Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Musculoskeletal Diseases

Behaviors and Mental Disorders

Rare Diseases

Prostatic Neoplasms

Urinary Bladder Neoplasms

Scoliosis

Carcinoma, Renal Cell

Stress, Psychological

Kidney Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Spinal Curvatures

Spinal Diseases

Bone Diseases

Kidney Diseases

Behavioral Symptoms

Renal Cell Carcinoma

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).

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.

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.

SaMD CARINAE

Clara Hernández Cera

Ignacio Muñoz Carvajal

Juan José Lázaro Alcay

Andrea Vallejo Tarrat

JG Maessen, Prof. dr.

Marco Dellabella

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.

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.

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.

CARINAE for Stress Relief in Perioperative Care

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

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.

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.

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.

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.

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.

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.

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.

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.

Questionnaire on SaMD CARINAE usability by patients, caregivers and healthcare professionals

Ad-hoc questionnaire for patients and healthcare professional on the digital solution usability

Net Promoter Score (NPS) is a questionnaire that measures patient and healthcare professionals experience and provides the core measurement for customer experience management programs.

Ad-Hoc questionnaire for the healthcare professional on the digital solution

Maastricht University Medical Center

Hospital Sant Joan de Deu

Parc Taulí Hospital Universitari

Hospital Universitario Reina Sofia de Cordoba

Istituto Nazionale di Ricovero e Cura per Anziani

Adhera Health, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

LDCT was performed at baseline + 2 biennial repeated LDCT rounds

LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm

Low Dose Computed Tomography

AI was performed in high-risk individuals recruitment and lung nodules management

artificial intelligence (AI)

AFI applied in screening of centrally located SCC.

autofluorescence imaging (AFI)

Baohui Han, MD Dr.

Yanwei Zhang, MD Dr.

Baohui Han

Our previous study, china lung cancer screening study version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). The present one arm study is performed to evaluate the efficacy of new techniques in improving the implementation of lung cancer screening and validate our previous findings. 6000 high-risk subjects (age 45-75) were recruited to take LDCT screening. (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.

China Lung Cancer Screening (CLUS) Study Version 2.0

Community-based Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 2.0

Assess lung cancer mortality within next 5 years after first round of screening

Evaluate the ability of AI in enhancing the attendance rate of high-risk individuals

Evaluate the ability of AI, AFI and molecular biomarkers in enhancing the diagnostic accuracy rate of lung cancer

Assess all-cause mortality within next 5 years after first round of screening

Assess lung nodules detection rate, and the types and sizes of nodules detected in LDCT screening

Assess the number of lung cancer incidences after each round of screening

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CARINAE for Stress Relief in Perioperative Care	NCT05184725	Psychological S... Cardiopulmonary... Coronary Artery... Cardiac Valve R... Hip Replacement Orthognathic Su... Scoliosis Knee Replacemen... Prostate Cancer Kidney Cancer Bladder Cancer	SaMD CARINAE	8 Years -	Adhera Health, Inc.
China Lung Cancer Screening (CLUS) Study Version 2.0	NCT03975504	Lung Neoplasms	Low Dose Comput... artificial inte... autofluorescenc...	45 Years - 75 Years	Shanghai Chest Hospital
China Lung Cancer Screening (CLUS) Study Version 2.0	NCT03975504	Lung Neoplasms	Low Dose Comput... artificial inte... autofluorescenc...	45 Years - 75 Years	Shanghai Chest Hospital
China Lung Cancer Screening (CLUS) Study Version 2.0	NCT03975504	Lung Neoplasms	Low Dose Comput... artificial inte... autofluorescenc...	45 Years - 75 Years	Shanghai Chest Hospital
China Lung Cancer Screening (CLUS) Study Version 2.0	NCT03975504	Lung Neoplasms	Low Dose Comput... artificial inte... autofluorescenc...	45 Years - 75 Years	Shanghai Chest Hospital

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