CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
SaMD CARINAEdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05184725
NCT05184725N/ACompleted

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

Adhera Health, Inc.·interventional·Posted Jan 11, 2022·Updated Aug 1, 2022

In Brief

A clinical study evaluating SaMD CARINAE for Psychological Stress and 10 related conditions. Completed, enrolled 50 participants across 5 sites in 3 countries.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 11, 2022
Enrollment StartJan 10, 2022
Primary CompletionApr 30, 2022
Study CompletionMay 31, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.5 years ago

Interventions

SaMD CARINAEdevice

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.