Clinical Research Directory

Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence

Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations.

Genetic Variants and Susceptibility to Diseases of Prematurity in Very Low Birth-Weight Infants

The purpose of this study is to determine if sequence variations in genes involved in the development and function of vulnerable organs increases susceptibility to chronic lung disease (CLD) and other diseases affecting premature infants, such as necrotizing enterocolitis (NEC), sepsis, patent ductus arteriosus (PDA) and intraventricular hemorrhage (IVH). The study will also determine whether measurement of certain biomarkers in serum will identify infants who will develop these complications of prematurity. Previous studies from this institution and others have identified genetic variants in some genes, such as toll like receptor genes are associated with higher risk of CLD or NEC. The interaction of these variants with other gene variants that can influence the risk of these diseases remains unclear.

Inspiratory Muscle Training Immediately After Lung Transplantation

Following lung transplantation (LTX), patients may exhibit respiratory and skeletal muscle weakness that will affect exercise capacity, increase dyspnea and fatigue, limit activities of daily living (ADL) and decrease quality of life. Inspiratory muscle training (IMT) has been extensively studied in a variety of non-LTX populations and research has shown that IMT improves exercise capacity, diaphragmatic thickness, and reduced dyspnea during activities of daily living and improved quality of life in patients with advanced lung disease. The aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer device in addition to standard physical therapy in the acute phase of rehabilitation following LTX. Patients targeted for enrollment will be those with any type of advanced lung disease requiring LTX with the objective of demonstrating improvements in respiratory muscle recovery, perceived dyspnea, severity of fatigue, and overall functional status following the transplant procedure.

Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise

This study aims to more accurately assess cardiac function, ventilation and exercise capacity in a non-invasive fashion, and to better characterize exercise intolerance in the setting of three populations of individuals with chronic diseases of childhood (acute lymphoblastic leukemia (ALL), chronic lung disease (CLD) of prematurity, and post-heart transplant (HT))

Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients

The study will have two separate patient cohorts: Cohort 1 will include patients with newly diagnosed chronic graft versus host disease (GVHD), whereas cohort 2 will include patients with newly diagnosed chronic lung disease (CLD). For cohort 1, the primary objective will be to characterize PRM metrics at the onset of chronic GVHD and determine if a PRM signature is present that will predict 1-year CLD free survival. For cohort 2, the primary objective will focus on characterizing PRM at the onset of CLD and determine if PRM can predict the trajectory in lung function decline in affected patients.

Using Parent Engagement to Improve the Wellbeing of Black Premature Infants With Chronic Lung Disease

The goal of this pilot study is to test the feasibility and acceptability of a collaborative goal setting intervention to improve parent engagement of Black preterm infants with chronic lung disease in primary care. Preliminary impact on child and parent outcomes will also be explored. The main questions it aims to answer are: 1) Will parents complete a pre-visit questionnaire that asks about goals for the child? 2) Does use of the pre-visit questionnaire help parents to achieve self-identified goals? Participants will fill out a pre-visit questionnaire prior to the child's well visit. The participants will then complete two surveys after the visit (1 week and 2 months after).

Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension

Prospective observational study to determine if the PVD-B65 risk score for one-year mortality in patients with chronic lung disease and pulmonary hypertension (CLD-PH) can accurately risk stratify these patients and successfully predict one-year mortality from time of pulmonary hypertension diagnosis. PVD-B65 risk score was developed in a retrospective cohort of patients with CLD-PH, utilizing the presence of pulmonary fibrosis without emphysema, pulmonary vascular resistance (PVR) \> 5 woods units (WU), 6-minute walk distance (6MWD) \< 150 meters, B-natriuretic type peptide (BNP) \> 200 pg/mL or N-terminal pro-natriuretic type peptide (NT-proBNP) \> 300 pg/dL, and age \> 65 years as the score components.

Paediatric Post-TB Pulmonary Rehab Study

The goal of this clinical trial is to learn if a home-based pulmonary rehabilitation program is feasible and acceptable for children ages 6-15 who have recently completed treatment for pulmonary tuberculosis. The main questions it aims to answer are: Can children and caregivers follow a 6-week rehabilitation program? Is the program acceptable and feasible for children and caregivers? Researchers will also explore preliminary changes in walking distance and quality of life. Participants will: Attend a clinic visit for baseline testing, including a 6-minute walk test (6MWT) and the St. George's Respiratory Questionnaire (SGRQ) Receive exercise instructions and a pedometer Complete home-based walking and wall sit exercises twice per week for 6 weeks Receive weekly follow-up from study staff (by phone or home visit) Return to clinic at 6 weeks for follow-up testing

Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE)

Background: Some health conditions make breathing difficult and uncomfortable. When this happens every day, it is called chronic breathlessness. Over 3 million people living with heart and lung disease have chronic breathlessness in the UK. Breathlessness is very difficult for patients themselves and their families, resulting in disability and feelings of fear, distress, and isolation. Due a to lack of supportive breathlessness services many patients frequently attend hospital Accident and Emergency (A\&E) departments seeking help. Given the on-going challenges faced by the National Health Service (NHS) in the United Kingdom, such as long waiting times, staff shortages, increased demand for services because of the COVID-19 pandemic, there is an urgent need to develop new ways to support those living with chronic breathlessness. One potential solution is to offer support online, as it is estimated that in the UK, 7 out of every 10 people with chronic breathlessness are internet users. With the help of patients and NIHR funding the research team lead by Dr Charles Reilly, developed an online breathlessness supportive website called SELF-BREATHE. SELF-BREATHE provides information and self-management tools such as breathing exercises, that patients can do at home themselves. SELF-BREATHE has been tested as part of its development. SELF-BREATHE is acceptable and valued by patients. But what is unknown is whether SELF-BREATHE improves patients' breathlessness and their life? This is the question this research seeks to answer. Aims 1. To test if using SELF-BREATHE for six-weeks improves patients' breathlessness, their quality of life and whether SELF-BREATHE should be offered within the NHS 2. To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have for patients. Methods The research team are undertaking a randomised controlled trial. For this, 246 people living with chronic breathlessness will be recruited in to this study. Each person will be randomly chosen by a computer to continue with their usual care or their usual care plus access to SELF-BREATHE. All study participants will complete questionnaires at the start of the study, thereafter at seven and twelve weeks after randomisation. These questionnaires will ask patients about 1) their breathlessness and its effect on their life and 2) planned and unplanned hospital visits. At the end of the study, we will compare answers to these questionnaires between the two groups at seven and 12 weeks. This will tell if SELF-BREATHE improved patients' breathlessness and reduced their need for unplanned hospital visits e.g., A\&E attendances due to breathlessness.

Utility of Lung Clearance Index Score As a Noninvasive Marker of Small Airways Disease

To determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of small airways disease in adults with chronic lung conditions compared to healthy adults, adjusting for age, sex and smoking status.

Awareness of Individuals with Chronic Lung Disease About Climate Change, Heat Waves, Air Pollution and Physical Activity

Climate change is characterized by global temperature increase, melting of glaciers and increasing temperature of ocean waters. Increase in greenhouse gases such as nitrogen and carbon dioxide negatively affects air and water quality. Extreme events such as extreme heat waves, floods and hurricanes are events seen with climate change. It is known that climate change and air pollution have negative effects on public health. Its adverse effects are often seen in individuals with rhinosinusitis, asthma and chronic obstructive pulmonary disease. Air pollution is expected to increase due to the ongoing economic growth and population growth worldwide, resulting in more respiratory diseases and disease burden. This study aims to assess the awareness level of individuals with chronic lung disease on climate change, heat waves, air pollution and their interaction with physical activity and anxiety and depression levels, and to better understand the experiences of patients and learn their perspectives. Within the scope of the study, it is planned to provide patients brief information on this subject and receive feedback about this information.

Prevention of Chronic Lung Disease (CLD - Prevention Study)

Primary endpoint: \- prospectively identify potential biomarkers able to predict the severe course of pulmonary funcion in the first 12 months of life and realize a new profile to early identify hugh risk newborns Secondary endpoints: * detect genetic variance causation model (by MiSeq Illumina platform) correlating with severe pulmonary dysfunction and asthma development; * detect MIcroRNAs as well as anti- and pro-inflammatory cytokine variations (MIP-1α, MCP-1, IL-8, TNF-α, IFN-ɣ, IL-10) correlating with the severity of pulmonary dysfunction in the first 12 months of life and the risk of asthma development Population: preterm infants with gestational age \< 32 weeks who have suffered from acute respiratory insufficiency at birth Intervention: * Assessment of prenatal risk factors. * Collection of the following biological specimens: 1) a vaginal swab from the mothers of enrolled infants 2) a placenta sample 3) an arterial or venous cord blood sample at birth 4) peripheral blood samples from enrolled infants: the first within 48 hours of life, the subsequent ones at 7 and 28 days of life and at 6 and 12 months of age 5) bronchoalveolar lavage (BALF) samples exclusively in infants intubated for clinical reasons within the first 24 hours of life, at 7 and 28 days of life. 6) first meconium sample issued and subsequent stool samples at 7 and 28 days of life and at 6 and 12 months of age, of enrolled infants * Respiratory Functionality Testing at 6 and 12 months of age

Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training

Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease. Typically, oxygen is administered at a constant flow rate. However, due to fluctuating activity levels, patients' oxygenation status can vary, potentially leading to oxygen desaturation and increased dyspnoea. Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow. The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients' perceived dyspnoea during exercise endurance training.

Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease

The goal of this pilot clinical trial is to compare telehealth and onsite supervised maintenance exercise program for adults with Chronic Lung Disease. The specific aims of the study are: * To compare 8-week supervised maintenance program delivered onsite and via tele-rehab with no maintenance for patients with Chronic Lung Disease following discharge from traditional exercise or physical therapy or onsite outpatient rehabilitation programs on clinical outcomes (dyspnea, exercise capacity, physical function, physical activity, and quality of life) at 8 weeks and 4-months post-intervention. * To compare the differences in dyspnea, exercise capacity, physical function, physical activity, and quality of life between an 8-week maintenance program delivered onsite and via tele-rehab at 8-weeks and 4-months post-intervention in patients with Chronic Lung Disease following discharge from traditional onsite outpatient rehabilitation. Participants in both intervention groups (onsite and tele-rehab) will undergo a baseline onsite assessment followed by an 8-week supervised exercise intervention either onsite or in a telehealth setting. Control group will receive biweekly check in calls, but no active intervention.

Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction

Lung transplantation is the only therapeutic alternative for more and more patients with respiratory diseases in their most advanced stages. The most limiting factor to achieve long term survival si chronic lung allograft dysfunction, a multifactorial disease without an effective treatment. The immunomodulatory capacity of mesenchymal stem cells enables them to be a potential therapeutic agent for this condition. The objective of this study is to assess the safety of endobronchial administration of allogeneic MSCs in patients with chroniclung allograft dysfunction.

Comparing Centre-based, Remotely Supervised, and Self-administered STS Tests in Individuals With CRD

Despite evidence on the psychometric properties of sit-to-stand (STS) tests in chronic respiratory disease (CRD) populations, most studies have been conducted face-to-face. Given the recent emphasis on virtual pulmonary rehabilitation (VPR), there is a need to identify reliable and valid exercise tests that can be delivered in home-based settings, either supervised remotely or self-administered by patients. A repeated-measures crossover design will be used to test the home-based administration of STS tests. The 30-second STS (30-s STS) and 1-minute STS (1-min STS) tests will be randomly administered across three test conditions (centre-based, remotely supervised, and self-administered). Data will summarize the feasibility of remotely supervised and self-administered STS tests and compare the performances of centre-based tests with remotely supervised and self-administered versions of STS tests in patients with CRD.

Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients

Lung transplantation is an effective therapeutic option in the end-stage of chronic respiratory diseases. Lung transplantation improves lung function in terms of capacity and volume. However, the transplanted patient still suffers from muscle weakness and exercise intolerance. In recent years, respiratory physiotherapy work has intensified in critically ill patients with respiratory muscle weakness and the application of inspiratory muscle training (IMT), which has been shown in several studies to increase inspiratory muscle strength (IMT), improve ventilation and reduce the sensation of shortness of breath. Despite this emerging evidence, inspiratory muscle training (IMT) is not standard practice in most ICUs around the world, nor is it included in a protocolised manner among the components of a pulmonary rehabilitation programme. Given the limited evidence, the investigators propose to conduct this randomised controlled clinical trial in lung transplant recipients. The study will compare two groups of transplanted patients, a control group that will follow the rehabilitation programme and standard medical care and another experimental group that will also perform inspiratory muscle training. This study aims to analyse the effect of IMT on inspiratory muscle strength, exercise capacity and quality of life in lung transplant patients.

Feasibility of Proteomics in Chronic Lung Disease With Sarcopenia

Sarcopenia, the loss of muscle mass and strength with ageing, is a prevalent condition in older adults, particularly those with chronic lung diseases like COPD and interstitial lung disease. The condition exacerbates the decline in physical ability, leading to decreased mobility, impaired quality of life, and increased disability. Sarcopenia's prevalence varies across populations, estimated to affect up to 10% of adults over 60 worldwide, with higher rates reported in studies employing consensus definitions of sarcopenia. The prevalence is even higher in patients with chronic lung diseases, reaching up to 26.6%. Sarcopenia's impact on health-related quality of life has been widely investigated. The condition is associated with various comorbidities, including chronic heart failure, obesity, diabetes, and chronic kidney disease, all negatively impacting the quality of life. The proposed study's primary aim is to assess the feasibility of the FACS (finding, assessing, confirming, severity) approach in determining sarcopenia's prevalence in the chronic lung disease population. FACS includes screening, strength measurements, and bioelectrical impedance analysis (BIA) to confirm sarcopenia. The study will also explore potential mechanisms associated with sarcopenia in this population, using proteome and single-cell transcriptome profiles. These multi-omics approaches provide a comprehensive view of the cellular and molecular changes underlying sarcopenia.In particular, the study will evaluate patient acceptance, time efficiency of each test, and recruitment effectiveness. The outcomes will guide the design and execution of subsequent, larger studies and provide preliminary data for power calculation for the full-scale study.