Clinical Research Directory

The Effect of Digitally Enabled District (DED 2.0) Ecosystem on the Completeness and Timeliness of Maternal and Neonatal Services in Primary Health Care

DED 2.0 is a stepped-wedge cluster-randomized trial testing whether an integrated digital health ecosystem (KuApps, a service-monitoring dashboard, AI-assisted OCR for handwritten records, two-way WhatsApp-based health communication, and an automated worker-support tool) improves the completeness and timeliness of maternal and neonatal primary health care services, delivered through 45 Puskesmas in Garut Regency, West Java, Indonesia.

BMT4me: Post-HSCT Medication Adherence mHealth App

This is a mixed methods, prospective longitudinal pilot RCT to evaluate the 1) acceptability of a newly developed mHealth app (BMT4me), 2) the feasibility of enrolling and retaining caregivers of children in the acute phase post-HSCT, and 3) the potential efficacy of an mHealth app on adherence to immunosuppressants in post-HSCT children discharged during the acute phase.

AI-Generated Video Distraction Via Virtual Reality for Fear and Pain During Pediatric Circumcision

This randomized controlled trial evaluated the effect of artificial intelligence-generated video distraction delivered via virtual reality on procedural fear and pain in children undergoing circumcision. A total of 80 children aged 4-12 years were assigned to an intervention group (n=40) or a control group (n=40). Children in the intervention group received AI-generated video distraction via virtual reality, whereas children in the control group received routine care. Pain and emotional responses were assessed from the perspectives of the child, parent, and nurse. Physiological parameters were also measured before and after the procedure. The study aimed to determine whether AI-generated video distraction delivered via virtual reality reduces procedural fear and pain during pediatric circumcision.

Trust in AI and Digitalization in Healthcare Across Generational Groups

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.

Prevention of Ischemic Stroke Recurrence Using Digital Technology Application

The goal of this study is to find out whether a comprehensive management program that uses a smart bracelet and a mobile app can help people who have had an ischemic stroke (a type of stroke caused by a blocked blood vessel in the brain) to prevent another stroke. The investigators also want to see whether this program helps with controlling blood pressure, blood sugar, and blood lipids, as well as with taking medications correctly, improving daily habits, and supporting emotional well-being. The investigators are focusing on two main questions: * After using this digital management tool, will the chance of having another stroke within one year after leaving the hospital be lower? * Compared with people who only receive regular care, will those who use the tool show better control of blood pressure, blood sugar, and blood lipids, better medication adherence, and healthier lifestyles? People who join the study will be randomly assigned to one of two groups. One group will receive usual stroke prevention care (the control group). The other group will get the same usual care plus an additional 12-month program that includes a smart bracelet and a mobile app (the intervention group). If participants are in the intervention group, participants will: * Wear a smart bracelet continuously and use a mobile app for 12 months. * Receive health tips, medication reminders, blood-pressure measurement reminders, activity goals, and vibration alerts when participants have been sitting too long through the app. If participants are in either group, participants will: * Come to the clinic for check-ups and assessments at the start of the study, and again at 3 months, 6 months, and 12 months. * Have neurological function of participants, daily activity abilities, quality of life, medication adherence, and mood (depression and anxiety) assessed at those visits. * Have blood tests to check metabolic risk factors of participants(e.g., blood lipids and glucose) at the same visits. * Report to the research team if participants experience another stroke, any cardiovascular event, or death at each follow-up visit. The investigators will compare the two groups to see if the digital program makes a real difference in reducing stroke recurrence and improving overall health after a stroke.

Multimodal Digital Biomarker Prediction of Acute Clinical Deterioration

Rather than relying on a single abnormal vital sign, the study will examine how multiple physiologic signals change together over time and whether changes in the relationships among these signals provide useful information about impending clinical deterioration. Individual participant physiologic patterns may be characterized longitudinally to account for differences between individuals and changes within the same individual over time. The primary objective is to evaluate the predictive accuracy of multimodal digital biomarkers for protocol-defined acute clinical deterioration occurring within 72 hours. The study is observational and does not assign participants to an investigational treatment.

AI-driven Personalized Exercise Feedback Program on Exercise Adherence in Traumatic Brain Injury

This study aims to develop and evaluate an AI-driven Personalized Exercise Feedback Program (AI-PEF) to enhance exercise adherence and health outcomes in mTBI patients. Methods: AI-PEF integrates the transtheoretical model and self-determination theory with machine learning algorithms to provide real-time, personalized feedback. A phased randomized controlled trial will be conducted: Phase I evaluates feasibility and acceptability through Delphi methods with expert consensus and patient feedback; Phase II validates preliminary outcomes with 30 participants in a 2-arm randomized trial; and Phase III assesses the program's impact on exercise adherence, exercise motivation, mHealth app usability, functional capacity, sleep quality, depressive symptoms, concussion symptoms, and quality of life with 90 participants in a 3-arm randomized trial. In Phase III, quantitative and qualitative data will be collected in parallel, with qualitative data collected through semi-structured interviews to explore participants' experiences and perceptions of the intervention.

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. This study aims to evaluate the effects of a smart technology-assisted, patient-centered mobile health application for pulmonary thromboembolism management (mPEA) on the long-term outcomes of patients with pulmonary thromboembolism (PTE). The findings are expected to inform clinical practice and provide an evidence base for the long-term management of patients with PTE.

Assessing Feasibility of Evaluating Provider Experience With a Remote Therapeutic Monitoring Platform

: Remote therapeutic monitoring (RTM) platforms were increasingly deployed in Outpatient Rehabilitation to support continuous, between-visit communication, adherence to home exercise programs, and earlier identification of clinical setbacks. While patient-facing outcomes have received growing attention, evidence describing the clinician experience of RTM; including its effects on therapeutic alliance, perceived cognitive workload, and capacity for proactive patient management remains limited. Understanding how providers perceive and integrate RTM technology into their workflows is essential to optimizing implementation, sustaining adoption, and translating digital health investment into measurable clinical value. This cross-sectional survey study tested the feasibility of evaluating the provider's experience using a digital RTM platform across three pre-specified domains: 1) therapeutic alliance, 2) work satisfaction, plus cognitive loading, and 3) proactive patient management. A secondary objective examined whether years of clinical experience or self-reported comfort with new technology were associated with provider experience or perceived workload.A cross-sectional, anonymous survey was administered to licensed physical therapists at the Outpatient Clinics, Shebin El-Kom, Menofyia governate, Egypt between 1st March, and 31th July, 2026 with a response rate of 43.4% (43/99) for the completed surveys. Eligible clinicians used the SaRA Health RTM platform for at least the previous six months prior to initiation of current study. The survey instrument combined an internally developed 8-item Likert-scale survey (0-5) targeting therapeutic alliance, proactive management, and satisfaction (Cronbach's α = 0.89) with a modified NASA Task Load Index (NASA-TLX; Cronbach's α = 0.86) measured the perceived workload across six domains (0-10). Cronbach's α coefficient demonstrates internal consistency, unless not construct validity or test-retest reliability. Statistical analyses included Spearman rank-order correlations and Mann-Whitney-U tests. For Mann-Whitney comparisons, results were reported as: U, p-value, group sample sizes (N1, N2), and rank-biserial r-effect size. For multiple comparisons across NASA-TLX subscales (k = 6), a Bonferroni-corrected threshold of α = .0083 was applied. Spearman correlations were reported with ρ and 95% confidence intervals.In this cross-sectional survey feasibility study, it was observed that clinician experience with the SaRA Health RTM platform was characterized by enhanced therapeutic alliance when early warning detection performed well, reduced cognitive load was observed when frustration was low, and meaningful facilitation of proactive patient management was observed among engaged users. Frustration emerged as the most actionable lever for design and implementation improvement, and self-reported digital comfort rather than years of clinical experience was the strongest clinician-level correlate of cognitive burden. These findings suggest that targeted onboarding, mentorship, and friction-reducing platform refinements may improve RTM adoption and amplify downstream benefits to patient care. Larger, multi-site, longitudinal studies are warranted to validate these signals.

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.

The RenAtt Method for Diagnosing and Treating Attention Problems After Stroke and Brain Injury, Further Validation of RehAtt® DiSTRO Assessment of Cognitive and Visual Function

Stroke is one of the most common long-term disabilities in the world. Despite better access to more effective acute treatment, WHO reports a prediction of almost a doubling of disability-adjusted life-years (DALYs) in 2050. In UK about 100 000, in Sweden about 20,000 people suffer a stroke yearly. Cognitive effects after a stroke are issues with the way the brain understands, organises and records information. An overwhelming majority of stroke survivors, and their care givers, report on how these problems are profoundly disabling and their greatest concern. In a survey where more than 10,000 stroke survivors were asked about lived experience after stroke, more than nine out of ten reports on experiences from at least one cognitive domain, such as problems with attention or memory. The prevalence reported varies deeply, depending upon screening methods, severity, and timing after stroke. Prevalence in the acute phase ranges from 49-92%, and at follow-up after 6-12 months, 41-57% The high prevalence of cognitive deficits following stroke and their impact on patients' recovery strongly indicates the value of cognitive screening early after stroke as recommended in clinical guidelines. For the patients and their care givers, it is important to be informed early on about a sudden loss of function has a value to gain insight and be motivated for rehabilitation. The Oxford Cognitive Screen (OCS) is a recommended, first-line cognitive screening designed for use in stroke patients in several international guidelines. For implementation in Sweden a Swedish translation, cultural adaptation and validation was requested. In UK and Italy OCS is recommended in clinical guidliens and broadly used and implemented in paper based form. A challenge to implement OCS is that is time and resourse consuming, about 20 to 60 minutes (preparation, performance of test, scoring and interpretation of results).Following recommendations to use digital health technologies to improve screening efficiency, a tablet OCS was designed and developed. This study includes an equivalence testing of the paper to tablet OCS versions, in subacute stroke and healthy, in UK, Sweden and Italy. Method: The OCS was translated into Swedish following a standardised forward-backward translation process with expert review, to ensure linguistic and cultural accuracy. A digital tablet based version of the OCS was developed and validated. Subacute stroke survivors were assessed with the paper and tablet versions of the OCS-SE (A/B), in a randomised counterbalanced order, assessors blinded to allocation. Normative data were collected from 100 healthy with both methods in Sweden. Further equvalence testing of OCS paper-version to tablet-version was performed in 50 stroke and 100 healthycontrols in Italy and 50 stroke and 100 healthy controls in UK. Performance was compared across modalities using equivalence t-tests to assess the consistency of results. The study validating the tablet OCS was made to improve idenitifcation of cognitive impairments after stroke, to improve accuracy of results, by its computerised support in standardising the procedure, providing continuous access to instructions and the automatic scoring.

HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea

This study tests a mobile application (app) designed to support sexual health and prevent human immunodeficiency virus (HIV) among young men in South Korea. Researchers are interested to learn if the app is acceptable, easy to use, and helpful for young men who have sex with men (MSM). Participants will complete a 15-minute online survey at the start of the study and another 15-minute survey 3 months later. Participants will be randomly assigned to 1 of 2 study groups for 3 months: 1. Intervention Group: Participants receive access to the full mobile app, called Bandi. The app includes health articles, quizzes, community discussion forums, a personal sexual health log, and a clinic finder. 2. Control Group: Participants receive access to a basic version of the app that includes informational articles and the clinic finder only. Researchers will compare both groups over 3 months to see if using the full app leads to higher rates of HIV testing and lower sexual risk behaviors.

Understanding Pathways to Wellness and Recovery in Detroit - Digital Recovery Support Services

The goal of this clinical trial is to learn if digital recovery support services (such as smartphone app) help to support alcohol recovery. We focus on a community of Black and African American people with alcohol use disorder (AUD) who receive in-person recovery support services from a recovery community center. Participants will: * Have an initial 2-hour in-person visit with the research team. During this visit, participants will be asked about themselves and their recovery from alcohol problems. They will also learn about digital recovery resources. * Use digital recovery resources on their own for 12 weeks. * Complete a short, weekly survey about their experience using digital recovery resources. * Have a follow-up 1-hour in-person visit where the researcher asks about again about the participants, their recovery and how they felt about using the digital recovery support services.

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.

Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy

This study will evaluate whether a digital-supported informed consent process improves patient understanding before advanced therapeutic endoscopy procedures. Patients undergoing advanced therapeutic endoscopy are often asked to make decisions about procedures that may be complex and involve important risks, benefits, and alternatives. Standard informed consent is usually provided through discussion with the treating physician. However, this process can vary between clinicians and may be affected by time pressures in busy endoscopy units. In this study, eligible adult patients scheduled for elective advanced therapeutic endoscopy will be randomly assigned to one of two consent pathways. One group will receive standard physician-led informed consent. The other group will receive a digital-supported consent pathway that includes a standardized procedure-specific educational video, an offline artificial intelligence-based question-answering tool, and final confirmation with the treating physician before the procedure. The digital tool is designed to provide plain-language information about the procedure, including why it is being done, expected benefits, common and serious risks, alternatives, what to expect before and after the procedure, and the patient's right to ask questions or decline the procedure. The AI question-answering tool will use only investigator-approved educational content and will not provide individualized medical advice. Questions requiring patient-specific medical judgment will be directed back to the treating clinical team. The main outcome of the study is patient comprehension of the consent information, measured after the assigned consent process and before the procedure. The study will also evaluate patient anxiety, satisfaction, confidence in decision-making, usability of the consent process, workflow outcomes, and consent-related safety or ethical concerns.

Changing Outpatient Diabetes Care With Remote-Patient-Monitoring: A Real World Evidence Study With Pre-Post Comparison

The goal of this observational pre-post study is to evaluate a remote-patient-monitoring-system (RPM-system) integrated within an electronic health record (EHR) system in a real world cohort of approximately 12.000 people with diabetes in an outpatient care setting. The main question it aims to answer is: Whether glycemic outcomes following integration of the RPM system into the EHR over a two-year period are non-inferior compared with outcomes observed prior to an ambulatory care restructuring (including a prototype of the RPM-system) in October 2024. Participants are included in the RPM-system as part of their regular medical care for diabetes.

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 recurrent 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.

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.

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.

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.