Clinical Research Directory

Integrating Telehealth to Advance Lung Cancer Screening

The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are: 1. Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS? 2. Is the effectiveness of these telehealth strategies similar by race and sex? The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.

REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices

Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs. However, not all patients with a heart pump are able to attend to a supervised program on a daily basis. The goal of this clinical trial is to determine whether a home-based exercise program helps patients with a heart pump improve their exercise capacity and quality of life, guided by telemedicine tools including a mobile app, smartwatch, and remote medical checkups. The study will also provide information about the safety of this program by monitoring for any issues or symptoms during home activity. The trial aims to answer the following questions: * Does a 12-week remote exercise program improve patients' exercise capacity? This will be measured using the 6-minute walk test and a cardiopulmonary exercise test. * Is it safe for patients to follow this exercise plan at home while being monitored through a mobile app and smartwatch? * Does the program improve quality of life and reduce feelings of anxiety or depression? This will be assessed using widely validated questionnaires, such as the Kansas City Cardiomyopathy Questionnaire. Researchers will compare the remote exercise program to standard care, which usually does not include exercise for patients who are unable to attend the hospital daily. Participants will: * Join the study voluntarily after signing a consent form. * Be randomly assigned, with a 50% chance of being in either the exercise group (following a structured plan with a mobile app) or the usual care group (receiving general written advice), to see which approach works best for recovery. * Follow a 12-week home-based routine if in the exercise group, including warm-up routine, walking or cycling, respiratory exercises, and light strength training, all supported by the mobile app, smartwatch, and professional monitoring. * Visit the hospital three times over six months for medical checkups, including walking and exercise tests, blood analyses, and questionnaires about physical and emotional health.

ANCHOR Validation Trial in High-Risk Multidisciplinary Care

This pre-registered, pragmatic, three-arm (1:1:1) patient-level randomized controlled trial with mixed-effects analysis at the encounter level tests two questions in real high-risk multidisciplinary clinical encounters at the Waymark clinically integrated network across three U.S. states (Ohio, Washington, Virginia): (1) does adding ANCHOR - a clinical AI structural verification layer - to a Gemini 3.1 Pro-assisted supervising-physician workflow reduce the rate of clinically meaningful safety failures, compared with the same Gemini 3.1 Pro-assisted workflow without ANCHOR? (2) does the Gemini 3.1 Pro-assisted workflow itself reduce the same safety endpoint compared with unassisted standard care in which the supervising physician writes their own SOAP assessment/plan from a blank template? ANCHOR is a single-call structural verification layer combining a Logical Neural Network (Riegel et al. 2020) certificate, six specialist agents, and concept-decomposed output with PMID citation provenance. ANCHOR is physician-facing only and is used by supervising physicians, not by the multidisciplinary clinical team they oversee. The trial randomizes 240 patients 1:1:1 across the Waymark clinically integrated network over a 12-week active-enrolment window (80 per arm). Eligible patients are adults (age 18+) identified as high-risk by combined claims-based and clinical criteria. Eligible encounters span three integrated Waymark service modalities: high-risk primary care, specialty care coordination, and real-time telemedicine urgent care. The primary endpoint is a per-encounter binary composite: any of (a) failure to mention a do-not-miss diagnosis, (b) under-triage, (c) contraindicated medication recommendation, (d) failure to recommend escalation when clinically warranted; adjudicated by a blinded panel of 3 board-certified physicians with majority-of-three scoring. The primary contrast is Arm 3 (LLM+ANCHOR) versus Arm 2 (LLM with safety prompt), isolating ANCHOR's marginal contribution over a deployment-equivalent LLM safety stack. The pre-specified secondary contrast is Arm 2 versus Arm 1. The trial is sized to the operational ceiling of the Waymark integrated-network workflow across the three states (240 enrollees over 12 weeks). At realistic effect sizes derived from the retrospective evaluation, the trial is underpowered for definitive efficacy declaration on either pairwise contrast and is reported as an initial deployment-feasibility validation cohort with effect estimates and 95 percent confidence intervals; full power calculations are pre-registered in the Statistical Analysis Plan. Single-blind outcome adjudication: 3 adjudicators score only the supervising physician's final clinical decision, so all three arms produce adjudication packets in identical format and arm allocation is structurally invisible. Statisticians remain blinded until database lock. A full waiver of informed consent is requested per 45 CFR 46.116(f)(3) with a companion HIPAA waiver of authorization under 45 CFR 164.512(i)(2)(ii). The study is registered on the Open Science Framework prior to first enrollment and reported under CONSORT-AI 2020.

Remote Programming of Cardiac Implantable Electronic Device

Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full interrogation and changing the CIED parameters is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. We aim to investigate the efficacy and safety of remote programming.

Telemedicine-Based Emergency Physician Assessment Prior to ED Entry: A Randomized Controlled Trial

Background: Emergency department (ED) overcrowding is a growing challenge worldwide and is associated with prolonged length of stay (LOS), reduced patient satisfaction, and increased burden on healthcare systems. New approaches are needed to improve how patients are evaluated and treated. Telemedicine has been increasingly integrated into ED care and has shown feasibility and benefits in various settings. Existing models have demonstrated improvements in patient flow, reduced length of stay, and high patient satisfaction. However, despite the growing use of telemedicine in emergency medicine, there is a lack of randomized controlled trials evaluating its effectiveness and safety, particularly in models involving early remote physician assessment prior to ED evaluation. Purpose: This study aims to evaluate whether a video consultation with a senior emergency physician before entering the ED can improve the efficiency and quality of care. The study also examines whether physicians can accurately identify which patients need ED evaluation based on a remote assessment, while maintaining patient safety. Methods: A total of 200 adults who arrived at the ED were assigned to one of two groups. In the study group, participants had a video consultation with a physician before continuing with standard ED care. In the control group, participants received standard ED care only. During the video consultation, the physician performed an initial clinical assessment and could order tests or specialist consultations. The physician was also asked what their recommendation would have been if the participant had been assessed from home. Three possible decisions were recorded: * Immediate ED presentation * Scheduled ED presentation at a later time * Continued care in the community without ED presentation Outcomes: The primary outcomes focus on the effectiveness of the intervention. These include: * ED length of stay * Patient satisfaction * The ability of physicians to accurately identify participants who require ED evaluation The secondary outcome is safety, assessed by return visits to the ED within one week for the same complaint.

The Risk of Surgical Cancellation in Adult Patients Assessed by Telephone Versus In-person for Scheduled Non-cardiac Elective Surgery.

Telemedicine has been regulated in Colombia since 2006, with applications in anesthesia being explored since 2004 to improve accessibility and reduce costs. Although Decree 538 of 2020 expanded telemedicine's medical applications, challenges such as connectivity issues and training needs remain. Telemedicine has shown promise in rural areas of Colombia, particularly for managing chronic diseases. However, further evidence is needed regarding the effectiveness of telephone pre-anesthetic evaluations. This study aims to investigate the implementation of telephone assessments for non-cardiac surgery and their impact on surgical cancellations compared to in-person pre-anesthetic evaluations. The primary question to answer is: ¿Does telephone pre-anesthetic assessment in non-cardiac surgical patients carry a higher risk of surgical cancellations compared to in-person evaluations? To address this question, investigators will evaluate patients' medical records in two hospitals where patients were assessed using both telephone and in-person modalities.

Pre-anesthetic Teleconsultations During Pregnancy

Quality of teleconsultation in comparison to face-to-face consultation for pre anesthetic evaluation in pregnant persons before delivery will be evaluated. Quality is evaluated with a composite criterion comprising 7 elements required for security of anesthesia. Discordance between this composite criterion during the pre anesthesia visit the day of delivery and pre anesthesia consultation several weeks before delivery will be assessed.

Evaluation of Dora Care for Supporting Fracture Liaison Services (FLS)

What is the study about? This study is testing "Dora", an AI-powered assistant that can make phone calls to patients, for use in the Fracture Liaison Service (FLS). The FLS is a clinic that helps prevent more bone fractures after an initial "fragility fracture" (a break that happens easily, usually due to osteoporosis). Why is this being done? FLS clinicians often have to spend a lot of time on routine phone calls for assessments and follow-ups. If Dora can safely and accurately collect patient information, it might save time for staff and still give patients a good experience. What will happen to patients in the study? Invitation and consent - Patients with a new fragility fracture who are eligible will be invited to take part after informed consent. Dora call - Patients will receive an automated phone call from Dora, at the start of their FLS pathway and at follow-up. At intake, Dora will ask about risk factors for bone problems (e.g., smoking, alcohol use, family fracture history). At follow-up, Dora will ask about medication use, side effects, falls, or new fractures. Clinician call - Soon after, patients will have their usual phone appointment with an FLS clinician, who asks similar questions. Surveys/interviews - Patients will be asked to complete a short questionnaire and take part in an optional interview to say how they felt about talking to Dora. What about clinicians? Clinicians involved in the FLS pathway will be asked to complete a short survey and to take part in an optional interview to understand how useful Dora's reports might be in their work. Who can take part? Patients - Age 50+, English-speaking, with a new fragility fracture, and able to use the phone. Clinicians - Those working in FLS or similar bone health services. How long will it take? Each patient might be involved for up to about 7 months. The whole study will take about a year.

Mindfulness Meditation for Insomnia

The investigators will conduct a 3-arm, pilot RCT where participants (N=30) will be randomized in a 1:1:1 design to 4 weeks of instructed bedtime MM practice at night (n=10) vs. uninstructed MM (n=10) vs. sleep hygiene education only (n=10). Aim 1 is to understand the feasibility and acceptability of the intervention and study procedures. Aim 2 is to explore patterns of within-group changes in sleep outcomes (i.e., insomnia severity and sleep quality). Patient-reported outcomes will be collected using a HIPAA-compliant electronic data management system (REDCap). Following informed consent, participants will receive links to REDCap surveys via email at Weeks 0, 4, 8, and 16. The investigators will also conduct a post-intervention interview at the end of Week 4 and an exit interview at Week 16. All participants will also receive a research kit with wearable devices and meet with our staff after they receive the kit for instructions. Data collected in the pilot RCT will help us to preliminarily identify tools for subjective measures and physiological signals to inform a future trial.

Virtual Ward for Early Discharge in Patients Receiving Inpatient Care

This study evaluates the feasibility of providing hospital-level care at home for eligible patients through a Virtual Ward. Patients are discharged early from the hospital and monitored remotely using digital vital sign monitoring and anamnesis questionnaires. The primary aim is to determine if at least 30% of eligible patients can be safely and successfully transferred to the Virtual Ward under current Dutch healthcare conditions.

TeleMAb Retrospective Cohort Study

The objective of this study is to evaluate whether there are different clinical outcomes and unscheduled follow-ups between in-person and telemedicine medication abortion, and to better understand patients' experiences with telemedicine medication abortion and their motivations for seeking unscheduled follow-up care in a setting where abortion care, including both virtual and in-person follow-up care, is readily accessible.

Sleep for Stroke Management and Recovery Trial

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Public Perceptions Toward Robotic Surgery, Telesurgery and Telemedicine

This study aims to systematically assess the public's and clinicians' levels of awareness, attitudes, risk perception, acceptance, and potential concerns regarding robotic surgery and telesurgery. It also analyzes the key factors influencing their attitudes and explores the needs of physicians regarding training systems for robotic and telesurgery, as well as the factors affecting their preparedness.

Proactive Telemedicine to Improve Healthcare Access and Prevention in Rural Primary Care (PTM)

The study evaluates whether Proactive Telemedicine (PTM) can improve healthcare access for individuals who have not contacted their primary care team for at least one year, compared with face-to-face visits. PTM consists of brief, remote behavioral interventions addressing modifiable risk factors such as tobacco use, alcohol consumption (AUDIT-C: Alcohol Use Disorders Identification Test - Consumption), physical activity (IPAQ: International Physical Activity Questionnaire), and Mediterranean diet adherence (PREDIMED: Prevención con Dieta Mediterránea). PTM follows national preventive protocols including PAPPS (Programa de Actividades Preventivas y de Promoción de la Salud) and uses validated tools such as EuroQol-5D-5L (EQ-5D-5L) to measure healthcare accessibility and quality-of-life outcomes. This randomized non-inferiority trial aims to determine whether PTM is as effective and safe as traditional in-person consultations.

Smoking Cessation Program for the Older Smokers

This study aims to assess the effect of mobile health (mHealth) support or financial incentives and their interactive intervention effect on smoking cessation (SC) in old smokers in Hong Kong (HK).

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.

Effect of Visual Feedback From the SpiroGym Mobile Application

The previous pilot study showed that two weeks of intensive expiratory muscle strength training (EMST) with SpiroGym was sufficient to significantly improve voluntary peak cough flow (PCF). The improvement was quantitatively comparable to that reported in other intensive EMST studies of longer duration. To explain this rapid improvement, we considered the potential contribution of SpiroGym's visual feedback. We assumed that real-time visual feedback increased training effort compared with conventional EMST performed without immediate feedback. The aim of this study is to evaluate the effect of visual feedback provided by the SpiroGym mobile application on performance during expiratory muscle strength training in patients with Parkinson's disease.

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.

Development and Testing of a Mobile Health Application for Management of Gestational Diabetes

Adequate control and management of gestational diabetes mellitus (GDM) during pregnancy is critical to mitigate its short- and long-term health consequences in women and their children and may serve as a key strategy to curb the escalating type 2 diabetes epidemic in low- and middle-income countries (LMICs). Taking a user-centered design approach, here the study investigators propose to develop a culturally-appropriate smartphone application (app) to support self-management of GDM, and additionally, test its usability and preliminary efficacy, among patients in a peri-urban hospital setting in Nepal. App-based lifestyle interventions for GDM management are not common, especially in LMICs where its prevalence is rapidly increasing, and as such, study findings will have important public health relevance for a broader population.

Just-In-Time Adaptive Interventions for Diabetic Patients

The addition of proactive nurse consultations was useful to older adults with diabetes mellitus in facilitating their chronic disease self-management. However, the service is time and resource-intensive. With the support of advanced technology, mhealth App seems to be a convenient way to support patients in managing diabetes.

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"\[Mesh\] )

Assessment of Remote Vital Signs for Telemedicine Applications

The purpose of this study is to determine whether vital signs can be extracted from video. A secondary purpose is to create a database, including raw video, of "ground truth" physiological data on human subjects in order to test current and/or future approaches developed to extract vital signs from video. This research may have an immediate impact on not only the assessment of risk for COVID-19 but also may provide a significant technological enhancement to Johns Hopkins Medicine's telemedicine capabilities.

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.

The Actuate-CBC Study

The study team will use implementation science to accelerate the uptake of teleconsultationfor burn patients by 1) examining the relationships between clinician perceptions of acceptability, feasibility, intention to use, and actual use of burn teleconsultation 2) identifying the optimal process for burn teleconsultation and the barriers and facilitators for its use during a crisis or prolonged care situation, and 3) designing and testing the effectiveness of a specific, tailored burn teleconsultation toolkit intervention to increase burn teleconsultation use.