Stress Management Anxiety Stress
Conditions
Interventions
Patients randomly assigned to intervention group will be exposed to the use of
CARINAE for 4 months approximately, a patient-centred digital health support
program. This program delivers the followi
Sponsors
Salumedia Labs
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Patients planned for one of the selected surgery types: o Cardiopulmonary bypass (CPB) surgery (Maastricht UMC+) o Coronary artery bypass surgery (Maastricht UMC+) o Cardiac valve replacement (SAS, Maastricht UMC+) o Prostate, kidney, and bladder cancer surgery (INRCA) o Hip and knee replacement (HSJD; Parc Tauli) o Maxillofacial surgery (HSJD) o Orthognathic surgery (HSJD) o Scoliosis (HSJD) • Signed informed consent (by patient or legal guardian in paediatric cases). • Patients >= 18 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
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Dementia. • Pregnant women. • Categorized > ASA IV. • Inability to understand the local language. • Allergic to dedicated wearable material (stainless steel and silicone). • Currently enrolled in a different clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For assessing the main objective of the study, a personalized stress and anxiety intervention based on technologies and artificial intelligence will be performed to patients and caregivers belonging to intervention group from the enrolment to the follow up at 14 days after the operation. The objective of this personalized intervention will be to gather quantitative information to better understand individualized experiences of patients undergoing major surgeries and also experiences of their caregivers. Moreover, barriers and facilitators for the adoption of the CARINAE solution perceived by patients, caregivers and healthcare professionals will also be examined. This personalized intervention will be based on mental health and technology acceptance theoretical framework based on previous works (Mohr et al., 2014). The personalized intervention will be recorded upon the consent of the participant. During the personalized intervention, the research team through an automatic AI-algorithm will analyse the performance in order to provide personalized contents. This analysis will target subjective experiences, perceived challenges and barriers related by the participants, including the sentiment analysis for positive and negative perceptions of specific topics and the whole CARINAE solution. | — |
Secondary
| Measure | Time frame |
|---|---|
| For assessing the secondary objectives, the following study parameters will be used: • Patients* and caregivers* self-reported stress will be measured by a Visual Analogue Scale (VAS) for stress measurement at enrolment (baseline), at admission for surgery, at hospital discharge, and 2 weeks after the surgery. • Patients* self-reported pain will be measured by a Visual Analogue Scale (VAS) for pain measurement at enrolment (baseline), at admission for surgery, at hospital discharge, and 2 weeks after the surgery. • Patients* health-related quality of life (HRQoL) will be measured by the evolution of the EQ-5D-3L questionnaire at enrolment, admission for surgery and at clinical discharge. • Patients* emotional status will be measured at enrolment (baseline), at admission for surgery, at hospital discharge, and 2 weeks after the surgery. • Patients* and caregivers* mental wellbeing will be measured at enrolment and 2 weeks after the surgery by means of the SWEMWBS questionnaire. • Patients* and caregivers* self-efficacy will be measured at enrolment and 2 weeks after the surgery by means of the GSE-SF questionnaire. • Patients* activation status will be measured by means of the Patient Activation Measure short form (PAM-13) self-reported questionnaire at enrolment, admission for surgery and 2 weeks after the surgery. • Data on patients* medication use will be gathered at enrolment and 2 weeks after surgery by pulling this information from the patient*s Electronic Health Record (EHR). • Patients* length of hospital stay will be measured in natural days from admission to surgery to hospital discharge. • Data on patients* health outcomes (post-operative complications, re-operations and mortality) will be measured 2 weeks after the surgery by pulling this information from the patient*s EHR. Usability will be checked per phase: pre-hospital, hospital stay, and post-hospital. For those participants allocated to the intervention group and health | — |
Countries
Netherlands
Outcome results
None listed