Clinical Research Directory

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. To evaluate how different video representations of the surgeon-robot relationship influence patients' immediate understanding of who controls the surgical instruments during robot-assisted surgery.

Telemedicine Education Program for Medical Students

This study evaluated a structured telemedicine education program for undergraduate medical students. Third-year medical students participated in either a structured telemedicine education program or a control condition. The education program included theoretical sessions, observation of real telemedicine consultations, simulated patient encounters, and structured feedback. Students' telemedicine knowledge was assessed before and after the study, and their telemedicine consultation skills were evaluated through a standardized simulated patient encounter. The study aimed to examine whether structured telemedicine education could improve medical students' knowledge and consultation skills.

Feasibility and Effectiveness of Tele-diabetes Remote System on Glycemic Control and Quality of Life of Children and Youth With Type 1 Diabetes

The goal of this clinical trial is to examine the feasibility and effectiveness of a tele-diabetes remote monitoring system on managing type 1 diabetes (T1DM) among children and adolescents. The study aims to assess whether this system, which incorporates a WhatsApp-based alert system, can improve clinical outcomes, increase adherence to treatment, enhance quality of life, and reduce healthcare utilization in this population. The main questions it aims to answer are: Does the tele-diabetes remote system improve glycemic control (e.g., time in range \[TIR\], frequency of hypoglycemia and hyperglycemia, HbA1c levels)? Does it enhance adherence to treatment and overall quality of life for children and youth with T1DM? Does the system reduce the number of emergency room visits for diabetic ketoacidosis (DKA) or severe hypoglycemia, hospitalizations, and overall medical costs? Researchers will compare participants who receive WhatsApp notifications (intervention group) with those receiving standard care (control group) to evaluate differences in clinical outcomes, quality of life, and healthcare burden. Participants will: Receive notifications via WhatsApp messages sent by a system developed by the research team, which monitors glucose trends in real-time and sends alerts when patterns (e.g., hypoglycemia, hyperglycemia) are detected. Participate in follow-ups supported by the hybrid medical team between routine clinic visits.

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.

Clinical Time and Temporal Dynamics Study (CLIN-TIME)

TH-CLINICAL-TIME is a prospective, longitudinal observational study evaluating how changes in clinical measurements over time may help researchers better understand patient health trajectories and clinically meaningful outcomes. The study will examine patterns such as changes from an individual's baseline, rate of change, persistence of abnormalities, variability, recurrence, and recovery following clinical events. Data may include routinely collected clinical measurements, physiologic observations, laboratory results, cardiac measurements, imaging-derived measurements, patient-reported information, and remote or digital health data when available and permitted by the study protocol. The study will investigate whether these temporal patterns provide additional information beyond individual measurements taken at a single point in time. The planned study horizon extends from 2026 through 2076, while individual participant follow-up will occur according to the approved study schedule, consent, and applicable requirements.

Pilot Testing of the emPath Platform to Improve Medication for Opioid Use Disorder (MOUD) Linkage and Retention Among Adults With Opioid Use Disorder in Durham, North Carolina

This pilot study will evaluate the emPath digital platform, a platform designed to improve access to and retention in low-barrier telemedicine for delivery of medication for opioid use disorder (MOUD) among adults with opioid use disorder who engage with community outreach programs in Durham, North Carolina.

Health Ahead Comparative Effectiveness Study

The Health Ahead Comparative Effectiveness Study is a pragmatic, parallel-arm interventional platform that systematically compares successive changes to preventive health screening on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each change is isolated as a single variable against current practice, and every comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, so results accumulate on a consistent yardstick across the life of the platform. The first comparison evaluates AI-assisted versus human-only interpretation ("reads") of screening data. Subsequent pre-planned comparisons, added by protocol amendment, evaluate static versus interactive personalized report delivery; mobile community versus fixed laboratory screening; and a hybrid medical-droid-plus-human delivery model versus human-only screening.

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.

The Effectiveness of Telemedicine Monitoring Prehabilitation in Prostate Cancer Patients Undergoing Radical Prostatectomy

The study titled " The effectiveness of telemedicine monitoring prehabilitation in prostate cancer patients undergoing radical prostatectomy " investigates the impact of a structured telemedicine-supported prehabilitation and rehabilitation program on reducing postoperative urinary incontinence in patients with localized prostate cancer. Radical prostatectomy, a common treatment for localized prostate cancer, is often associated with complications such as urinary incontinence, which significantly affects quality of life. This study aims to address this issue by enhancing patients' physical conditioning and adherence to pre- and postoperative rehabilitation through the use of wearable devices and remote physiotherapy consultations.

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.

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.

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.

Integrated Telemedicine Program Evaluation

This project will evaluate a virtual, on-demand telemedicine program for High emergency department (ED) utilizers with comorbid physical health conditions and behavioral health correlates. Researchers will randomize patients to have either full access to the full intervention (treatment group) or to receive only standard care (control group). Analyses will be intent-to-treat. The primary outcome is the number of ED visits 120 days after the first Best Practice Alert (BPA) firing. The research team plans to enroll 3200 patients in this study. However, randomization may end due to system constraints on December 31, 2025 before reaching that target. This sample provides 80% power to detect a 35% relative reduction in ED utilization using a two-tailed test with an alpha of .15, assuming 40% compliance with the program.

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.

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.

Evaluation of the Clinical Impact of Different Telemedicine Practices in Intensive Care Units

The objective of this study is to assess whether an intervention package via telemedicine consisting of daily multidisciplinary rounds with a specialist in intensive care medicine, an intervention package provided by a specialized multiprofessional team (nursing, physical therapy and clinical pharmacy) and a management intervention package, focused on quality and safety, reduces the length of stay in ICU patients in Brazil. Our hypothesis is that the intervention package via telemedicine has the potential to decrease the length of stay in ICU patients in Brazil. The study provides for the implementation of three interventions in association via telemedicine. * Daily multidisciplinary rounds conducted by a physician specialized in intensive care medicine * Intervention package by specialized multidisciplinary team (nursing, physiotherapy and clinical pharmacy). * Management intervention package (quality and safety). The main questions it aims to answer are: * Length of stay in ICU * ICU mortality. * In-hospital mortality. * Ventilator-free days during the first 28 days. * ICU readmission within 48 hours. * Early reintubation (\<48h after elective extubation). * Ventilator-associated events. * Accidental extubation rate. * Patient Mobilization Density. * Adherence to maintaining the head-of-bed elevation. * Adequate prevention of venous thromboembolism. * Rate of patient-days under adequate sedation. * Rate of patients-days with oral or enteral nutrition. * Rate of patients with adequate glycemic control. * Rate of patients-days within normoxemia. * Rate of central venous catheter use. * Central venous catheter dwell time. * Rate of indwelling urinary catheter use. * Indwelling urinary catheter dwell time. * Standard resource use. * Standardized mortality rate.

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.

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.