CARINAE for Stress Relief in Perioperative Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Device: SaMD CARINAE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The SaMD CARINAE embeds the I-Change Model, which claims that behavioral changes depend on the inner motivation to perform a specific behavior and the self-perception of personal abilities, or self-efficacy perception, to carry out the behavioral change.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>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). | |
| Experimental: SaMD CARINAE<br>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. | Device: SaMD CARINAE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for Stress | Patient and caregiver-reported visual analog scale question to assess subjective stress. Along a 100 mm horizontal line, patient and caregiver indicate their perceived stress intensity. Rating varies from 0 (minimum values) to 100 (maximum value). Ratings of 0 to 4 mm can be considered no stress; 5 to 44 mm, mild stress; 45 to 74 mm, moderate stress; and 75 to 100 mm, severe stress. | 2 months: from baseline to 14 days after the surgery | 
| Visual Analog Scale for Pain | Patient-reported visual analog scale question to assess subjective pain. Along a 100 mm horizontal line, patient and caregiver indicate their perceived pain intensity. Rating varies from 0 (minimum values) to 100 (maximum value). Ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. | 2 months: from baseline to 14 days after the surgery | 
| Hospital Anxiety and Depression Scale | Patient-reported questionnaire on anxiety and depression levels during the hospital stay. Hospital Anxiety and Depression Scale is a fourteen-item scale with seven items each for anxiety and depression subscales evaluated on a 0-3 Likert Scale. Rating varies from 0 to 21 and a subscale score >8 denotes anxiety or depression. | 45 days: From hospital admission to 14 days after the surgery | 
| Health-related Quality of Life - EQ-5D-3L/-Y | Patient-reported questionnaire on quality of life. The questionnaire consists of five items related each to one dimension: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status. | 45 days: From hospital admission to 14 days after the surgery | 
| The Positive and Negative Affect Schedule | Patient-reported questionnaire on emotional status. It consists of 20 items that describe n emotions of a positive or negative nature, 10 of them positive and 10 negative. Each item is answered using an Likert-tscale with 5 response options (not at all, very little, somewhat, quite a lot, very much). Scores can range from 10 - 50, with higher scores representing higher levels of positive or negative affect. | 45 days: From hospital admission to 14 days after the surgery | 
| The Short Warwick-Edinburgh Mental Well-Being Scale | Patient- and caregiver-reported questionnaire on mental well-being. It consists of 7 items and each item is answered using a 1-5 Likert scale. Scores range from 7 to 35 and higher scores indicate higher positive mental wellbeing. | 2 months: from baseline to 14 days after the surgery | 
| General Self-Efficacy Scale | Patient- and caregiver-reported questionnaire on self-efficacy perception. It consists of 10 items evaluated on a 1-4 Likert scale. Scores range from 10 to 40 amd higher scores indicate higher self-efficacy. | 2 months: from baseline to 14 days after the surgery | 
| Patient Activation Measure | Patient-reported questionnaire on the level of activation. It consists of 13 items that have four possible response options ranging from (1) strongly disagree to (4) strongly agree, and an additional not applicable option. To calculate the total score, the raw score is divided by the number of items answered (excepting non-applicable items) and multiplied by 13. Then, this score is transformed to a scale with a theoretical range 0-100, based on calibration tables, with higher scores indicating higher patient activation. The raw scores can be converted into four activation levels: 1 (≤47.0) not believing activation important, 2 (47.1-55.1) a lack of knowledge and confidence to take action, 3 (55.2-67.0) beginning to take action and 4 (≥67.1) taking action. | 45 days: From baseline to hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale | Questionnaire on SaMD CARINAE usability by patients, caregivers and healthcare professionals | 30 days: from hospital admission to 14 days after surgery | 
| Usability questionnaire | Ad-hoc questionnaire for patients and healthcare professional on the digital solution usability | 30 days: from hospital admission to 14 days after surgery | 
| Net Promoter Score | Net Promoter Score (NPS) is a questionnaire that measures patient and healthcare professionals experience and provides the core measurement for customer experience management programs. | 30 days: from hospital admission to 14 days after surgery | 
| Reliability | Ad-Hoc questionnaire for the healthcare professional on the digital solution | Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-operative Stress, mHealth Device, Virtual Reality (VR), Health Recommender System, I-Change Behavioral Change Model, Artificial Intelligence (AI), Software as a Medical Device (SaMD)