CARINAE for Stress Relief in Perioperative Care

Adhera Health

Status: Completed

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

Treatments: Device: SaMD CARINAE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05184725

CAR-0320

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients planned for one of the selected surgery types:
• Cardiopulmonary bypass (CPB) surgery (Maastricht UMC+)
• Coronary artery bypass surgery (Maastricht UMC+)
• Cardiac valve replacement (SAS, Maastricht UMC+)
• Prostate, kidney, and bladder cancer surgery (INRCA)
• Hip and knee replacement (HSJD; Parc Tauli)
• Maxillofacial surgery (HSJD)
• Orthognathic surgery (HSJD)
• Scoliosis (HSJD)
• Signed informed consent (by patient or legal guardian in paediatric cases).
• Patients ≥ 18 years old, except for paediatric Hospital San Joan de Deu (HSJD) ≥ 8 years old.
• Patient owns a smartphone with Android version 4.4 or above.
• Patient (or legal guardian/caregiver in paediatric cases) is able to demonstrate basic digital literacy (e.g. knows how to communicate through instant messaging apps or similar).

Exclusion criteria

• Dementia.
• Pregnant women.
• Inability to understand the local language.
• Allergic to dedicated wearable material (stainless steel and silicone).
• Currently enrolled in a different clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control Group

No Intervention group

Description:

Patients will follow the usual care procedures and after each procedure they answer questionnaires related to pain and stress levels (VAS), Anxiety and depression levels (HADS), health-related quality of life (HRQoL), mental wellbeing (SWEMWBS), self-efficacy (GSE) and Patient Activation status (PAM-13).

SaMD CARINAE

Experimental group

Description:

Intervention group will be exposed to the use of SaMD CARINAE for 2 months approximately, a patientcentred digital health support program. The intervention trial will include a total of 4 visits: 1. Baseline (2-4 weeks before surgery); 2. Hospital admission (1-3 days before surgery); 3. Hospital discharge (1 week after the surgery approx.); 4. Post-operative day 14 (2 weeks after the surgery approx). After each visit and intervention trial with SaMD CARINAE the experimental group answer the same questionnaires of the control group, above mentioned Participants allocated to the intervention group will also be asked to complete questionnaires about usability, satisfaction and subjective experience.

Treatment:

Device: SaMD CARINAE