Clinical Research Directory

Virtual Menstrual Pain Approaches in Females

This research study is testing two self-care approaches that may help prevent or reduce period pain in young females with primary dysmenorrhea, a common condition that causes painful menstrual cramps. Participants will be placed by chance into 1 of 3 groups: auricular acupressure, Baduanjin qigong, or a self-care education comparison group. The auricular acupressure and Baduanjin groups will receive online training and then practice the treatment on their own for 12 weeks. The main question is whether these two approaches can reduce the severity of menstrual pain. The study will also look at whether they can improve other symptoms that often happen with period pain, such as tiredness, poor sleep, anxiety, low mood, trouble concentrating, and reduced physical function. Researchers will also study stool and blood-related biological markers to better understand whether changes in gut bacteria and body metabolism may be linked to symptom improvement. A total of 145 participants will take part in the study at NTU, and any side effects or other safety concerns will be checked every week.

Chatbot to Support Healthcare Professionals Experiencing Workplace Aggression

This study aims to design, develop, and validate a chatbot (SANIDAD SEGURA) intended to support healthcare professionals who experience workplace aggression. Workplace violence in healthcare settings is a growing global concern and has been associated with negative psychological, professional, and organizational consequences. Despite the existence of prevention and reporting protocols, many incidents remain underreported and affected professionals often lack immediate, confidential access to guidance and support. SANIDAD SEGURA is a digital conversational agent designed to provide accessible information, guidance, and referral to institutional, psychological, and legal resources following aggressive incidents. The study will evaluate the usability, readability, and preliminary effectiveness of the chatbot among healthcare professionals working in emergency and critical care units. The study seeks to determine whether a chatbot-based tool can serve as a feasible and acceptable digital resource to assist professionals exposed to workplace aggression and facilitate access to support resources while contributing to improved reporting and understanding of workplace violence in healthcare settings.

Impact of the Corrie Lipids Digital Health Program on Lipid Optimization

The overall objective is to evaluate the effectiveness and implementation of the Corrie Lipids Program, a comprehensive digital health initiative designed to address critical gaps in lipid-lowering as a component of ASCVD treatment by delivering an intervention that combines a patient-facing smartphone app, clinician education and coaching, and seamless incorporation into clinical workflows. Researchers plan to assess this multicenter digital health initiative in approximately 1,000 adults with uncontrolled LDL-C and elevated ASCVD risk using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The study will examine whether the program improves LDL-C goal attainment, app engagement, prescribing patterns, and LDL-C monitoring, while also identifying barriers and facilitators to implementation across sites.

Remote Cardiovascular Monitoring in Post-TAVI Patients

The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce both postprocedural hospital length of stay and readmissions. This strategic integration of technology aims to address gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care. One significant concern after TAVI is the development of heart conduction abnormalities on the ECG and abnormal rhythms, such as heart block, potentially requiring permanent pacemaker insertion. Addressing these rhythm issues is crucial for reducing the overall length of stay. The main question it aims to answer is: Does a remote patient monitoring protocol-driven strategy reduce post-TAVI hospital length of stay and adverse events? Participants post-TAVI procedure and eligible for same-day discharge, as determined by their primary cardiologist, will be randomized upon informed consent into the active arm (remote monitoring) or control group (standard of care). Participants in the active arm will: receive four remote monitoring devices. Receive support from a validated clinical decision-making algorithm for further management. Participants in the control group will: adhere to the best standard of care as per current practice. Researchers will compare the active arm to the control group to see if the remote patient monitoring protocol-driven strategy reduces post-TAVI hospital length of stay and adverse events.

Self-administered Remote Neurological Examination Using Mobile Application in Patients With Brain Tumors

The goal of this observational study is to evaluate the feasibility and accuracy of a self-administered remote neurological examination using the "Iskhaa" mobile application in patients with brain tumors aged above 5 years who are able to follow app-based instructions. The main questions it aims to answer are: 1. Development of a mobile application equipped with symptom assessment and recording videos as patients perform specific neurological tasks. 2. Development and validation of the AI model to detect functional changes and predict subsequent neurological deterioration. Participants will: 1. Use the Iskhaa mobile application to perform guided self-neurological examinations following pre-recorded video instructions. 2. Complete EORTC QLQ-C30 and BN20 questionnaires for quality of life assessment. 3. Record and upload videos (e.g., speech, walking, limb movements) using their mobile camera for analysis. 4. In Phase 1 (onsite), 100 participants will use the app under supervision to ensure usability and accuracy. 5. In Phase 2 (offsite), 500 participants will use the app independently at home for monthly self-assessments, with reminders and follow-up support. 6. Continue routine clinic visits every 3-6 months and imaging every 6-12 months as per standard clinical care. The study will compare app-recorded data with physician assessments to determine agreement and validity of remote neurological monitoring using artificial intelligence analysis.

The Effectiveness of AIFIGA Program on Nursing Home Nursing Staff and Family and Residents'Health

This study aims to develop and evaluate the longitudinal effectiveness of the Artificial Intelligence Family Involvement Generative Agent (AIFIGA) program in enhancing the health of nursing staff, family, and residents' health through the use of a sequential, mixed methods research design. The development of a real-time, interactive, and informative AIFIGA program that sparks innovation is necessary to achieve effective communication between families and nursing staff. In Phase I, lasting 18 months, we will develop the AIFIGA program based on triangulate research design, observation and in-depth interview understanding the daily communication experiences and expectations from both families and nursing staff perception in Nursing Homes(NHs) after COVID-19, as well as our previous years' research results. The training data for AIFIGA will be derived from the collection of communication dialogues in these qualitative data. Furthermore, the intelligence of AIFIGA will be developed using publicly available large language models (LLMs). In Phase II, spanning the next 18 months, we will evaluate the longitudinal effects of the AIFIGA program on the health of residents, families, and nursing staff, tracking changes over time (baseline, 1 month, 3 months, and 6 months). There will be two groups of participants: (a) an AIFIGA group that receives the AIFIGA program and uses it for 3 months, and (b) a control group that receives only routine care.

Trust in AI and Digitalization in Healthcare Across Generational Groups: A Comparative Study of Barriers and Facilitators Toward Equitable Adoption.

This study aims to investigate differences in perception of barriers and facilitators of digitalization and Artificial Intelligence (AI) usage in healthcare across different generational groups (youth, working-age adults, and seniors). The results will help create practical recommendations for public health projects and consultants to support fair and inclusive use of new digital tools in healthcare. A cross-sectional online survey will be conducted among students at HAW, patients and employees in the rehabilitation center in Oldenburg, and seniors participating in the "Digital im Alter"(DIA) project.

Integrated TCM - Western Medicine Strategy for Long - Distance Diabetes Management

The management of diabetes is of great value in reducing the risk of complications and alleviating the socioeconomic burden. Currently, the diabetes management models in China have not effectively integrated the advantages of traditional Chinese medicine (TCM) and Western medicine. They also fail to achieve intelligent and automated management, resulting in high management costs and low efficiency. Therefore, it is extremely urgent to explore a new, efficient, convenient, low - cost, and personalized long - distance, full - course, intelligent management model for diabetes that integrates TCM and Western medicine both online and offline. Based on this, our research group plans to rely on the pre - designed and developed Idata database. We will deeply integrate the diagnostic and treatment advantages of TCM constitution differentiation and Western medical examinations and laboratory tests, construct an automated follow - up path, and build an integrated online diabetes management platform for Internet hospitals, which consists of "intelligent hardware + APP + cloud services + a back - end think - tank of TCM and Western medicine experts + a back - end professional management and care team". This initiative aims to blaze a new trail in the field of long - distance, full - course, and personalized management of diabetes through the synergy of TCM and Western medicine for Chinese diabetes patients. We expect to significantly reduce the incidence of diabetes complications, remarkably improve the overall health status and quality of life of patients, and bring unprecedented positive impacts on the well - being of diabetes patients.

Wearable Technology and Machine Learning for Early Detection and Risk Assessment of Unacceptable Toxicities in a Paediatric Oncology Cohort

Data collection study to establish a predictive model of infection observed during childhood cancer therapy using data captured by wearable technology.

Impact of a Technology Platform Based on Enhanced Recovery After(ERAS) Surgery on Length of Stay After Coronary Artery Bypass Grafting: Timely Project

Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. One of the well-established treatments is coronary artery bypass grafting, which is the most performed among cardiac surgeries and, in our scenario, is primarily funded by the Unified Health System (SUS). The information obtained from the Paulista Registry of Cardiovascular Surgeries (REPLICCAR), in partnership with FAPESP, has been important for implementing improvements in the landscape of cardiac surgeries in the state of São Paulo. Although outcomes in cardiac surgery have improved due to the structuring and organization of quality programs, this is still not a reality at the national level. In a situation where data collection and quality initiatives play a central role in continuous improvement, generating value becomes essential for the sustainability of cardiac surgery programs. In this sense, the concept of Enhanced Recovery After Surgery (ERAS) has gained increasing traction. This concept is based on multidisciplinary protocols and scientific evidence, which help prepare patients for rapid recovery, resulting in reduced complications, shorter hospital stays, and, primarily, lower hospital costs. On the other hand, the increase in surgical waiting lists has also led to a rise in home mortality due to cardiac causes. Thus, among the various challenges imposed by the current scenario, the investigators believe that preparing patients for rapid recovery after coronary artery bypass grafting presents an opportunity for the sustainability of the healthcare system. Therefore, the aim of this project is to evaluate the impact of a technology platform based on ERAS on the postoperative recovery time of patients undergoing coronary artery bypass grafting in reference centers in the state of São Paulo, Timely Project - REPLICCAR III.

Using Digital Health in a Postoperative Setting After Major Surgery: Survey Study

This study aims to explore patients' use of digital services for self-management of their health following major surgery at Jessa Hospital. Besides this, the study evaluates patients' ability to process and critically assess health information during recovery, their understanding of health concepts and risk factors, and their perception of data security and control over personal health information. Additionally, the study aims to examine patients' motivation to use digital services, their access to and trust in reliable digital health resources, and how well these services meet their individual needs. Furthermore, the study assesses the acceptability, appropriateness, and feasibility of using digital health tools in a post-operative setting, as well as evaluating the digital readiness of patients after surgery.

Remote Clinical Monitoring After Robotic Distal Pancreatectomy

This feasibility trial has three main objectives: * To investigate the impact of the transmural care pathway TOTeM on the Length of Stay (LOS) for patients undergoing robotic distal pancreatectomy. * To investigate the feasibility of the implementation of TOTeM for patients undergoing robotic distal pancreatic surgery, we will measure the recruitment rate by tracking the number of eligible patients who are approached for participation, the percentage who consent to join the study over a specified time period, and the adherence rate which describes how well participants follow the study protocol including the prescribed interventions or follow-up assessments. * Assessment of the potential changes in medical costs and outcomes for the purpose of performing a cost-effectiveness analysis from a hospital and patient perspective.

Development of an International Remote Digital Care System for Accessible, Inclusive and Sustainable Pregnancy Care

Pregnancy care is under increasing pressure due to a rising number of women needing medical care, a shortage of obstetric healthcare professionals, and growing healthcare costs. For women with high-risk pregnancies, this often leads to frequent hospital visits or admissions for monitoring, which can be stressful and time consuming. Remote digital care offers a promising alternative by allowing pregnant individuals to perform monitoring from home while remaining under medical supervision. This study will evaluate the use of telemonitoring in pregnancy care in four European hospitals. Participants with high-risk pregnancies who require frequent cardiotocography (CTG) monitoring and blood pressure (BP) measurements will use certified home devices to record fetal and maternal health data. Instead of hospital-based monitoring, CTG and BP measurements will be performed at home and assessed by trained healthcare professionals. The main purpose of the study is to investigate whether home monitoring is a safe and acceptable alternative to in-hospital monitoring, and to identify what is needed for successful national and international implementation of remote digital pregnancy care. The investigators will collect clinical and implementation outcomes. By doing so, this study aims to keep pregnancy care accessible for all women, improve patient well-being, and reduce pressure on the healthcare system.

Nurse-Led Telehealth for Gout

The aim of this clinical trial is to evaluate whether nurse-led telehealth support helps individuals with gout better manage their condition and adhere to urate-lowering medication after discharge from a rheumatology clinic. Eligible patients will be recruited from five rheumatology departments in the Central Denmark Region after achieving two consecutive target serum urate levels-below 0.36 mmol/L, or below 0.30 mmol/L for patients with tophi. Participants will be adults with gout who meet specific medical criteria, are taking medications such as allopurinol or Adenuric, and are able to read and write Danish. Participants will be randomly assigned to one of two groups: * Intervention group: nurse-led telehealth support. * Control group: usual care with follow-up by their general practitioner. The primary goal is to support patients in maintaining healthy uric acid levels after 52 weeks. Participants in the nurse-led group have the option to choose from four support options: I1: App-Based Support - an app provides information and reminders. I2: Letter Reminders - messages are sent via digital or postal mail. I3: Text Reminders - SMS messages are sent every three months. I4: Phone Support - nurses call three times a year to check in.

Digital Transformation of Continuity of Care for Peripherally Inserted Central Catheters: SpadCare Experience

The study focuses on patients who require outpatient infusion of therapy ("Infusions, Intravenous"\[Mesh\]) "Administration, Intravenous"\[Mesh\] ("Home Infusion Therapy"\[Mesh\]) "Parenteral Nutrition, Home"\[Mesh\] via a peripherally inserted central catheter (PICC) ("Central Venous Catheters"\[MeSH\] "Catheterization, Central Venous"\[MeSH\] "Catheterization, Peripheral" \[MeSH\] "Vascular Access Devices"\[Mesh\] )

InTake Care: Development and Validation of an Innovative, Personalized Digital Health Solution for Medication Adherence Support in Cardiovascular Prevention

Inadequate medication adherence (MA) in chronic conditions, including cardiovascular prevention, represents an important risk factor. The use of new IT technologies in this setting is supposed to be useful to improve patients' adherence, but currently available solutions have significant limitations, including lack of personalization and reliance on expensive ad hoc systems. This interdisciplinary project aims to verify the hypothesis that in patients on chronic antihypertensive treatment MA can be improved through the implementation of a novel digital health solution for MA monitoring and support, based on inexpensive and user-friendly, commercially available technology (voice assistant), connected with web interface for the physician. The intervention will be personalized based on the creation of Personas, intended as multidisciplinary-based representations of different user types. This approach will be tested in a randomized clinical trial.

Digitally Delivered Treatments to Reduce Chronic Low Back Pain

This study aims to evaluate the effectiveness of pain education and clinical hypnosis delivered via a mobile app compared to a guideline-informed factsheet for reducing pain and disability in people experiencing chronic low back pain attending general practice.

Empowering Healthy Lifestyle Personalised Intervention to Prevent and Control Obesity: The HealthyW8 Project

The goal of the HealthyW8 study (an intervention study) is: To assess the usefulness and effects of a digital-based healthy lifestyle recommender system (HRLS) on the prevention of obesity in the following propulations: schoolchildren (5-10 y) and their parents, young adults (18-25 y) and elders (\>65 y). The main questions it aims to answer are: Outcome 1: To select and validate a tool-assisted 3-mo intervention (mostly digital) by iteratively testing the HLRS on reducing risk of overweight/obesity among the described age groups. Outcome 2: To assess the effect of 1-y interventions (mostly digital) with the HLRS described and further iteratively improved previously (outcome 1) on reducing risk of overweight/obesity at described ages. Researchers will compare the intervention group before the intervention (baseline) and after it (3-mo intervention trial), or control group (standard care) vs. Intervention group (1-y intervention) to see changes on changes in overweight/obesity, and related parameters (body composition and biomarkers). Participants will follow the HLRS recommendations (meal plans, physical activity and sleep pattern measures and recommendations, assessment of behavioural/psychological aspects, and motivational features through digital devices), which will be assessed by means of measurement of body weight, body composition, and biomarkers.

Using Digital Health in a Postoperative Setting After Major Surgery: Semi-structured Interview Study

This study aims to evaluate whether patients recognize a need for a remote monitoring care pathway during the post-operative period following major surgery at Jessa Hospital by means of a semi- structured interview. Besides this, the study explores patient perceptions and willingness to participate in digital monitoring care pathways, identifies potential barriers to adoption, and addressing concerns related to safety, data security, and privacy. Additionally, the study aims to assess patient needs regarding parameter collection, technology usage, and the overall functionality of digital monitoring systems, while evaluating the perceived usefulness of such a pathway in post-operative care.

Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep

The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens. This new prototype will have addressed issues that adolescents who had used the first version of the program deemed to be barriers to engaging with the treatment.

Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism

Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention. The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of pulmonary thromboembolism (PTE) on the long-term outcome of PTE patients, in order to enhance clinical practice and establish a foundation of evidence for managing patients with PTE.

Feasibility of a Digital Intervention for Patients Frequently Admitted to Psychiatric Acute Wards

This qualitative feasibility study investigates a digital health app designed for patients who are frequently admitted to the psychiatric acute ward, to facilitate crisis support outside of office hours to avoid unnecessary readmissions, as well as self-harm. As this is a novel app to be implemented in an already existing service, key uncertainties regarding the intervention content and its delivery needs to be addressed before potentially conducting a full-scale trial, or, alternatively, to inform further intervention refinement. Such uncertainties are appropriate to explore in a feasibility study according to the Medical Research Council (MRC) framework for the development and evaluation of complex interventions. There is a need to investigate whether the app is acceptable and useful to the patients using it, and to the healthcare providers who respond to it. There is also a need to know whether the healthcare providers responding to the app find the task manageable. The context in which the staff are to deliver the intervention, i.e. the in-bed ward, may be subject to different barriers, such as a staff shortage due to sick leave and heavy workload in the ward. Such barriers are essential to identify ahead of possible future trials in other contexts.

Smart Technology Facilitated Patient-centered Venous Thromboembolism Management

Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention. The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE.

Increasing Physical Activity Among Medical Inpatients by Digital Nudging of Patients and Staff

Sedentary behaviour among medical inpatients is strongly associated with hospital-associated functional decline and poses a severe threat to patients' functional capacity and independency. High human and socioeconomic costs underline the urgency to find solutions to this world-wide problem. Objective: This multicentre study, including a total of 400 patients from Copenhagen, Aalborg, Tórshavn, and Nuuk, will assess the effect of a digital intervention that aims to reduce sedentary behaviour and increase physical activity in medical inpatients. Intervention: Digital feedback and nudging regarding the patients' physical activity levels to patients and healthcare staff Design: Stepped-wedge cluster randomised multicentre trial Primary outcome: Daily average time of patients' physical activity (minutes).