables are also expected. The pilot study has concluded with the inclusion of 29 patients. Results are expected to be available soon (expected mid-2016).

Conclusions: SIDEAL may represent a useful, reliable, effective, and efficient tool to complement therapeutic options available to both patients and professionals.