148 Clinical Trials for Various Conditions
This pragmatic clinical trial is being conducted to test the effectiveness of I-SITE (Implementation for Sustained Impact in Teleophthalmology), an implementation program to sustain increased diabetic eye screening rates using teleophthalmology in rural, multi-payer health systems. Up to 10 rural health systems providing teleophthalmology to 10,000 patients with diabetes and 100 clinical care personnel participating in the I-SITE intervention will be enrolled for up to 48 months.
Through this pilot study, investigators will test an innovative approach to implement survivorship care planning at three sites located in or adjacent to rural counties. The pilot data will inform a subsequent multi-site Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and clinical effectiveness outcomes.
This pre-post study will evaluate the implementation of a cardiovascular telehealth platform, which will connect experts from the Wake Forest University Health Sciences (WFUHS) tertiary care center with Wilkes County Emergency Medical Services (WC-EMS) system, Wilkes Medical Center Emergency Department (ED), and The Wilkes County Health Department Public Health Community Clinic (PHCC) to improve cardiovascular care in this rural community.
The principal objective of the study is to determine if patient-empowered, real-time and home- based patient monitoring of vital parameters can lead to: * Reduction in admission rates and improved clinical management of chronically ill patients * Reduction in use of medications * Reported quality of life A minimum of 100 patients will be recruited, monitored and observed over 6 months from home with the Coala Heart Monitor. The study population will be representative of rural, high-risk, Medicare (65+ of age) subjects with chronic conditions and will be recruited by the Perry Community Hospital in Linden, TN.
The objective of this project is to assess the fidelity and sustainability of in improving provider performance with Ankle Brachial Index (ABI) assessment and ulcer staging with the would ischemia foot infection (WIfI) tool for new patients with lower extremity ulcers due to peripheral artery disease (PAD) and diabetes mellitus (DM) at RHCs in the telemedicine network through a rural provider education program that is aligned with preexisting continuing medical education activities.
The purpose of the Alabama Veterans Rural Health Initiative is to better understand access and barriers to health care and to enhance veteran enrollment or engagement in health care services of veterans residing in rural areas. It describes an intervention that is adaptable for use by other VA facilities that serve veterans in rural settings, and importantly, this study will improve our understanding of barriers to care and evaluate a method for enhancing access to care. The anticipated impact is that more veterans in rural areas who were previously under-utilizing VA services will receive and attend a health care appointment. This gain may improve preventative and primary care health care and reduce long term health care morbidity, expense and burden. This study may also identify previously unknown barriers to care that can be surmounted by innovative access and health care delivery approaches. The primary objective is to evaluate an innovative approach for enhanced enrollment and engagement outreach intervention (EEE intervention) for rural veterans in VA health care services. This study entails a two-cell design, addressing this objective with a prospective, randomized controlled multi-site clinical trial that evaluates an active intervention compared to administrative outreach (AO, control condition) on whether or not a rurally-residing veteran obtains and attends a VA appointment.
The study will include patients who require elective major abdominal surgery for cancerous or non-cancerous conditions. The goal of the research is to assess the benefit of a prehabilitation program before surgery that includes nutrition, exercise, smoking cessation, and optimization of chronic disease. A group of 10 patients will take part in a prehabilitation program. These patients will be compared to 20 patients who received standard of care.
Research purpose: The purpose of this pilot study is to assess obese clients for two phenotypes, those testing positive and those testing negative for Food Addiction (FA) (Yale Food Addiction Scale, YFAS) and determining the efficacy of four treatments: usual care (IC, dietary and physical activity instruction), individual motivational interviewing alone (MI), individual MI with pharmacotherapy (MI+P) for improving outcome measures within each phenotype, and pharmacological therapy (P). Background/significance: Obesity has long been an epidemic in the U.S. and other countries. Numerous approaches have been tried to address obesity with limited success. The YFAS is a relatively new, validated instrument that can help researchers and practitioners assess obese clients for food addiction. Meeting the YFAS diagnosis criteria for FA suggests the need for a stronger intervention with close monitoring to assist these clients in self-management of their eating and physical activity behaviors. Proposed methods/approach: The investigators propose assessing obese clients with the YFAS as part of their intake once they are referred to the Healthy Behaviors Clinic by Regional West physicians/practitioners. A nurse researcher with expertise in MI and a nurse practitioner will perform intake assessments, obtain consent and randomly assign participants in each phenotype (positive or negative for FA) to one of three treatment groups (usual care, individual MI alone, and individual MI with pharmacotherapy). Interventions will occur over 6 months. A clinical psychologist with expertise in the YFAS (University of Michigan) will serve as a consultant on this project and a registered dietitian (University of NebraskaLincoln) will serve as a co-investigator. Expected outcomes: The investigators expect that MI and MI+P and P will be more effective in improving outcome measures than IC. We also expect that response to the treatments will differ between the two obesity phenotypes (those testing positive and those testing negative for FA).
The University of Texas Health Science Center at San Antonio (UTHSCSA) will serve as the site for the RURAL Study Coordinating Center, led by PI Vasan Ramachandran, MD. The primary function of the Study Coordinating Center (SCC) is to serve as an administrative liaison between all of the RURAL study's cores. The SCC schedules, facilitates, and hosts, all RURAL meetings including preparation for Observational Study Monitoring Board (OSMB) meetings, and maintains direct communication with the study's program officers at NHLBI. The SCC monitors the overall progress of RURAL and keeps all RURAL cores abreast of study updates through meetings, emails, newsletters. It also maintains the official RURAL website and serves as an administrator for investigators seeking to collaborate with RURAL through the submission of Ancillary Studies. The SCC will have no direct interaction with any participants, nor will it have access to identifiable data.
The current study is a multilevel factorial design RCT with interventions at the clinic (Healthy Clinic intervention period vs. Control period) and individual patient levels (iAmHealthy vs. Newsletter).
The study will utilize an exploratory study design, applying formative research methods to inform the development and pilot testing of an unintended teen pregnancy prevention intervention.
Buprenorphine is an evidence-based treatment for opioid use disorder that also has strong potential to reduce HIV transmission in people who use drugs. Rural health care professionals are eligible and critically needed to provide these medications, but stigma currently limits provider willingness to prescribe buprenorphine, especially in regions where mortality and HIV transmission secondary to opioid use are high. In this developmental trial, the investigators will adapt, refine, and test the feasibility of a prototype brief stigma-reduction training intervention aimed at increasing buprenorphine prescribing in the rural primary care setting.
There is a need to develop evidence-based interventions that rural food pantries can use to limit the distribution and intake of ultra-processed foods and promote the distribution and intake of minimally processed foods in the food environment and among low-income populations to promote better dietary quality and health outcomes. This research project, The UnProcessed Pantry Project (UP3): A Novel Approach to Improving Dietary Quality for Low-Income Adults Served by Rural Food Pantries, uses the Social-Ecological Model to target multiple levels, including the food supply in the rural study location (community level), the food environment at the food pantry (environmental level), and participant dietary intake (individual level). Aim 1 will adapt evidence-based strategies to inform UP3. UP3 will improve dietary quality by influencing the food supply through organization-wide nutrition policies, modifying the food environment with minimally processed foods and nudges, and changing participant dietary intake through experiential nutrition education. The UP3 pilot study will be conducted during Aim 2 with 40 participants served by two rural food pantries in Montana. The purpose of the pilot study is to investigate potential short-term effects on nutrient intake and dietary quality (primary outcome), assess acceptability of UP3 among participants, and evaluate feasibility in rural food pantry environments. It is hypothesized that UP3 will improve access to minimally processed foods and decrease access to ultra-processed foods at the food pantry, which will improve overall dietary quality of individuals as measured by the Healthy Eating Index-2015 compared to baseline and to the control group. Demographic and food security data will characterize the population. Psychosocial factors will be collected to understand changes in knowledge, attitudes, and perceptions about processed foods. Biomarkers of health data (i.e., weight, systolic blood pressure, HbA1c, fasting lipid panel) will be collected to determine the feasibility of measuring potential short-term health effects alongside UP3. A control group of 20 participants at a rural food pantry will be used to assess dietary intake, psychosocial factors, height, and weight. Aim 3 will tailor UP3 for a scalable intervention suited for an R01 grant application to conduct a randomized controlled trial (RCT). UP3 is positioned to demonstrate the positive effects of limiting processed foods and increasing unprocessed and minimally processed foods on diets and, potentially, health among low-income populations. The short-term goals of this research are to develop an adaptable and scalable intervention suitable for rural food pantries serving low-income populations, as well as potentially contribute to a knowledge base around potential short-term effects of the minimally processed foods diet on dietary quality and health risks in those populations. The longer-term goals are to test the efficacy of the intervention in an RCT and then disseminate the approach to be integrated into rural food pantries serving low-income populations with the goal of decreasing health risks.
The goal of the proposed project is to see if an innovative family-based intervention can reduce childhood obesity by actively engaging the whole family in promoting healthy behaviors in the home. In addition, the project will also examine how the NU-HOME family intervention influences children's dietary intake, availability of healthy and unhealthy foods in the home and served at meals and snacks, physical activity as a family, and child screen time (TV, game systems). The study will build upon a similar project conducted in an urban area and translate the lessons learned and adapt the program for a rural community.
The purpose of this study is to investigate health problems among rural Veterans. The research project also aims to test a new telephone-based approach for helping Veterans who need treatment connect with the appropriate care. This study will help us to better understand the kinds of problems Veterans experience. The study will also help us to find better ways to help Veterans get the help they may need.
Hearing loss is a major public health concern due to its negative association with emotional well-being, cognition, and physical ailments, such as diabetes. Access to audiologists and otolaryngologists in many regions across the US is poor or extremely limited. Rural populations are older, less educated, and have lower household incomes compared to populations in metropolitan areas. Also, with increasing age adults experience greater rates of hearing loss. Fortunately, the 2022 FDA Final Rule for Over-the-Counter Hearing Aids (OTC HAs) could revolutionize assess to hearing aids and hearing healthcare by allowing adults with perceived mild-to-moderate hearing loss to purchase these devices over the counter, without medical clearance or care from an audiologist. Pharmacies located in rural areas now have the option to provide OTC HAs, something previously not possible. Currently, however, there are no established guidelines for effective provision of these devices in pharmacies located in rural communities. Educating pharmacy technicians to provide basic hearing healthcare related to OTC HAs use could address a critical need and create a new care delivery model to ensure sustainable, long-term access to hearing healthcare. The long-term goal of this study is to create a sustainable interprofessional collaborative between audiologists and pharmacists for the development of a hearing healthcare model that improves access and affordability of care in rural regions across the country. The specific aims are to 1) Determine an effective approach for educating pharmacy technicians for the provision of OTC HAs in rural community pharmacies, and 2) Identify satisfaction of care provided by pharmacy technicians and initial performance with OTC HAs in adults with hearing loss living in rural communities. A stepped wedged clinical trial design will be used to study the effectiveness of a comprehensive educational training program for pharmacy technicians. Technicians from rural Alabama and Mississippi, placed within four different clusters, will participate in a multimodal training program for the purpose of developing basic clinical skills to assist adults with perceived mild-to-moderate hearing loss. Additionally, adults with hearing loss who receive clinical services from trained pharmacy technicians will be asked to report on the care they received and benefit from their OTC HAs. The central hypotheses are a) that pharmacy technician training will result in greater understanding of hearing healthcare concepts compared to no training, and b) the training will lead to successful provision of basic hearing healthcare to adults with hearing loss in rural communities. The expected outcome of this project will be the establishment of a multimodal education program, leveraging the increased access of OTC HAs, to support those with hearing loss in rural pharmacies across the county. The ability of pharmacy technicians to provide this support will dramatically increase the availability of hearing services in rural communities, which will positively impact the quality of life for those with hearing loss.
Participation in regular physical activity is vital to a healthy lifestyle. Research has shown that regular participation in physical activity among cancer survivors is not only able to improve health outcomes, but is also related to their quality of life. As we live in an age of technology, health wearables and smartphone apps might be one novel manner by which to help cancer survivors increase physical activity as well as improve health outcomes. Yet, the effectiveness of wearable and app as a tool for health promotion among cancer survivors is largely unstudied. The purpose of this study is to evaluate the effectiveness of a personalized m-health intervention via fitness wearable (Fitbit Inspire 3) exercise app (sFitRx) on physical activity, weight, quality of life, individual beliefs, and emotions among cancer survivors.
RAMP is a pilot study examining the use of an Attention-Deficit/Hyperactivity Disorder (ADHD) Monitoring Program during the early stages of treating ADHD in children living in rural settings. This trial will enroll 36 caregiver/infant dyads across 2 sites and will evaluate feasibility endpoints rather than clinical outcomes. Enrolled participants will be randomized 1:1 to the intervention group (RAMP reports) or control group (digital education handouts). The study duration is 10 months, including start-up, enrollment and intervention, and data analysis and manuscript submission.
Drawing from prior school-based skin cancer prevention programs, we have adapted intervention materials to target rural high schoolers. Program components (including in-class education) will be co-implemented by the research team and participating school staff, with a focus on sustainability beyond the immediate study period. Interviews and surveys following initial implementation will evaluate both the effectiveness of the program.
Expanded availability of virtual care encounters in Primary Care provides new opportunities to improve Veterans' outcomes by aligning encounter modalities with their needs and preferences. Yet, Veterans and their Primary Care physicians (PCPs) lack personalized information about the benefits and costs of different Primary Care modalities that is needed to maximize the value of Primary Care encounters. To address this problem, in this study the investigators will use surveys and interviews to identify what Veterans and PCPs perceive to be the benefits and optimal uses of different Primary Care encounter modalities. They will then supplement their existing system for communicating encounter costs to Veterans and PCPs with new interactive messaging about benefits and optimal uses of different encounter modalities. Finally, this novel Advancing Decisions about Virtual Service Encounters (ADViSE) intervention will be optimized through user-centered refinement before evaluating its effects on Veteran-centered outcomes, use of virtual care, and intermediate health outcomes in a randomized controlled trial (RCT).
This study assesses the effectiveness of colorectal cancer (CRC) screening intervention, mobile Patient Technology for Health (mPATH™-Cloud), compared to usual care among subjects who are overdue for CRC screening according to recommendations of the United States Preventive Services Taskforce (USPSTF). The trial randomly selects and enrolls 1,000 eligible subjects served by one federally qualified health center (FQHC) in North Carolina. Subjects are randomized to two study arms, Usual Care (Arm 1) or Mobile Health Decision Support (Arm 2). Usual care consists of a visit-based screening recommendation to complete a stool test (e.g., FOBT, FIT, Cologuard) or referral to a screening colonoscopy. Subjects randomized to the Mobile Health Decision Support (Arm 2) are sent a message by text or US mail, depending on their preferred communication mode as indicated in the electronic health record (EHR), to visit the mPATH™-Cloud website. Subjects who engage with mPATH™-Cloud are invited to answer brief questions to confirm their eligibility and then view a short decision aid video designed to help people choose the CRC screening test (FIT or colonoscopy) that they would like to receive. After watching the video, subjects can choose a CRC screening test. Their primary care provider at the FQHC orders the appropriate test and, where indicated, refers the subjects to a colonoscopy. Subjects who request FIT screening and subjects who do not select any test receive a FIT mailed to their home address. The primary outcome of interest is CRC screening completion within 6 months after randomization as assessed by EHR chart review. A completed screening is any of the following: colonoscopy completion (regardless of indication); 2) at least one FIT test with a normal result; or diagnostic colonoscopy following an abnormal FIT result. We hypothesize that we will observe a higher CRC screening completion rate in the Mobile Health Decision Support intervention arm (Arm 2). This study includes up to three annual rounds of screening eligibility assessment and outreach. Repeated intervention rounds allow us to evaluate whether the intervention can improve adherence to USPSTF recommendations over time. During the 3-year intervention phase, Arm 1 receives usual care only.
Chronic pain affects over 20% U.S. adults and has debilitating effects on quality of life and physical and mental health. Individuals living in rural communities experience higher rates of chronic pain as well as poorer health outcomes due to pain. The 46 million Americans who live in rural areas frequently lack access to evidence-based, non-pharmacologic treatments for chronic pain. As such, a critical need exists to implement effective, comprehensive programs for pain management that include treatment options other than medications. Nurse care management (NCM) has been successfully used to enhance care for individuals with other long-term health issues. The study teams proposes to adapt, pilot, and implement a NCM model that includes care coordination, cognitive behavioral therapy (CBT), and referrals to a remotely delivered exercise program for rural patients with chronic pain.
This project will conduct a pilot hybrid study that examines the implementation (Aims 1 \& 2) and preliminary effectiveness (Aim 3) of PREVENT, a digital health intervention, among patients with overweight/obesity (N=100) using a clinic-randomized design. The central hypothesis of the study is that PREVENT will be feasible and show improvements in health behavior counseling and the patient experience that will improve patients' motivation to change, and their CVH health behaviors and outcomes.
Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement.
The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is: • What is the effectiveness of community resource information on patient self-efficacy to use community resources? Participants will be given: * A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code. * Access to a community resource navigator for support with using the HealtheRx upon request * 2 text messages with reminders about the HealtheRx and access to the community resource navigator
This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. This iteration will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.
The proposed project will implement and evaluate a brief Community Health Worker (CHW) intervention through the Albany Area Primary Health Care, a rural Federally Qualified Health Center (FQHC). The primary goal of this study is to maximize effective outreach, education, and communication through CHWs in order to facilitate improved COVID-19 vaccine confidence and uptake in underserved and vulnerable communities. CHWs will be deployed to the homes of adults with increased risk of morbidity and mortality (i.e., African Americans or Latinos with uncontrolled diabetes or prediabetes, age \<50 years, and non-COVID-19 vaccinated) in order to educate them about diabetes, COVID-19 and related vaccines. Health assessments, including blood glucose measurement, will be conducted on the indexed patient and offered to all other adult family members in the household (i.e., "bubble"). Adults with Type 2 diabetes likely live in households with other adults who have or are at increased risk for diabetes (i.e., prediabetes and obesity).1 It is expected that they will also share similar COVID-19 exposure risk. The specific aims are to: 1) Evaluate a community-driven education program to increase and enhance COVID-19 vaccine confidence and uptake in individuals with uncontrolled diabetes and their families (i.e., their "bubble") and 2) Evaluate a community-driven education program to improve diabetes self-management behaviors and related outcomes (e.g., blood glucose) in individuals with uncontrolled diabetes in rural, Southwest Georgia.
The study team proposes a multi-level trial to test 1) novel implementation programs in rural counties designed to increase access to 2) recent advances in tobacco control services for people who are not-yet-ready-to-quit smoking. In this field, most trials have focused only on those already ready-to-quit. Thus, the proposed trial addresses an important knowledge gap critical to advance tobacco control in rural areas.
The purpose of this study is to implement and evaluate the recently developed Iowa Cancer Affiliate Network (ICAN) intervention. The ICAN intervention will consist of members of the research team providing ongoing support to participating hospitals in achieving the quality standards outlined by the American College of Surgeons Commission on Cancer (CoC). Support will be offered in the form of education and training regarding the standards and provision of cancer services, regular in-person and zoom check-ins with hospital stakeholders to evaluate progress, and provision of documentation and educational resources regarding standard requirements. Implementation approach:1) Engage implementation teams and develop and execute implementation plans based on hospital needs assessments; and 2) Conduct interviews with key ICAN stakeholders to assess acceptability, adoption, appropriateness and cost (based on Proctor's implementation outcomes framework) and determinants of these outcomes (e.g., hospital structure, culture, resources, capacity, readiness) based on the Consolidated Framework for Implementation Research. Evaluation approach: Using Iowa Cancer Registry data routinely collected for surveillance purposes, the investigators will compare rates of compliance with pre- and post-intervention treatment-related quality measures in target and control hospitals. The rural hospitals in Iowa that serve the most rural cancer patients and have never been accredited by the CoC were chosen for intervention targets, and all committed to participating in the study (letters of support provided). The remainder of rural hospitals that care for \>100 newly diagnosed cancer patients per year (n=5) were chosen as a comparison group. The investigators will use data routinely collected by the Iowa Cancer Registry to compare aggregate compliance with quality measures for cancer care between the hospitals included in the intervention and comparison group hospitals using a difference-in-difference estimator. In addition, the investigators will conduct interviews with representatives from intervention hospitals to assess the extent to which ICAN hospitals implemented the CoC standards of cancer care.
Up to 150 individuals with current hepatitis C (HCV) will be recruited from mobile health clinics in rural South Carolina - sites will be selected based on HCV prevalence rates and lack of current HCV screening/treatment resources. NPs will provide HCV care through mobile health units. Participants will be randomized (1:1) to either mobile health clinic treatment as usual or virtual care coordination. Virtual care coordination designed to move people along HCV care cascade will be conducted by the Emocha smartphone platform - an adaptable platform designed by emocha to link patients to care. Using quantitative methods, associations between psychosocial factors such as homelessness, mental illness, provider mistrust, poor social support, high levels of shame and stigma with HCV outcomes including SVR will be examined. Investigators hypothesize that SVR rate among the HCV-infected individuals treated (and with follow-up SVR determination) will be 90% with the Clopper-Pearson 95% CI having a width of 13%.