Kondylakis Haridimos, Giglioli Irene Alice Chicchi, Katehakis Dimitrios, Aldemir Hatice, Zikas Paul, Papagiannakis George, Hors-Fraile Santiago, González-Sanz Pedro L, Apostolakis Konstantinos, Stephanidis Constantine, Núñez-Benjumea Francisco J, Baños-Rivera Rosa M, Fernandez-Luque Luis, Kouroubali Angelina
FORTH-ICS, Heraklion, Greece.
Adhera Health Inc, Santa Cruz, CA, United States.
J Med Internet Res. 2025 Jan 7;27:e54049. doi: 10.2196/54049.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT05184725; https://clinicaltrials.gov/study/NCT05184725.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/38536.
接受手术的患者常经历压力和焦虑，这会增加并发症并阻碍康复。有效管理这些心理因素是改善治疗效果的关键。术前焦虑与患者获得的信息量呈负相关，但可获取的个性化支持仍然有限，尤其是在术前阶段。由于资源限制，面对面教育往往不切实际。数字健康（DH）干预提供了一个有前景的替代方案，可增强患者参与度和自主权。然而，当前大多数工具侧重于提供信息，忽视了个性化和心理支持的重要性。
本研究旨在评估一种名为Adhera CARINAE DH计划的数字健康干预措施的可行性。该计划专门设计用于提供基于证据的个性化压力和焦虑管理技术。它通过使用一个综合数字生态系统来实现这一目标，该生态系统包括可穿戴设备、移动应用程序和虚拟现实技术。干预计划还利用先进的数据驱动技术提供量身定制的患者教育和生活方式支持。
2021年9月至2022年3月，来自欧洲3个国家4家医院的74名计划接受手术的患者参与了本研究。手术包括心肺和冠状动脉搭桥手术、心脏瓣膜置换术、前列腺或膀胱癌手术、髋关节和膝关节置换术、颌面外科手术和脊柱侧弯手术。在评估资格后，参与者被随机分为2组：干预组（n = 23）除接受标准护理外，还接受Adhera CARINAE DH干预，而对照组（n = 27）仅接受标准护理。在干预前后评估自我效能感、自我管理和心理健康等心理指标，以及压力的生理指标。
干预组在多个心理结果方面有显著改善。例如，入院时视觉模拟评分压力改善了5%，出院时改善了11.1%，入院时视觉模拟评分疼痛改善了31.2%。此外，术后医院焦虑抑郁量表焦虑改善了15.6%，入院时正负情绪量表消极情绪改善了17.5%。总体而言，干预研究中的患者住院天数减少了17.12%。除了这些个体得分外，干预组在自我效能感、自我管理和心理健康的心理维度之间表现出更积极的关系，这表明CARINAE解决方案可能对减轻压力和负面情绪有积极影响。
我们的结果为更深入理解优化数字健康解决方案以支持接受手术的患者以及在远程患者监测和通信中的潜在应用迈出了重要的第一步。
ClinicalTrials.gov NCT05184725；https://clinicaltrials.gov/study/NCT05184725。
国际注册报告识别码（IRRID）：RR2-10.2196/38536。
