Clinical trial NCT05184725: CARINAE for Stress Relief in Perioperative Care
Official title: CARINAE: A Digital Health Intervention for Stress Relief in Perioperative Care: Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: 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)
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Maastricht University Medical Center
name: Hospital Sant Joan de Deu
name: Parc Taulí Hospital Universitari
name: Hospital Universitario Reina Sofia de Cordoba
name: Istituto Nazionale di Ricovero e Cura per Anziani
First posted: 2022-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale for Stress
timeFrame: 2 months: from baseline to 14 days after the surgery
measure: Visual Analog Scale for Pain
timeFrame: 2 months: from baseline to 14 days after the surgery
measure: Hospital Anxiety and Depression Scale
timeFrame: 45 days: From hospital admission to 14 days after the surgery
measure: Health-related Quality of Life - EQ-5D-3L/-Y
timeFrame: 45 days: From hospital admission to 14 days after the surgery
measure: The Positive and Negative Affect Schedule
timeFrame: 45 days: From hospital admission to 14 days after the surgery
measure: The Short Warwick-Edinburgh Mental Well-Being Scale
timeFrame: 2 months: from baseline to 14 days after the surgery
measure: General Self-Efficacy Scale
timeFrame: 2 months: from baseline to 14 days after the surgery
measure: Patient Activation Measure
timeFrame: 45 days: From baseline to hospital discharge
Secondary outcomes:
measure: System Usability Scale
timeFrame: 30 days: from hospital admission to 14 days after surgery
measure: Usability questionnaire
timeFrame: 30 days: from hospital admission to 14 days after surgery
measure: Net Promoter Score
timeFrame: 30 days: from hospital admission to 14 days after surgery
measure: Reliability
timeFrame: Day 60
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Istituto di Ricovero e Cura per Anziani
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
state: Andalucía
city: Esplugues De Llobregat
country: Spain
facility: Hospital San Joan de Deu
state: Catalunya
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Catalunya
Study officials:
affiliation: Hospital San Joan de Deu
name: Clara Hernández Cera
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Reina Sofía
name: Ignacio Muñoz Carvajal
role: STUDY_DIRECTOR
affiliation: Hospital San Joan de Deu
name: Juan José Lázaro Alcay
role: STUDY_CHAIR
affiliation: Parc Taulí Hospital Universitari
name: Andrea Vallejo Tarrat
role: STUDY_CHAIR
affiliation: Maastricht University Medical Center
name: JG Maessen, Prof. dr.
role: STUDY_CHAIR
affiliation: Istituto di Ricovero e Cura per Anziani
name: Marco Dellabella
role: STUDY_CHAIR
References:
citation: Crichton, N. Visual analogue scale (VAS). J Clin Nurs. 2001; 10(5): 706-6.
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
citation: Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.
citation: Schwarzer, R., & Jerusalem, M. Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs. Windsor, UK: NFER-NELSON. 1995; 35-37.
citation: Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
citation: Brooke, J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996; 189(194): 4-7.
citation: Reichheld FF. The one number you need to grow. Harv Bus Rev. 2003 Dec;81(12):46-54, 124.