Background: Smoking cessation is a persistent leading public health challenge. Mobile health (mHealth) solutions are emerging to improve smoking cessation treatments. Previous approaches have proposed supporting cessation with tailored motivational messages. Some managed to provide short-term improvements in smoking cessation. Yet, these approaches were either static in terms of personalization or human-based nonscalable solutions. Additionally, long-term effects were neither presented nor assessed in combination with existing psychopharmacological therapies. Objective: This study aimed to analyze the long-term efficacy of a mobile app supporting psychopharmacological therapy for smoking cessation and complementarily assess the involved innovative technology. Methods: A 12-month, randomized, open-label, parallel-group trial comparing smoking cessation rates was performed at Virgen del Rocío University Hospital in Seville (Spain). Smokers were randomly allocated to a control group (CG) receiving usual care (psychopharmacological treatment, n=120) or an intervention group (IG) receiving psychopharmacological treatment and using a mobile app providing artificial intelligence–generated and tailored smoking cessation support messages (n=120). The secondary objectives were to analyze health-related quality of life and monitor healthy lifestyle and physical exercise habits. Safety was assessed according to the presence of adverse events related to the pharmacological therapy. Per-protocol and intention-to-treat analyses were performed. Incomplete data and multinomial regression analyses were performed to assess the variables influencing participant cessation probability. The technical solution was assessed according to the precision of the tailored motivational smoking cessation messages and user engagement. Cessation and no cessation subgroups were compared using t tests. A voluntary satisfaction questionnaire was administered at the end of the intervention to all participants who completed the trial. Results: In the IG, abstinence was 2.75 times higher (adjusted OR 3.45, P=.01) in the per-protocol analysis and 2.15 times higher (adjusted OR 3.13, P=.002) in the intention-to-treat analysis. Lost data analysis and multinomial logistic models showed different patterns in participants who dropped out. Regarding safety, 14 of 120 (11.7%) IG participants and 13 of 120 (10.8%) CG participants had 19 and 23 adverse events, respectively (P=.84). None of the clinical secondary objective measures showed relevant differences between the groups. The system was able to learn and tailor messages for improved effectiveness in supporting smoking cessation but was unable to reduce the time between a message being sent and opened. In either case, there was no relevant difference between the cessation and no cessation subgroups. However, a significant difference was found in system engagement at 6 months (P=.04) but not in all subsequent months. High system appreciation was reported at the end of the study. Conclusions: The proposed mHealth solution complementing psychopharmacological therapy showed greater efficacy for achieving 1-year tobacco abstinence as compared with psychopharmacological therapy alone. It provides a basis for artificial intelligence–based future approaches. Trial Registration: ClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/NCT03553173 International Registered Report Identifier (IRRID): RR2-10.2196/12464

Background: Physical activity (PA) is the most well-established lifestyle factor associated with breast cancer (BC) survival. Even women with advanced BC may benefit from moderate PA. However, most BC symptoms and treatment side effects are barriers to PA. Mobile health coaching systems can implement functionalities and features based on behavioral change theories to promote healthier behaviors. However, to increase its acceptability among women with BC, it is essential that these digital persuasive systems are designed considering their contextual characteristics, needs, and preferences. Objective: This study aimed to examine the potential acceptability and feasibility of a mobile-based intervention to promote PA in patients with BC; assess usability and other aspects of the user experience; and identify key considerations and aspects for future improvements, which may help increase and sustain acceptability and engagement. Methods: A mixed methods case series evaluation of usability and acceptability was conducted in this study. The study comprised 3 sessions: initial, home, and final sessions. Two standardized scales were used: the Satisfaction with Life Scale and the International Physical Activity Questionnaire–Short Form. Participants were asked to use the app at home for approximately 2 weeks. App use and PA data were collected from the app and stored on a secure server during this period. In the final session, the participants filled in 2 app evaluation scales and took part in a short individual interview. They also completed the System Usability Scale and the user version of the Mobile App Rating Scale. Participants were provided with a waist pocket, wired in-ear headphones, and a smartphone. They also received printed instructions. A content analysis of the qualitative data collected in the interviews was conducted iteratively, ensuring that no critical information was overlooked. Results: The International Physical Activity Questionnaire–Short Form found that all participants (n=4) were moderately active; however, half of them did not reach the recommended levels in the guidelines. System Usability Scale scores were all >70 out of 100 (72.5, 77.5, 95, and 80), whereas the overall user version of the Mobile App Rating Scale scores were 4, 4.3, 4.4, and 3.6 out of 5. The app was perceived to be nice, user-friendly, straightforward, and easy to understand. Recognition of achievements, the possibility of checking activity history, and the rescheduling option were positively highlighted. Technical difficulties with system data collection, particularly with the miscount of steps, could make users feel frustrated. The participants suggested improvements and indicated that the app has the potential to work well for survivors of BC. Conclusions: Early results presented in this study point to the potential of this tool concept to provide a friendly and satisfying coaching experience to users, which may help improve PA adherence in survivors of BC.

Mobile Health (mHealth) has a great potential to enhance the self-management of cancer patients and survivors. Our study aimed to perform a scoping review to evaluate the impact and trends of mobile application-based interventions on adherence and their effects on health outcomes among the cancer population. In addition, we aimed to develop a taxonomy of mobile-app-based interventions to assist app developers and healthcare researchers in creating future mHealth cancer care solutions. Relevant articles were screened from the online databases PubMed, EMBASE, and Scopus, spanning the time period from 1 January 2016 to 31 December 2022. Of the 4135 articles initially identified, 55 were finally selected for the review. In the selected studies, breast cancer was the focus of 20 studies (36%), while mixed cancers were the subject of 23 studies (42%). The studies revealed that the usage rate of mHealth was over 80% in 41 of the 55 studies, with factors such as guided supervision, personalized suggestions, theoretical intervention foundations, and wearable technology enhancing adherence and efficacy. However, cancer progression, technical challenges, and unfamiliarity with devices were common factors that led to dropouts. We also proposed a taxonomy based on diverse theoretical foundations of mHealth interventions, delivery methods, psycho-educational programs, and social platforms. We suggest that future research should investigate, improve, and verify this taxonomy classification to enhance the design and efficacy of mHealth interventions.

Mobile health technology holds great promise for the clinical management of patients with chronic disease. However, evidence on the implementation of projects involving digital health solutions in rheumatology is scarce. We aimed to study the feasibility of a hybrid (virtual and face-to-face) monitoring strategy for personalized care in rheumatoid arthritis (RA) and spondyloarthritis (SpA). This project included the development of a remote monitoring model and its assessment. After a focus group with patients and rheumatologists, relevant concerns regarding the management of RA and SpA were raised, leading to the development of the Mixed Attention Model (MAM), which combined hybrid (virtual and face-to-face) monitoring. Then, a prospective study using the mobile solution Adhera for Rheumatology was conducted. Over a 3-month follow-up period, patients were given the opportunity to complete disease-specific electronic patient reported outcomes (ePROs) for RA and SpA with a pre-established frequency, as well as flares and changes in medication at any time. Number of interactions and alerts were assessed. The usability of the mobile solution was measured by the Net-Promoter Score (NPS) and through a 5-star Likert scale. Following the MAM development, forty-six patients were recruited to utilize the mobile solution, of whom 22 had RA and 24 SpA. There were 4,019 total interactions in the RA group, and 3,160 in the SpA group. Fifteen patients generated a total of 26 alerts, of which 24 were flares and 2 were medication-related problems; most (69%) were managed remotely. Regarding patient satisfaction, 65% of the respondents were considered to have endorsed Adhera for Rheumatology, yielding a NPS of 57 and an overall rating was 4.3 out of 5 stars. We concluded that the use of the digital health solution is feasible in clinical practice to monitor ePROs for RA and SpA. Next steps involve the implementation of this telemonitoring method in a multicentric setting.

Background: Patients undergoing surgery often experience stress and anxiety, which can increase complications and hinder recovery. Effective management of these psychological factors is key to improving outcomes. Preoperative anxiety is inversely correlated with the amount of information patients receive, but accessible, personalized support remains limited, especially in preoperative settings. Face-to-face education is often impractical due to resource constraints. Digital health (DH) interventions offer a promising alternative, enhancing patient engagement and empowerment. However, most current tools focus on providing information, overlooking the importance of personalization and psychological support. Objective: This study aimed to assess the viability of a DH intervention known as the Adhera CARINAE DH Program. This program is specifically designed to offer evidence-based and personalized stress- and anxiety-management techniques. It achieves this by using a comprehensive digital ecosystem that incorporates wearable devices, mobile apps, and virtual reality technologies. The intervention program also makes use of advanced data-driven techniques to deliver tailored patient education and lifestyle support. Methods: A total of 74 patients scheduled for surgery across 4 hospitals in 3 European countries were enrolled in this study from September 2021 to March 2022. Surgeries included cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacements, prostate or bladder cancer surgeries, hip and knee replacements, maxillofacial surgery, and scoliosis procedures. After assessment for eligibility, participants were randomized into 2 groups: the intervention group (n=23) received the Adhera CARINAE DH intervention in addition to standard care, while the control group (n=27) received standard care alone. Psychological metrics such as self-efficacy, self-management, and mental well-being were assessed before and after the intervention, alongside physiological markers of stress. Results: The intervention group demonstrated significant improvements across several psychological outcomes. For example, Visual Analogue Scale Stress at the hospital improved at admission by 5% and at hospital discharge by 11.1% and Visual Analogue Scale Pain at admission improved by 31.2%. In addition, Hospital Anxiety and Depression Scale Anxiety after surgery improved by 15.6%, and Positive and Negative Affect Scale-Negative at hospital admission improved by 17.5%. Overall, patients in the intervention study spent 17.12% less days in the hospital. Besides these individual scores, the intervention group shows more positive relationships among the psychological dimensions of self-efficacy, self-management, and mental well-being, suggesting that the CARINAE solution could have a positive effect and impact on the reduction of stress and negative emotions. Conclusions: Our results provide an important first step toward a deeper understanding of optimizing DH solutions to support patients undergoing surgery and for potential applications in remote patient monitoring and communication. Trial Registration: ClinicalTrials.gov NCT05184725; https://clinicaltrials.gov/study/NCT05184725 International Registered Report Identifier (IRRID): RR2-10.2196/38536

Background: Stress and anxiety are psychophysiological responses commonly experienced by patients during the perioperative process that can increase presurgical and postsurgical complications to a comprehensive and positive recovery. Preventing and intervening in stress and anxiety can help patients achieve positive health and well-being outcomes. Similarly, the provision of education about surgery can be a crucial component and is inversely correlated with preoperative anxiety levels. However, few patients receive stress and anxiety relief support before surgery, and resource constraints make face-to-face education sessions untenable. Digital health interventions can be helpful in empowering patients and enhancing a more positive experience. Digital health interventions have been shown to help patients feel informed about the possible benefits and risks of available treatment options. However, they currently focus only on providing informative content, neglecting the importance of personalization and patient empowerment. Objective: This study aimed to explore the feasibility of a digital health intervention called the Adhera CARINAE Digital Health Program, designed to provide evidence-based, personalized stress- and anxiety-management methods enabled by a comprehensive digital ecosystem that incorporates wearable, mobile, and virtual reality technologies. The intervention program includes the use of advanced data-driven techniques for tailored patient education and lifestyle support. Methods: The trial will include 5 hospitals across 3 European countries and will use a randomized controlled design including 30 intervention participants and 30 control group participants. The involved surgeries are cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacement, prostate or bladder cancer surgeries, hip and knee replacement, maxillofacial surgery, or scoliosis. The control group will receive standard care, and the intervention group will additionally be exposed to the digital health intervention program. Results: The recruitment process started in January 2022 and has been completed. The primary impact analysis is currently ongoing. The expected results will be published in early 2023. Conclusions: This manuscript details a comprehensive protocol for a study that will provide valuable information about the intervention program, such as the measurement of comparative intervention effects on stress; anxiety and pain management; and usability by patients, caregivers, and health care professionals. This will contribute to the evidence planning process for the future adoption of diverse digital health solutions in the field of surgery. Trial Registration: ClinicalTrials.gov NCT05184725; https://www.clinicaltrials.gov/ct2/show/NCT05184725 International Registered Report Identifier (IRRID): DERR1-10.2196/38536