Clinical Research Directory

Expanded Population Health Model Evaluation

This study will evaluate the impact of a comprehensive wellness and social determinants of health intervention on cardiovascular health in a community setting of the Bonton neighborhood. Participants will not be assigned to intervention activities, but health and wellbeing indicators will be collected in relation to how they choose to participate in activities over the year.

Implementation Facilitation of Exercise is Medicine Greenville

A public health priority exists for the U.S. healthcare sector to integrate physical activity (PA) as a part of the patient care model. This research will provide valuable information on facilitating optimal implementation of a clinic-to-community model that identifies, refers, and enrolls physically inactive patients to community-based PA programs for the prevention and treatment of chronic diseases. Further, this work will provide evidence on the cost-effectiveness of integrating PA in healthcare systems as a population health management strategy.

Identification of Vocal Biomarkers to Monitor the Health of People With a Chronic Disease

The CoLive Voice research project aims to identify vocal biomarkers of severe conditions and frequent health symptoms. The project is based on digital technologies and statistical algorithms. This is an international anonymous survey where vocal recordings are collected simultaneously with large validated clinical and epidemiological data, in the context of various chronic diseases or frequent health symptoms in the general population.

Sustainability of the Effects of an Adapted Physical Activity Program on Physical Fitness and Psycho-behavioral Factors in Patients With Chronic Diseases

This study aims to determine the extent to which different approaches to adapted physical activity coaching influence physical fitness, psycho-behavioral, and anthropometric parameters in patients with stabilized chronic conditions who have been referred to a Sport-Health Center by their physician. The trial includes four parallel groups, distinguishing between two program durations (3 months or 6 months) and the use or non-use of a smartwatch as a tool for monitoring activity. All participants complete 24 sessions of adapted physical activity (APA), in accordance with the standard practices of the La Musse Sport-Health Center, where the study is entirely conducted. However, the distribution of sessions differs by group: two sessions per week over three months or one session per week over six months. Randomization is stratified by age, sex, and baseline fitness level. Assessments are conducted at the following five time points: enrollment (T0), end of the 3-month program (T1), end of the 6-month program (T2), followed by follow-up at 12 months (T3) and 18 months (T4), to observe the durability of the effects after the supervised phase. The primary outcome measure is improvement in physical fitness and anthropometric parameters, objectively measured using tests recognized for their reliability (TDM6, Sit-to-Stand 30s, Timed Up and Go, Sit and Reach, grip strength, BMI, waist circumference). The secondary outcomes focus on changes in motivation toward health-related physical activity (EMAPS), perceived self-efficacy to engage in physical activity (ECS), and self-reported physical activity (IPAQ-SF), which will be collected regularly throughout the program, more frequently than in standard care. A total of 280 patients will be enrolled to ensure sufficient statistical power, taking into account an anticipated loss-to-follow-up rate over 18 months. Data collection and processing will be pseudonymized and conducted on the secure network of La Musse Hospital.

Chronic Diseases in Primary Care

This quasi-experimental study aims to assess if a nurse-led proactive intervention can enhance self-care and reduce hospitalizations or accesses to emergency department visits in chronically ill adults over 65 years old. The questions that it seeks to answer are the following: 1. Can a structured, proactive nurse-led intervention reduce hospitalizations and access to emergency departments? 2. Can this intervention improve self-care, medication adherence, and the overall quality of life? To assess its effectiveness, researchers will evaluate health outcomes before and after carrying out the intervention. Participants will receive an initial assessment to identify specific educational needs. To enhance self-care and symptom management, patients will participate in at least three scheduled follow-up sessions (via phone call or face-to-face) during the following six months. They will also complete questionnaires assessing lifestyle quality, medication adherence, and self-care abilities.

A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions

Among people who do not want to get pregnant, some do not use any birth control. This is also called contraceptive nonuse. Common reasons for contraceptive nonuse include concerns about birth control safety or side effects. People with health conditions, such as diabetes or high blood pressure, also report worries about how different birth control methods might affect their health condition or medicines. The goal of this clinical trial is to learn if a web tool called My Health, My Choice helps people with health conditions understand their birth control options and choose birth control that is right for them. The study will also look at the medical safety of birth control methods that participants decide to use. The main questions it aims to answer are: • Does the My Health My Choice tool lower the number of participants who do not use any birth control method? (contraceptive nonuse) In other words, does the My Health My Choice tool increase the number of participants who use any birth control method? (contraceptive use) Participants who use the My Health, My Choice tool before a clinic visit with their clinician (Intervention Group) will be compared to participants who only go to a clinic visit with their clinician (Usual Care Group). For this study, a "clinician" is any licensed health care provider who counsels about birth control, prescribes birth control, and/or inserts birth control devices. All participants will: * Complete 4-5 online surveys that take 5-10 minutes each, over a 3 month time period * Be asked to go to a scheduled clinic visit with their health care provider * A small group of participants (about 30) will be invited to a 1 hour exit interview Participants in the intervention arm will be asked to: • Use the My Health My Choice tool before their clinic visit

CHIME: Comparing Health Interventions for Maternal Equity

The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum. The main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum. Hypothesis (primary): Both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group. Hypothesis (secondary): The community-based intervention will have greater effectiveness than the self-management intervention. Participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. General procedures include completion of: * Questionnaires * Dietary recalls * In-depth interviews * Anthropometric measurements * Collection of blood via finger stick or blood panel

Families Implementing Good Health Traditions for Life

This study will provide evidence for the utility of using a community-engaged research approach to implement a tailored, family-oriented adaptation of the Diabetes Prevention Program that will have positive effects on risk factors associated with type 2 diabetes morbidity and mortality among Black families in a Southwest Georgia community.

Click & Pick Study

Unhealthy diets significantly contribute to major preventable chronic diseases including type 2 diabetes, obesity, heart disease and stroke, which disproportionally impact racial/ethnic minority groups and those with lower income \[1-3\]. Although taxes and warning labels targeting sugar-sweetened beverages (SSB) have been successful at shifting behavior \[4-7\], there are many other ultra-processed food products that contribute to unhealthy diets \[8\]. What is less well-known is whether a suite of healthy food policies that are expanded to target a range of ultra-processed foods can shift dietary choices and intake in meaningful ways. Our research team's long-term goal is to identify and understand the degree to which combinations of healthy food policies can improve nutrition security and reduce nutrition-related diseases.

Pursuing the Triple Aim in Hotspotters: Identification and Integrated Care

Hotspotters are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. Reliable data on (cost-)effective interventions for these patients are scarce. The goal of this study is to assess the cost-effectiveness of pro-active and integrated care. This approach includes: an intake consultation with Positive Health; multidisciplinary meetings with physician, mental healthcare nurse, social worker and the patient; a personalised care plan and proactive care management. We aim to include 200 patients, divided over 20 primary care practices.

Determinants of Medication Non-Adherence Among Patients With Chronic Diseases in Egyptian Community Pharmacies

Medication non-adherence among patients with chronic diseases is a major public health concern and is associated with poor disease control, increased complications, and higher healthcare costs. Community pharmacists play an important role in supporting patients' medication use through counseling and education; however, the determinants of medication non-adherence among patients attending community pharmacies in Egypt are not well characterized. This multicenter, cross-sectional study aims to assess the prevalence of medication non-adherence and identify factors associated with non-adherence among adult Egyptian patients with chronic diseases attending community pharmacy settings. Medication adherence will be evaluated using the Adherence in Chronic Diseases Scale (ACDS), along with sociodemographic, clinical, and medication-related factors. The findings are expected to provide evidence to inform strategies for improving medication adherence and optimizing chronic disease management in community pharmacy practice in Egypt.

Integrating Vaccination Into Hospital Care Pathways for Vulnerable Patients

AMBU-VAX is a prospective, single-center observational study designed to develop and implement an organizational model for delivering recommended vaccinations within a hospital setting. The study targets adult and elderly patients with chronic diseases or immunocompromising conditions who are eligible for vaccination according to national immunization guidelines. Vaccination is actively proposed during outpatient visits, hospital admissions, or at discharge and, when accepted, administered within the hospital or coordinated with local public health vaccination services. The study aims to evaluate the feasibility, uptake, and completion of hospital-based vaccination pathways and to support integration between hospital and territorial prevention services for vulnerable populations.

The MURDOCK Study Registry and Biorepository Horizon 1.5

The MURDOCK Study Community Registry and Biorepository (Horizon 1.5) aims to create a large-scale community registry and biorepository that can be used as a vehicle for future health services, epidemiologic, clinical trials and other omics-related research.

Identification of Patients With Advanced Chronic Diseases in Need of Palliative Care

Patients with advanced chronic diseases often have complex health needs and may benefit from palliative care. However, many of these patients are not identified early enough to receive appropriate palliative care interventions. This prospective observational study aims to identify hospitalized patients and patients attending a day hospital with advanced chronic conditions who have palliative care needs, using the NECPAL tool. NECPAL is a validated screening instrument designed to identify patients with advanced chronic diseases who may benefit from palliative care, based on clinical indicators, disease progression, functional decline, and health care utilization. Adult patients with advanced oncological and non-oncological chronic diseases will be consecutively evaluated. The NECPAL tool will be applied by trained investigators as part of routine clinical assessment. Patients will be classified as NECPAL positive or NECPAL negative according to predefined criteria. The study will estimate the proportion of patients identified as NECPAL positive, describe their clinical characteristics, and analyze whether they are receiving palliative care. Secondary objectives include comparing clinical variables, comorbidity indices, and mortality between NECPAL-positive and NECPAL-negative patients over follow-up. The results of this study will provide information on the prevalence of palliative care needs among patients with advanced chronic diseases and support early identification strategies in hospital settings.

Evaluation of AI Cost Prediction Model to Enroll Patients in Complex Care Management Program

Currently, UCLA Health (specifically the Office of Population Health and Accountable Care, or OPHAC) runs a complex care management program called Proactive Care (goal is to reduce care utilization by providing personalized care navigation/case management). Every month, an AI Population Risk tool runs to identify around 250 of the 480,000 or so UCLA primary care patients, and RNs contact these 250 patients to enroll in Proactive Care. Starting in December 2024, OPHAC launched a new method of enrolling UCLA's Medicare Advantage (MA) patients into Proactive Care: an AI Cost Prediction model. The idea is the same-- the top 250 highest predicted cost patients will be enrolled in Proactive Care. The investigators will evaluate this model and subsequent enrollment into the program by randomizing the waitlist of MA patients waiting to enroll in Proactive Care, thereby creating a control group. The top 500 highest predicted cost patients will be identified each month, and following a 1:1 randomization, 250 will be contacted for enrollment and the rest will be put on a wait-list control group for 10 months unless otherwise requested by their provider to be enrolled in the Proactive Care program earlier.

Testing the Feasibility of a Self-Management Support Program for Patient With Chronic Diseases in Israel

This study explores an intervention to support people in Israel who are living with chronic health conditions such as cancer or after kidney transplantation. It focuses on a well-known international program called the Chronic Disease Self-Management Program (CDSMP), which was developed at Stanford University. The program helps individuals build confidence and skills to better manage their health, feel more in control, and improve their day-to-day quality of life. Participants will take part in a six-week group program, delivered online, where they will learn practical strategies for managing symptoms like fatigue or pain, setting achievable health goals, communicating effectively with healthcare professionals, and staying active and engaged. The sessions are guided by trained facilitators and include support from others facing similar health challenges. The study will involve surveys before and after the program, as well as a follow-up six months later, to understand how the program may have helped participants. Some participants will also be invited to share their experiences in small discussion groups. By testing this program in Israel, the researchers hope to learn how it can be adapted and offered more widely to help others living with chronic conditions.

Moxie Self-Management and Education Support Program

Health education and self-management support are key facilitators of health behaviours. Moxie is a mixed media, self-management, education and support program for Albertans living with cardiovascular-related chronic conditions. Moxie is built upon our previous work within the ACCESS study (2015-21, n=4761), a RCT that previously tested the Moxie intervention in Alberta. Results demonstrated that MOXIE reduced the rate of hospitalizations (notably for hypertension, angina, hyper/hypoglycemia, heart failure decompensation, and acute kidney complications) by 34% in a population of low-income seniors living with cardiovascular-related chronic conditions. However, before Moxie can be effectively implemented province-wide, another trial is necessary to determine whether benefits can be observed in a larger cohort of patients with cardiovascular-related chronic conditions recruited immediately after hospital discharge (n=9000). Furthermore, the effectiveness of the two components of the ACCESS trial intervention will be assessed individually: (a) The Moxie Program, a tailored health and disease education component developed by a user-experience-centric design process incorporating patients, behavioural scientists, disease specialists, health system administrators and marketing/advertising professionals; and (b) the facilitated relay of clinical information to healthcare providers (letters). The trial is designed as a 2x2 factorial pragmatic, individual-level randomized pragmatic trial of these different interventions. This would yield the following groups: 1. Moxie SMES Program 2. Facilitated Relay 3. Moxie SMES Program and Facilitated Relay 4. True control Self-management education and support (SMES) intervention: This includes weekly physical mailers sent directly to patients' homes throughout the study containing information about chronic conditions, medication use, diet, physical activity, smoking cessation, and self-management/wellness principles. These messages will be refined by the social impact creative design partner and reviewed by clinicians and patients to ensure clinical safety and appropriate tone. Weekly mailers will encourage participants to enroll and consent to participate in the digital program by scanning a QR code or accessing a website where they will sign up for their own personalized Moxie mobile health app, complete a digital consent form and opt-in for electronic delivery of Moxie messages. Facilitated relay intervention: Participants allocated to this intervention will receive letters by mail, one addressed to them, one to their primary care provider, and one to their pharmacist. The letters will not be sent to their primary care provider directly; rather, they will be sent to patients who will be encouraged to take them to their primary care provider and pharmacist should they decide to do so. We hope this will empower patients to start discussions with their healthcare providers. This also supports patient autonomy by enabling patients to decide whether they want to take them to their provider or not. If for whatever reason they do not feel that this is going to be beneficial or of interest, they are not required to do so. The letter would contain a note to the patient's healthcare provider stating that their patient is at-risk of cardiovascular disease and that evidence has shown that the pharmacotherapy is effective in improving outcomes for patients similar to the participant. The primary outcome is readmission for cardiovascular-specific ambulatory care-sensitive conditions (ACSC) based on the most responsible diagnosis listed in CIHI Discharge Abstract Database-(DAD), using established algorithms within 12 months from randomization. This outcome includes all repeat admissions in the study period as recorded in the health record. This outcome is a count variable. We will calculate and compare each intervention arm's mean number and distribution of hospitalizations.

Chronic Wounds and Blood Circulation Detection

Lower limb circulatory insufficiency and the associated chronic wounds are common health problems among the elderly. These issues not only affect the individual's mobility and quality of life but also potentially increase medical costs and caregiving expenses. Traditional treatment methods often employ medications to enhance blood circulation, but these clinical approaches have limited effectiveness and induce the risk of side effects. Utilizing exercise as an intervention strategy can help improve lower limb blood circulation in the elderly while reducing the side effects associated with medications. However, due to physical frailty, elderly individuals often cannot participate in high-intensity exercises to improve their circulatory performance. Therefore, this study will develop a lower limb circulation enhancement exercise system to improve the circulatory performance in individuals with poor lower limb circulation. It will compare the effects of lower limb circulation enhancement exercise, vibration exercise, and mixed exercise on improving blood circulation and functional performance in the elderly or individuals with poor lower limb circulation. Participants will be randomly assigned into three groups: the lower limb circulation enhancement exercise group, the vibration exercise group, and the mixed exercise group. In addition, a separate group of young adults (control group) will serve as a reference for baseline comparisons. Initially, all participants will undergo a one-time exercise test, followed by a 12-week intervention. The lower limb circulation enhancement exercise group will perform a 30-minute leg press rowing exercise three times a week, while the vibration exercise group will engage in vibration exercise at the same frequency, and the mixed exercise group will perform group-based mixed exercise training at the same frequency. The young adult control group will not receive any intervention but will undergo the same assessments. Outcome evaluations before and after the intervention include lower limb blood perfusion monitoring, pain scales, and functional performance assessments.

TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejection: Correlation With Response to Extracorporeal Photo-aphereSiS

With this project, the research team aims to identify the molecular pathways associated with the response to extracorporeal photonchemioapheresis (ECP) in kidney or lung transplant patients suffering from chronic rejection, by analyzing gene expression in samples of peripheral blood mononuclear cells.

Taining Golden Lake Comprehensive Chronic Disease Management Initiative

This study aims to establish the first county-level, population-based prospective cohort in Taining County, Fujian Province, China. The cohort will include at least 20,000 residents aged 18 years or older. The project will systematically collect questionnaires, physical measurements, laboratory tests, imaging data, and biological samples to build a multi-dimensional health database and biobank. Through 3-year follow-up, the study seeks to reveal the epidemiological patterns and risk factors of chronic diseases, characterize the natural course of multimorbidity and aging syndromes, and develop a comprehensive chronic disease management model suitable for rural and mountainous regions.

Effects of the Clinical Application of Traditional, Complementary and Integrative Medicine (TCIM) Procedures During Inpatient Stays in Germany

The aim of this healthcare research project is to evaluate the effects of routine inpatient TCIM (Traditional, Complementary and Integrative Medicine) care in Germany. The focus is on the TCIM centers at Immanuel Krankenhaus Berlin, Klinikum Bamberg und Evang. Kliniken Essen-Mitte, where inpatient TCIM therapies are to be systematically evaluated. This form of therapy, which is reimbursed by statutory health insurance providers (under certain conditions), is based on a combination of various evidence-based TCIM approaches. These include hyperthermia, exercise therapy, Mind-Body Medicine, phytotherapy, nutritional therapy, fasting therapy inter alia.

Impact of an Intervention Integrating the MPHS Nursing Model of Care on the Partnership in Health, With the Patient Followed in Primary Care by an Advanced Practice Nurse (APN) for One or More Stabilized Chronic Pathologies

The WHO and our governance advocate that health professionals should organize care around the patient, considering his or her values, needs and preferences, and enabling the patient to develop the capacity to self-manage the chronic health problems he or she faces. Chronic disease is an ongoing dynamic process and adaptation to this process is complicated by the interaction of several determinants: self-management capacity, level of health literacy, quality of life and experience of care. To best support chronic disease, the recommendation is to adopt a management strategy that allows chronic patients to play an active role in the management of their condition and in the day-to-day decision-making process. The management of chronic pathologies is one of the specialties in which Advanced Practice Nurses are positioned, in primary care, outside hospital. Nursing care benefits from care models that allow for more adapted responses, regarding particular care situations, or certain patient typologies. The Humanistic Partnership Health Care Model (MPHS) implement in current Advanced Practice Nurse (APN) practice.

ECHO for Diabetes and Multiple Chronic Conditions Study

Diabetes mellitus is a chronic condition that affects the body's ability to process sugar effectively, which over time can increase the risk of heart disease, high blood pressure, and kidney damage. Other chronic conditions include high cholesterol, obesity, and depression. Persons with diabetes mellitus and multiple chronic conditions (DMMC) face higher risks of losing physical or mental function, experiencing other chronic conditions, and death. Most of the residents of New Mexico (NM) belong to groups at risk for developing DMMC. Finding quality healthcare is a key factor, as NM also ranks among the largest, poorest, and most rural states. Primary care providers (PCPs) most often treat DMMC patients, but healthcare teams can lack confidence in managing these complex patients and struggle to keep up with recommended guidelines. This Project ECHO model (ECHO) for DMMC, a telehealth intervention for healthcare teams, can lead to lower blood sugar levels in DMMC patients being treated at NM primary care clinics. ECHO is a "telementoring" program that trains healthcare teams to provide specialized medical care at their local clinics. This is done by connecting healthcare teams with specialist mentors at academic medical centers through videoconferencing sessions. During ECHO program sessions, groups of healthcare teams hear lectures on key topics in DMMC care from experts, and then give presentations of anonymous patient cases by a healthcare teams for discussion and to receive recommendations. This clinical pragmatic trial aims to learn if the intervention will improve patient blood sugar levels in persons with DMMC who are being treated at selected health clinic sites throughout New Mexico. The study aims to answer: * Whether a 0.5% drop in HbA1c on average can be achieved in the group whose healthcare teams are receiving the ECHO intervention compared to the comparator group, whose providers will not receive the intervention. * Whether the rate of an individual's HbA1c was greater than 8.5% at the baseline will be reduced by 15% at the end of the intervention. Researchers will compare health data for patients empaneled to healthcare teams in the study and the usual care comparator group both before and after the intervention period to see whether the ECHO model has a positive influence on test results.

Biospecimen Analysis in Detecting Chemical Concentrations in Patients With Chronic or Infectious Diseases Receiving Meditations

This trial collects and analyzes sweat and saliva samples compared to blood in detecting chemical concentrations in the body in patients with chronic or infectious diseases receiving medications. Wearable sweat sensors are capable of monitoring electrolytes and metabolites (sodium, potassium, glucose, lactate, etc.) for health monitoring and disease diagnosis. Designing wearable sweat sensors capable of providing information regarding drug administration may be challenging due to ultralow concentrations in biofluids. This trial seeks to determine if the use of a smart wristband can accurately measure the levels of chemicals and substances in sweat.