Clinical Research Directory

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 - each isolated as a single variable against current practice - on the path toward a fully automated screening system deployable in any environment, including the most isolated and resource-limited communities. Each comparison is evaluated with a common set of engagement, behavior-change, experience, cost, and longitudinal outcome measures, allowing results to accumulate on a consistent yardstick across the life of the platform. The first comparison evaluates static versus interactive personalized health report delivery. Subsequent pre-planned comparisons, added by protocol amendment, evaluate mobile community versus fixed laboratory screening; and a hybrid medical-droid plus human-delivery model versus human-only screening. All participants are simultaneously enrolled in the 100-Year Human Aging Study and the Human Observatory Study, contributing individual longitudinal and population-level causal inference data through those protocols.

Depressive Tendency and Counseling Outcomes in Thymoma-Associated MG

This study aimed to examine whether baseline depressive tendency independently predicts post-counseling clinical outcomes in patients with thymoma-associated MG. This single-group pre-post exploratory pilot study enrolled patients with thymoma-associated MG who received eight sessions of Gestalt-oriented psychological counseling. Depressive tendency was defined as a baseline Patient Health Question-naire-9 (PHQ-9) score ≥10. Clinical outcomes, including the Myasthenia Gravis Activities of Daily Living scale (MG-ADL), Myasthenia Gravis Quality of Life 15-item scale (MG-QoL15), and mental BMI (mBMI), were assessed before and after the intervention. Multivariable regression analyses were performed to evaluate whether baseline clinical severity independently predicted post-intervention outcomes after sequential adjustment for baseline scores, age, and sex.

Human Observatory Study

The Human Observatory Study is a prospective observational and ecological surveillance study building a continuously-updating world model for human health, disease, and death at the individual and population level. Individual multi-system clinical data from enrolled participants are linked to a continuously-ingested ecological data infrastructure spanning environmental exposures, social determinants, genealogical and family history records, mortality data, and population health databases at geographic resolutions from home address to global scale and beyond. The resulting model generates individual screening recommendations informed by population-level causal estimates, and population-level causal forecasts anchored by present-timepoint individual clinical biology. Thus creating a feedback architecture designed to improve both simultaneously.

100-Year Human Aging Study

The 100-Year Human Aging Study is a prospective, pragmatic, observational trial enrolling participants across fixed and mobile clinical sites to undergo comprehensive multi-system health screening and longitudinal follow-up until death. Participants are followed to determine whether measurements taken at enrollment and repeated across the lifespan - individually and in combination - predict all-cause mortality, cause-specific mortality, incident serious disease, and functional disability. The study is designed to generate the surrogate endpoint validation data that longevity medicine currently lacks.

Predictive Value of Frailty Scores and Admission Laboratory Markers for Postoperative ICU Mortality

This prospective observational study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS), the Katz Activities of Daily Living (ADL) scale, and admission laboratory markers for postoperative mortality among geriatric patients admitted to the intensive care unit (ICU) after surgery. Frailty assessment and functional status are increasingly recognized as determinants of outcomes in older adults, yet their combined predictive power with routine laboratory parameters at ICU admission remains unclear. By systematically collecting clinical scores and laboratory data at the time of ICU admission, this study seeks to identify early predictors of mortality and support risk-stratification in geriatric postoperative patients.

Virtual Activities of Living for Occupational Rehabilitation

Duke University will serve as the clinical research site for the Phase II RCT of the VALOR system, which enables telehealth delivery of evidence-based upper extremity (UE) stroke therapy in a patient's home using immersive VR headset technology for guided practice of activities of daily living (ADLs) and instrumental ADLs (IADLs). The study compares VALOR Home Exercise Program (HEP) to Usual Care Treatment (UCT) in adults with stroke-related UE impairment.

The Impact of Training on Self-Efficacy, Symptom Level, and Activities of Daily Living

This study is a randomized, controlled experimental trial with a pretest-posttest design, conducted to evaluate the effects of Pecha Kucha-based education on self-efficacy, symptom level, and activities of daily living in individuals diagnosed with chronic obstructive pulmonary disease (COPD) receiving noninvasive mechanical ventilation support. The study will include two groups, and intergroup differences will be evaluated: 1. Control group 2. Intervention group Study Hypotheses H1: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) increases patients' self-efficacy levels. H2: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) reduces patients' symptom levels. H3: Pecha Kucha-based education on noninvasive mechanical ventilation (NIMV) support provided to individuals with chronic obstructive pulmonary disease (COPD) improves patients' activities of daily living.

Effectiveness of Online Program and Task-related Training for Parkinson's Disease

The goal of this clinical trial is to compare the effectiveness of online self-management program and on-site task-related training for people with early stage Parkinson's disease. people with early stage of Parkinson's disease (age range: 45-70 years) will be randomly assigned into the following three groups: control group, online self-management program group and on-site task-related training group.The control group will receive no treatment during the experimental period. For the other two groups, participants will receive the intervention twice a week, one hour per session and 12 sessions in total. The main questions it aims to answer are: 1. the potential impact of motor and non-motor symptoms on activity participation and quality of life for people with early stage of Parkinson's disease (PD). 2. compare and examine the the effectiveness of online self-management program and on-site task-related training for people with early stage Parkinson's disease on activity participation and quality of life.

The Effects of a Dynamic Arm Support in Daily Life

The goal of this mixed method study is to learn about how a dynamic arm support device (DAS) helps people with everyday activities. The study focuses on people with neuro(-muscular) conditions, age 16 and older. The research questions that are formulated, are: * How does a person experience their daily activities, with and without a DAS? * What are the contextual (external and personal) factors that influence the use of a DAS? Participants will take part in three testing sessions. In each session, they must complete a few questionnaires and participate in an interview. The first time, without DAS. In the second and third session, they will be using their DAS (resp. 3 to 4 weeks and 3 months). The data collection will be executed by phone, digital questionnaires and/or paper.

Geriatric Oncology Care in Brazil: Remote Geriatric Assessment-Driven Interventions With Supportive Care

The goal of this clinical trial is to determine whether a telehealth-delivered, geriatric assessment-guided supportive care program (GAIN-S) can improve health outcomes in older adults (age 65 and above) with solid tumors who are starting a new cancer treatment in Brazil. The main questions it aims to answer are: * Does GAIN-S improve physical function, as measured by activities of daily living (ADL), after three months? * Does GAIN-S reduce symptoms of depression and improve quality of life after three months? Researchers will compare patients receiving the GAIN-S intervention to those receiving standard care to see if the intervention leads to better physical function, fewer symptoms of depression, and improved quality of life. Participants will: * Complete a geriatric assessment (CARG-GA) before and after treatment. * Be randomized to either standard care or the GAIN-S intervention. * If assigned to GAIN-S, receive tailored supportive care via telehealth, which may include consultations with a psychologist, psychiatrist, nutritionist, geriatrician, exercise physiologist, or other specialists based on their needs.

Virtual Senior Center

In a 3-group trial with randomization and follow-up for 12 months, we will compare use of the VSC as well as health and quality of life outcomes among 650 older adults in St. Louis who receive either: (1) home delivered meals AND a GrandPad; (2) home-delivered meals but no GrandPad for 6 months; and (3) in person meals at senior center but no GrandPad.

Assessment of Overall Functioning in Patients With Complex Health Issues

The overall aim of the study is to assess whether each outcome measures the same aspect of overall functioning or contributes with different aspects. More specifically, the aim of this study is to investigate the correlation between each single instrument. During study period all patients presenting at our clinic will be offered to participate in the study. Patients will be included in the study when referred to the department of Social Medicine and providing written informed consent to participate in the study. Inclusion will continue until 100 patients have completed an AMPS test. All participants will, apart from standard procedure, be asked to complete: * An AMPS-test * ADL-Q (Questionnaire concerning Activities of Daily Living) * ADL-I (Interview based questionnaire concerning Activites of Daily Living) As standard procedure all participants will also perform/complete: * 30 seconds chair stand test (30sCST) * Hand grip strength (HGS) * Evaluation of ambulation (Cumulated Ambulation Score /CAS) * WORQ (Work Rehabilitation Questionnaire) To obtain the aim of the study correlation-analysis will be performed to investigate the relationship between each included instruments.

Digital Solutions for Elderly Care by Informal Caregivers

The study aims to determine the benefits of a web-based documentation and advice for elderly people and their caregivers. It is a randomized controlled trial with two arms (intervention, control). While the participants will be supported by a web-based application within the intervention, they will receive standard care only in the control. In addition, a follow-up until the end of the study will be realized.