4,148 Clinical Trials for Various Conditions
We will conduct a comparative effectiveness randomized clinical trial with two "active comparator" arms. We will evaluate the two current, usual care strategies (higher intensity "telephonic navigation" vs. lower intensity "virtual outreach") for addressing social needs among patients with multiple chronic conditions.
African Americans have higher rates of diabetes, obesity, heart disease, and high blood pressure. In addition, middle-aged non-Hispanic Black adults develop multiple chronic conditions (MCCs) at an earlier age, which share most of the same risk factors, including poor diet and physical inactivity. The major goal of the proposed project is to develop a culturally tailored intervention focused on improving awareness, knowledge, diet quality, and physical activity in a cohort of AA adults with MCCs.
Nearly half of adults in the United States (47 percent, or 116 million) have hypertension, also known as high blood pressure (BP). Uncontrolled high BP can be devasting as it can lead to stroke, heart attack and kidney failure, as well as other numerous health conditions. Hypertension can be controlled; however, only one in four of adults with hypertension have their BP controlled. The chance of having high BP increases as one ages, requiring the need to examine effective hypertension strategies in older adults. The issue of hypertension management is compounded even further among older U.S. adults who live with multiple chronic diseases. National organizations identified several effective health systems strategies for improving rates of BP control, including patient self-measured blood pressure (SMBP) monitoring. SMBP involves a patient's regular use of personal BP monitoring devices to assess and record BP across different points in time, typically at home. The evidence base for utilizing SMBP strategies in healthcare systems and practices is strong. However, there is not research regarding SMBP including how to include it into workflow in primary care clinics. Previous research has shown SMBP is beneficial, but more information is needed regarding whether SMBP is beneficial in high-risk populations (such as rural, older adults or Black, older patients). The research team will test whether SMBP with normal clinical support vs SMBP with clinical pharmacist support improves BP in older adults living with multiple chronic conditions. The addition of a pharmacist has been shown to improve patient outcomes, though the effectiveness of SMBP with a clinical pharmacist in older adults is not known. The primary outcome will be change in systolic BP over 12 months. The secondary outcome will be self-reported treatment burden over 12 months, using a validated tool called the Multimorbidity Treatment Burden Questionnaire. The research team plans to include a subgroup of rural, older adults and Black, older adults and will not exclude older adults who have dementia.
The goal of this clinical trial is to learn if the implementation of the WE CARE social determinants of health (SDOH) screening and referral intervention with an antiracist lens in primary care settings can lead to a meaningful decrease in chronic disease by monitoring conditions such as hypertension, diabetes, depression, hyperlipidemia, and asthma through clinical measures. The main question it aims to answer is: Does the WE CARE SDOH screening and referral intervention applying an antiracism lens informed implementation strategies have the potential to reduce racial/ethnic health inequities in chronic diseases for minoritized patients?
The goal of this pilot clinical trial is to learn if providing a clinical decision framework for managing older adults chronic conditions during hospitalization to inpatient clinicians improves clinicians' ability to individualize chronic condition prescribing decisions for hospitalized older adults (65 and older). The main questions it aims to answer are: * Will the clinical decision framework lead to clinicians having greater confidence to individualize discharge prescribing? * Will clinicians using the framework discharge make fewer changes to hospitalized older adults with home diabetes and hypertension medications than they did prior to receiving the framework? * Will older adult patients of participating clinicians will report fewer gaps in understanding of medication changes after the clinician is exposed to the framework? Researchers will compare participating clinician survey responses and prescribing records from before and after an educational session presenting the clinical decision framework. Participants will be asked to * Attend a one-time educational session on the clinical decision framework * Complete 2 electronic surveys, one before and one following the educational session. * Agree for researchers to contact their patients, in order for patients to complete a one-time phone survey about changes made to home medications during hospitalization and quality of communication from the hospital team.
The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \>30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.
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.
The goal of this observational study is to assess the clinical response and the effect of autophagy function in patients before, during and throughout oral low dose sirolimus (rapamycin) therapy. The main questions this study aims to answer are: * Does rapamycin reduce the overall symptom burden in this patient population and does it improve the quality of life? * Does rapamycin change mTOR driven autophagy deficits observed in a subset of patients? Participants will be asked to complete a series of questionnaires and quality of life instruments before starting rapamycin therapy prescribed by their physician and throughout their course of treatment. Study blood samples will be collected before starting therapy and throughout the course of treatment to assess serological markers of autophagy function.
This study is a longitudinal cohort study that follows participants in a randomized clinical trial of a program of prenatal and early child home visiting on maternal and offspring risks for chronic disease.
Developed nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings.
A study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.
Cardiovascular disease (CVD) is responsible for 1 out of every 5 deaths, is the number one killer of Americans, killing about 700K US adults per year (1). Our proposed research is a clinical trial that will determine the effects of feeding California freeze-dried grapes (which are directly comparable to fresh table grapes), on cardiovascular and chronic disease risk factors, namely, blood glucose and lipids (total cholesterol, LDL, HDL, and triacylglycerides), electrolyte and blood indicators (such as sodium, calcium, potassium, etc.), c-reactive protein (hs-CRP) and tumor necrosis factor alpha (TNF-alpha) (measures of inflammation and CVD risk), body composition (body weight, body fat percentage, lean tissue weight, body water amount and Kcal requirement to maintain body composition status), and blood pressure (BP) in 30 adults. The investigators will test satiety and hunger to see if grape antioxidants decrease both, implying that there will be a decrease in caloric intake and result in body composition improvements.
This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling, and others) of a subset of common patient care indications.
To establish the effectiveness and tolerability of standard of care anti-anginal treatment (beta-blocker and calcium channel blocker medications) in older adults with symptomatic Stable Ischemic Heart Disease (SIHD) and multiple chronic conditions (MCC).
This project will evaluate a proactive outreach intervention for tobacco cessation among primary care BIPOC populations who smoke in two health systems across the region. Compared with Whites, BIPOC populations in the US experience disproportionate health consequences from commercial cigarette use. Few evidence-based cessation treatments (EBCTs) have been specifically developed, evaluated, or implemented for BIPOC populations. Moreover, uptake of EBCT (e.g. medication, counseling) is lower among BIPOC populations. Reasons for the failure to engage BIPOC patients in EBCTs are complex and multi-level (e.g., patient, provider, healthcare system). To address these gaps, the investigators will assess the added effectiveness of an approach to augment the standard of care with longitudinal proactive outreach to connect BIPOC adults with EBCT. The proposed multi-level intervention leverages the electronic health record to identify patients who smoke, who can then be proactively engaged via culturally tailored outreach to connect them to EBCT. The proactive approach may circumvent experiences of bias within the healthcare system and thus enhance engagement.
This study tests a web-based chronic disease risk reduction intervention among rural adults.
Approximately 45% of older adults in the U.S. have 2 or more chronic health conditions (e.g., arthritis, hypertension, diabetes) in addition to functional limitations that prevent performance of health self-management activities. Self-management continues to be the gold standard for managing MCC, but functional limitations create difficulty with these activities (e.g., physical activity, symptom monitoring). Restricted self-management accelerates the downward spiral of disability and accumulating chronic conditions which, in turn, increases rates of institutionalization and death by 5-fold. Currently, there are no tested interventions designed to improve independence in health self-management activities in older adults with MCC and functional limitations. Research suggests that older adults are more likely to change behavior with interventions that assist with planning health-promoting daily activities, especially when contending with complex medical regimens and functional limitations. Combined with occupational therapy (OT), behavioral activation (BA) shows promise to improve health self-management in populations with chronic conditions and/or functional limitations. This innovative combination uses the goal setting, scheduling/monitoring activities, and problem-solving components of the BA approach as well as the environmental modification, activity adaptation, and focus on daily routines from OT practice. The investigators will test the effect of this combined approach in a Stage I, randomized controlled pilot feasibility study compared to enhanced usual care. The investigators will recruit 40 older adults with MCC and functional limitation and randomize 20 to the PI- delivered BA-OT protocol. This research will inform modification and larger-scale testing of this novel intervention and provide data for a federally funded career development award.
The purpose of this study to pilot test an accessible and inclusive artificial intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4CHRON) for health-related quality of life for adults with impaired mobility and chronic medical conditions.
This clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy lifestyle practices, increasing physical activity and encouraging healthy eating behaviors. EML is a series of free culturally and linguistically appropriate nutrition and physical activity sessions. The interactive education segment of the EML Program is culturally responsive, and based on the community EML program, and topics will include: nutrition guidelines, reading food labels, recipe modification and healthy food preparation, eating healthy on a budget, chronic diseases information and prevention strategies. The EML program may help reduce the risk of cancer and chronic diseases by encouraging more physical activity and healthy eating behaviors.
The purpose of this study is to determine the mechanistic effects of an ionic calcium supplement in adults with atrial fibrillation, osteoarthritis, and hypertension. The study aims to determine if ionic calcium supplementation affects quality of life, rate of biological aging, bone densitometry, and blood biomarkers of bone metabolism over a six month period compared to non-ionic calcium comparator supplement.
This is a national-level research study of primary care physicians. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling and other) of a subset of common patient care indications.
The purpose of this study is to investigate the effect of providing healthy foods and nutrition education on participants' body weight, blood pressure, and average blood sugar level. The healthy food offerings tested in this study will help determine which option is best to improve health outcomes among Cleveland Clinic Akron General patients with chronic conditions. Findings from this study could guide doctors in deciding on appropriate nutrition and dietitian services for Cleveland Clinic patients.
The purpose of study is to evaluate whether home visit programs are an effective method for HTN and T2DM management as compared to standard of care clinic visits.
The purpose of this study is to investigate whether the self-management of diabetes and hypertension can be improved with the use of mobile monitoring devices and nursing support.
The goal of this study is to determine the most effective messages for encouraging patients with chronic conditions, who have not seen their doctor in at least one year, to return to the clinic. Study participants will receive postcards or letters encouraging them to make an appointment. Researchers will assess whether messages increase appointment scheduling (and attendance).
The investigators will conduct a randomized control trial enrolling 366 older Veterans with multiple chronic conditions receiving primary care at the Michael E. DeBakey VA Medical Center and VA Connecticut Medical Center to determine if Patient Priorities Care reduces treatment burden, increases priorities-aligned home and community services, and sets shared health outcome goals compared with usual care. The investigators will randomize at the patient level rather than clinic or clinician level to evaluate the effect of identifying patient priorities on clinician decision making and alignment of care with identified priorities.
When patients survive a severe brain injury but fail to fully recover, they often enter a Disorder of Consciousness (DoC) --that is, a set of related conditions of decreased awareness and arousal including the Vegetative State (VS) and the Minimally Conscious State (MCS). When these conditions become chronic, there are no approved treatments to help bolster any further recovery. In prior work, we have shown the clinical feasibility and potential of Low Intensity Focused Ultrasound Pulsation (LIFUP) as a remarkably safe form of non-invasive brain stimulation in these conditions.
The proposed study, NC Works4Health (NCW4H), builds on the strengths of long-standing academic-community research partnerships between this UNC at Chapel Hill (UNC) team of investigators and key stakeholders across health, social service, employment, and economic development sectors. The overall goal of this study is to test the effectiveness of a multilevel intervention that can be readily adopted by communities to reduce chronic disease risks in socioeconomically disadvantaged populations by (a) embedding prevention efforts in DSS-E programs at the individual level, and (b) enhancing supervisor supports for DSS-E hires at the employer level. Interventions at each level, and their joint effects, are designed to mitigate the psychological, behavioral, and clinically relevant risks for chronic disease onset, morbidity, and comorbidity that accrue with unemployment and the employment-entry transition.
Solve Together is a platform designed to collect clinical data about post-infectious diseases, including ME/CFS and Long Covid. This data is made available to researchers and will be used to identify participants eligible for clinical studies. The platform also empowers patients to make reports for their doctors, connect medical records and/or a health-tracking wearable device, and identify their unique symptoms and health patterns.
Healthcare for older adults with multiple chronic conditions (MCCs) is burdensome and of uncertain benefit, resulting in unwanted and unhelpful care. Patient Priorities Care (PPC) aligns care with patients' health priorities (i.e. the health outcomes most desired given the healthcare each is willing and able to receive). The aim of this project is to test, using a parallel group design involving 2 matched primary care sites, whether PPC decreases patient treatment burden and unwanted and unnecessary health care as well as assess what the value of this program is for patients.