Clinical Research Directory

Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Diabetes Mellitus Tunisian Patients

The study aims to evaluate the impact of a telemonitoring system on glycemic control in patients with diabetes in Tunisia. Participants in the intervention group will receive remote diabetes management through a dedicated mobile application and web platform, while the control group will receive standard diabetes care. The primary objective is to determine the effectiveness of telemonitoring in improving glycemic control, as assessed by changes in glycated hemoglobin (HbA1c) and blood glucose levels.

Continuous Vital Sign Monitoring in a Surgical Ward

Unsafe patient care remains a major contributor to global morbidity and mortality. In surgical wards, postoperative patients are typically monitored intermittently using the National Early Warning Score (NEWS-2), leaving periods during which clinical deterioration may go undetected. Continuous vital sign monitoring (CVSM) using wearable sensors offers the potential for earlier identification of deterioration compared with intermittent assessments. CVSM was introduced in a hospital ward as part of a hospital-initiated pilot implementation and is used alongside standard monitoring with NEWS-2. The purpose of the study is to evaluate this implementation. This observational study uses a pragmatic, quasi-experimental, multi-method, longitudinal design. The overall aims of the study are to evaluate the impact of CVSM implementation on patient outcomes, to explore healthcare professionals' perceptions of patient safety culture, turnover intention and pleasure of work, and to describe their experiences with implementation.

EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE

Background: Chronic heart failure represents a major public health challenge, affecting approximately 64 million people worldwide and generating high costs in terms of mortality, frequent hospitalizations, and medical expenses. In France, this disease is expected to cause nearly 70,000 deaths and 181,000 hospital admissions in 2022. Current management, based on periodic consultations, fails to effectively prevent acute exacerbations, highlighting the importance of technological solutions such as remote monitoring. Objective: This study aims to demonstrate the value of regular monitoring of electrophysiological and mechanical cardiac signals and parameters in patients with chronic heart failure. Its goal is to build a database of signals from an external measuring device (MyHeartSentinel MHS) to identify parameters that evolve in relation to biological and/or hemodynamic changes and/or the patient's clinical status. The results of this study will enable the further development of an automated monitoring solution for heart failure patients to enable early detection and management of decompensation. Materials and Methods: A total of 70 patients diagnosed with chronic heart failure will be included, including 30 patients hospitalized for heart failure decompensation and 40 patients hospitalized for hemodynamic assessment. Electrophysiological and cardiac mechanical data will be collected using a skin-based measuring device. These data will then be correlated with biological and/or hemodynamic changes and/or the patient's clinical status. They will contribute to the training of an algorithm to detect the risk of decompensation. Hypothesis Tested: Ability of MHS to detect electrophysiological and cardiac mechanical data related to cardiac decompensation, such as cardiac filling pressure.

Study of a Patient Cohort Following Digestive Surgical Care After the Implementation of a Telemonitoring and Tele-coordination Platform for Medical, Paramedical, and Social Management

Postoperative hospital stays and complications vary widely after digestive surgery. Enhanced Recovery After Surgery (ERAS) protocols have shortened stays and accelerated recovery after elective procedures, but they remain challenging in emergency surgery and among frail or elderly patients. While theoretical discharge after colorectal surgery is possible between postoperative days 2 and 7, average stays in practice are 12-14 days. Bariatric surgery similarly targets discharge on days 2-3, yet typical stays are 8-10 days. Patients successfully managed under ERAS may face higher readmission risk, often due to worsening comorbidities or serious complications. Prolonged hospitalization and readmissions impact patient safety, comfort, and healthcare costs. Daily hospital costs in surgical units range from €350 to €400. Post-acute care facilities can reduce readmissions but often have long waiting periods. To minimize readmission risk, many surgeons prefer in-hospital postoperative monitoring, limiting early discharge. Recent studies show that connected devices and teleconsultation can provide safe and effective postoperative follow-up. Teleconsultation follow-up is feasible for most patients, with satisfaction rates comparable to in-person visits. Remote monitoring of stoma care has been associated with reduced readmissions. Home-based monitoring using connected vital sign devices in high-risk patients reduces readmissions and emergency visits. In colorectal and bariatric surgery, daily remote monitoring after early discharge (24-48 hours) did not increase morbidity or readmission, suggesting that telemonitoring can safely enable earlier discharge while maintaining patient safety. Continuous monitoring is particularly important for high-risk patients due to rapid deterioration from potential complications. EPOCA is a telemonitoring and telecoordination platform providing medical, paramedical, and social follow-up at home. It combines connected devices, a digital platform for data analysis, and a dedicated medical and paramedical team. Services include teleconsultations, home paramedical care, support for families or care facilities, and 24/7 emergency management. EPOCA reassures patients and caregivers, supports primary care and home care teams, and integrates hospital and emergency services. It addresses challenges posed by aging populations, chronic disease prevalence, and increasingly complex patients. By enabling earlier discharge without increasing readmissions, EPOCA offers a holistic solution bridging hospital and home care. It has already demonstrated success in preventing hospitalizations in high-risk elderly patients and is authorized for telemonitoring of chronic conditions including diabetes, respiratory, renal, and cardiac insufficiency. This study aims to evaluate the feasibility of implementing EPOCA over two years in the CHU Nantes digestive surgery unit. It will target patients undergoing elective or urgent colorectal or bariatric surgery who are at risk of prolonged hospitalization or readmission. High-risk scenarios include anticipated early discharge within 24 hours and patients identified as having elevated readmission risk according to predefined criteria

TOD-IBD: Empowering Patients On-Demand

Crohn's disease and Ulcerative Colitis, collectively known as Inflammatory Bowel Disease (IBD), impose a significant burden on patients and healthcare systems due to their chronic nature and complex treatment. This study aims to assess the effectiveness and safety of on-demand telemonitoring, as opposed to standard fixed-schedule telemonitoring, in managing IBD. The primary objective is to evaluate the impact of on-demand telemonitoring on the number of persistent flares over 12 months. The study involves a multicenter randomized controlled trial comparing standard telemonitoring, which includes regular completion of the Monitor IBD At Home questionnaire and fecal calprotectin home tests, with on-demand telemonitoring where patients use the app based on their symptoms. The study population includes adult patients with stable remission on maintenance therapy. Disease activity, measured by unplanned healthcare contacts, is the primary outcome, while secondary outcomes encompass clinical and patient-reported disease activity, quality of life, self-efficacy, patient activation, total healthcare contacts, safety, and costs. Baseline characteristics include patient, disease, and socio-demographic factors. This innovative approach has the potential to enhance patient autonomy, satisfaction, and self-management, while reducing the overall burden on the healthcare system.

Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care

The overall aim of this research proposal is to explore the feasibility and acceptability of home antenatal maternal-fetal monitoring technology within a high-risk pregnancy group. The investigators hypothesise that home monitoring is feasible and acceptable to both pregnant women and HCPs. 50 women from a single site will be recruited to use a home cardiotocography (CTG) device alongside routine antenatal care. Participants will use this device once a week, for an hour at a time, for up to 6 weeks or until delivery. The primary outcome is 20 minutes of continuous monitoring. Additional outcomes assess acceptability, adherence and safety.

EVOLVING AZIMUTH IN MUSA CONTEXT

Non-pharmacological, randomized, nonprofit medical device intervention. The study aims to identify the positive impacts (co-creation), and negative impacts (co-destruction), resulting from the use of telemedicine, and, in particular, the telemonitoring service for patients with heart failure

Effects of Telemonitoring in Quality of Life Amongst Cancer Patients

This interventional study aims to explore the potential of a smartphone app, Contigo, in enhancing the quality of life for patients with various cancers compared to standard care. The investigators will asses effects on quality of life, depressive symptoms, and appointment adherence.