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.

Symptoms and General Pathology

Wounds and Injuries

Neoplasm Metastasis

Joint Dislocations

Hip Dislocation

Gastrointestinal Agents

All Drugs and Chemicals

Cimetidine

Subjects in this arm will receive a constrained liner with one of the following implants: Freedom Constrained Acetabular Liner (Zimmer Biomet), G7 Freedom Constrained Acetabular Liner (Zimmer Biomet) or Lubinus Acetabular Cup with a safety ring (LINK)

Constrained Liner

Subjects in this arm will receive a dual mobility cup with the following implant: Avantage Dual Mobility Cup (Zimmer Biomet)

Dual Mobility

Afrim Iljazi, MD

The purpose of the current study is to investigate whether dual mobility liners are non-inferior til constrained liners regarding the post-operative hip joint dislocation risk following total hip replacement in patients with metastatic bone disease of the hip.

The use of constrained liners in total hip arthroplasty (THA) in patients with metastatic bone disease of the hip (MBD) has increased at our department in recent years to avoid hip dislocation in this high-risk population. Hip surgeons seldom recommend the use of constrained liners in primary surgery due to the risk of polyethylene wear and high revision rates. An alternative to constrained liners are dual mobility cups, which have been shown to decrease the risk of dislocation in other high-risk THA operations such as revision THA and THA in hip fracture patients, while providing the added benefit of a less restricted range of motion of the joint. This study will investigate whether dual mobility cups are non-inferior to constrained liners regarding the post-operative joint dislocation risk in patients with MBD.

A Randomized, Open-Label, Two-Arm, Non-Inferiority Study

Fully Constrained Acetabular Liner vs. Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip

Fully Constrained Acetabular Liner Versus Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip - A Randomized, Open-Label, Two-Arm, Non-Inferiority Study Evaluating the Post-Operative Hip Dislocation Rate

The 1-year and 2-year hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

The 1-year and 2-year implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

The 1-year and 2-year overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

The incidence of post-surgical and prosthesis-related complications in patients receiving a dual mobility cup compared to patients receiving a constrained liner. These include but are not limited to deep venous thrombosis, pulmonary embolism, wound infections, periprosthetic infections, periprosthetic fractures etc.

The 1-year and 2-year Karnofsky Performance Status Score in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point.

The 1-year and 2-year MSTS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point

The 1-year and 2-year HHS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point

The 1-year and 2-year Eq-5d score in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point

The 1-year and 2-year TESS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point

The 6-months hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner for the surgical treatment of MBD

The 3-months hip dislocation rate in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

The 3-months and 6-months implant survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

The 3-months and 6-months overall survival in patients receiving a dual mobility cup compared to patients receiving a constrained liner.

The 3-months and 6-months Karnofsky Performance Status Score in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point.

The 3-months and 6-months MSTS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point

The 3-months and 6-months HHS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point

The 3-months and 6-months Eq-5d score in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point

The 3-months and 6-months TESS in patients receiving a dual mobility cup compared to patients receiving a constrained liner and who are alive at the defined time point

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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.
Fully Constrained Acetabular Liner vs. Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip	NCT05461313	Metastatic Canc...	Constrained Lin... Dual Mobility	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for hip replacement