NCT05184725

CARINAE for Stress Relief in Perioperative Care

CARINAE: A Digital Health Intervention for Stress Relief in Perioperative Care: Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Adhera Health, Inc. · Industry
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure. Provision of education and information about the surgery can be a crucial component of the preoperative experience and is inversely related to levels of preoperative anxiety. However, resource constraints make face-to-face education sessions untenable, given cost considerations and time investment by trained health personnel. Interventions based on mobile health (mHealth) technologies, geared towards increasing familiarity with surgical procedures and hospital environments have been shown to help patients feel informed about possible benefits and risks of available treatment options. mHealth apps and Virtual Reality (VR) can offer patients experience in the perioperative environment that can be helpful in empowering patients and enhancing a more positive experience, while reducing stress. However, available applications focus only on providing informative content, neglecting the importance of patient empowerment with a more robust educational curriculum. According to this, the Software as a Medical Device (SaMD) CARINAE, aims to support patients and caregivers during the whole perioperative process. SaMD CARINAE consists of an mHealth mobile application for patients and caregivers, a Virtual Reality headset for patients, and a web application for healthcare professionals.

Detailed description

Patients will be randomly assigned to intervention group or the control group. Intervention group will be exposed to the use of SaMD CARINAE for 2 months approximately. The intervention trial will include a total of 4 visits: 1. Recruitment; 2. Hospital admission; 3. Hospital discharge; 4. Post-operative follow-up in 14 days. SaMD CARINAE delivers the following interventions to the patients: * Personalised patient-centred health education program to improve patient's condition and recovery self-management skills. * Artificial Intelligence-based behaviour change program to promote healthier lifestyle habits. * Personalised mental well-being coaching program to improve patient's ability to cope with emotional disturbances such as stress and anxiety. * A collaborative digital support platform to enable information exchange between patients, caregivers, and healthcare professionals. The program is delivered to patients and caregivers as a SaMD mHealth application (smartphone app) and an immersive environment with a VR device. Healthcare professionals will be able to access the collaborative digital support platform through a web application. Finally, the control group will not be exposed to SaMD CARINAE solution, following the traditional routine visits, and after each traditional visit patients will answer to questionnaires specified in the secondary outcome measures section.

Conditions

• Psychological Stress
• Cardiopulmonary Bypass Surgery
• Coronary Artery Bypass Surgery
• Cardiac Valve Replacement
• Hip Replacement
• Orthognathic Surgery
• Scoliosis
• Knee Replacement
• Prostate Cancer
• Kidney Cancer
• Bladder Cancer

Interventions

Type	Name	Description
DEVICE	SaMD CARINAE	SaMD CARINAE delivers the following digital therapeutic intervention to the patients: 1) Personalised patient-centred health education program to improve patient's disease and recovery self-management skills. 2) AI-based behaviour change program to promote healthier lifestyle habits. 3) Personalised mental well-being coaching program to improve patient's ability to cope with emotional disturbances such as stress and anxiety. 4) A collaborative digital support platform to enable information exchange between patients, caregivers, and healthcare professionals.

Timeline

• Start date: 2022-01-10
• Primary completion: 2022-04-30
• Completion: 2022-05-31
• First posted: 2022-01-11
• Last updated: 2022-08-01

Locations

5 sites across 3 countries: Italy, Netherlands, Spain