Remote Monitoring Telemedicine (REMOTE) Platform for Patients With Anxiety Symptoms and Alcohol Use Disorder: Protocol for a Case-Control Study

• Published in: JMIR research protocols 2020-06, Vol.9 (6), p.e16964-e16964
• Main Authors: Pastor, Núria, Khalilian, Elizabeth, Caballeria, Elsa, Morrison, Danielle, Sanchez Luque, Unai, Matrai, Silvia, Gual, Antoni, López-Pelayo, Hugo
• Format: Article
• Language: English
• Subjects: Protocol
• ISSN: 1929-0748; 1929-0748
• DOI: 10.2196/16964

BACKGROUNDMonitoring mental health outcomes has traditionally been based on heuristic decisions, often based on scarce, subjective evidence, making the clinical decisions made by professionals, as well as the monitoring of these diseases, subject to flaws. However, the digital phenotype, which refers to the analysis of data collected by measuring human behavior with mobile sensors and smart bracelets, is a promising tool for filling this gap in current clinical practice. OBJECTIVEThe objectives of this study are to develop the digital phenotyping of patients with alcohol use disorder and anxiety symptoms using data collected from a mobile device (ie, smartphone) and a wearable sensor (ie, Fitbit) and to analyze usability and patient satisfaction with the data collection service provided by the app. METHODSWe propose to conduct a study among a group of 60 participants split into two subgroups-experimental and control-of 30 participants each. The experimental group will be recruited by physicians from the Hospital Clínic de Barcelona, and the control group will be recruited on a volunteer basis through fliers and social media. All participants will go through pretraining to ensure technological capability and understanding of tasks, then each participant will download the HumanITcare app and will be given a wearable sensor (ie, Fitbit). Throughout the 4-month period, participants will be monitored on a range of factors, including sleep cycle, heart rate, movement patterns, and sociability. All data from the wearable sensors and the mobile devices will be saved and sent to the HumanITcare server. Participants will be asked to complete weekly questionnaires about anxiety, depression, and alcohol use disorder symptoms. Research assistants will ensure timely responses. The data from both sensors will then be compared to the questionnaire responses to determine how accurately the devices can predict the same symptoms. RESULTSThe recruitment phase was completed in November 2019 and all the data were collected by the end of December 2019. Data are being processed; this process is expected to be completed by October 2020. CONCLUSIONSThis study was created and conducted as a pilot study with the Hospital Clínic de Barcelona, with the purpose of exploring the feasibility of our approach. The study is focused on patients diagnosed with anxiety and alcohol use disorder, but participants were also monitored for depressive symptoms throughout the trial, although these wer