228 Clinical Trials for Various Conditions
Diabetes mellitus (DM) is a global public health concern. In the United States, adult Hispanic males are particularly vulnerable to type 2 diabetes mellitus and are more likely to develop complications and subsequently die from it, compared to non-Hispanic White males. Evidence suggests good self-management behaviors can potentially prevent disease-related complications and improve clinical outcomes. The American Diabetes Association and Association of Diabetes Care and Education Specialists have endorsed diabetes self-management education as a necessary component of care for all individuals living with the disease. However, adult Hispanic males with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S., especially those who are underserved, typically lack access to formal diabetes self-management education (DSME). Further, the majority have never participated in such educational activities (Au et al., 2021; New Jersey Department of Health, 2013; 2017; 2023). A large body of evidence suggests DSME can effectively improve self-management behaviors in diverse populations around the globe (Abraham et al., 2020; Dietz et al., 2022; ElGerges, 2020; Gehlawat et al., 2019; Hailu et al., 2019; Jiang et al., 2022; Leong et al., 2022; Oluchina, 2022; Riangkam et al., 2022; Tamiru et al., 2023; Yu et al., 2022; Zheng et al., 2019). The purpose of the proposed study is to examine the effect of culturally tailored diabetes education on self-management behaviors of adult Hispanic males, aged 18-64 years, with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S. This study can shed more light on the effectiveness of community-based, culturally tailored diabetes educational activities in this vulnerable population and guide future efforts towards enhancing self-management.
This study will assess the feasibility and preliminary efficacy of a 10-week intervention called "Deaf Diabetes Can Together".
The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.
The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D). The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps.
This study will test the preliminary efficacy of a nurse case-manager, telephone-delivered intervention that provides diabetes self-management education and skills training and resolves the unmet social needs of older African Americans with poorly controlled type 2 diabetes by randomizing 100 African Americans aged 50 years and older with poorly controlled type 2 diabetes to the Combined Diabetes Education/Skills Training and Social Needs Resolution (DM Social Needs) Intervention (n=50) and usual care (n=50) arms. The aims of this study are: Aim 1: Test the preliminary efficacy of the DM Social Needs intervention on clinical outcomes in older AAs with uncontrolled type 2 diabetes. Aim 2: Test the preliminary efficacy of the DM Social Needs intervention on patient reported outcomes in older AAs with uncontrolled type 2 diabetes.
The goal of this clinical trial is to evaluate the use and effectiveness of a mobile web application (app) that is designed to educate and allow patients to manage diabetes and make sustainable lifestyle changes, and to study the impact of the app on clinical outcomes of diabetes (HA1C) and educational outcomes (Self-Efficacy for Diabetes Scale). The main question to answer is: Does the use of the Diabetes Application significantly affect clinical outcomes of diabetes and cardiometabolic risk factors (BMI and Blood Pressure)? Patients will be enrolled in one of two available arms of the study. Participants in the 'intervention arm' will use the app to view educational information presented as videos in the following areas: Healthy Coping, Healthy Eating, Staying Active, Medications (Use and Safety), Problem Solving in Diabetes and Disease Pathophysiology. They will continue routine follow-up care with their primary care physicians during the study. Participants in the 'control arm' will continue with their primary care physician in routine follow-up care, as normally scheduled. Researchers will compare the intervention arm participants to the control arm participants to find out about and compare changes in HA1C, systolic blood pressure, diastolic blood pressure, and body mass index. Groups will also be compared on the basis of self-perceived confidence of managing their diabetes by way of the Diabetes Self Efficacy Scale.
Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.
A 3-step project is proposed. Step 1 will test which BPA time point(s) maximize referral rates to DSMES services in the real world clinic setting (Aim 1). Step 2 will utilize that approach within a pilot study of six sites, comparing the effectiveness of peer support to improve attendance to DSMES services (Aim 2). Step 3 will engage stakeholders in designing a future large scale DSMES services trial to improve referral and attendance to DSMES classes.
Adolescence presents a challenging time for type 1 diabetes management, and despite a multitude of studies aimed at increasing disease compliance in this age group, none have been deemed superior. The purpose of this study is to incorporate mindfulness skills in with diabetes education sessions for adolescents with type 1 diabetes and study if this translates to improved outcomes in glycemic control, patient satisfaction, and mental wellness.
The goal of this study is to examine the efficacy of the video-based Diabetes Prevention Program (DPP) + Community-supported agriculture (CSA) (hereafter INCLUDE) intervention compared with a wait-list control group (hereafter CONTROL) on diabetes prevention among Chinese immigrants with T2D in NYC. Participants will be randomized with equal allocation to one of the two groups. The INCLUDE group will receive one culturally tailored DPP brief video/week for 24 weeks delivered via WeChat. They will also have access to the CSA program that Co-I Dr. Stella Yi has built in existing and ongoing community-partnered work in Brooklyn Chinatown. The CONTROL group will continue to receive their usual care and, at the end of the study, they will receive DPP videos. Measurements will occur at baseline, 3, and 6 months. This study will provide critical information on whether it is efficacious to use an existing social media platform plus CSA support to enhance access to DPP. If the intervention is proven efficacious, this project can provide important data for future scaling of this intervention. This study may serve as a transformative new model to enhance access to culturally tailored diabetes education and promote health equity for underserved limited English proficiency (LEP) immigrant and minority groups.
Determine the impact of the Compañeros en Salud (Partners in Health) curriculum in conjunction with RT-CGM on glycemic control in Latinx patients with T2D. Participants will be randomized to receive the Companeros en Salud diabetes self-management education and support (DSMES) intervention with or without RT-CGM
The proposed study will use a randomized clinical trial design with non-equivalent control group and longitudinal design to evaluate the feasibility, acceptability, and preliminary effects of the Diabetes LIVE JustICE application. The design will incorporate repeated measures at 0, 6, and 12 weeks. Outcome variables will include recruitment assessments, participation, engagement, user experience, and measures proximally related to behavior change - e.g., diabetes knowledge, diabetes-related distress, diabetes self-care, and social support and clinical outcomes -e.g., glycemic control. Focus group interviewing will be conducted to evaluate acceptability among intervention group participants.
Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in adults with type 2 diabetes and elevated diabetes distress who receive care within safety-net healthcare systems in order to assess feasibility and acceptability.
This is a pragmatic, pilot randomized controlled trial (RCT) of the Nutrition-Supported Diabetes Education Program (NU-DSMP). This study will test the feasibility and preliminary impact of providing diabetes-tailored food support and individualized case-management on glycemic control and other intermediate outcomes including food security, diet, mental health, and health care behaviors, among Medicaid-enrolled patients with type 2 diabetes in a safety-net county health system.
Sleep problems are associated with poor blood glucose control, but current diabetes self-management programs do not include sleep education. This study will randomize participants into two groups: one that receives sleep education and one that does not. The researchers expect both groups to experience reductions in blood glucose. The researchers hypothesize that individuals who receive sleep education as part of their diabetes self-management training will experience greater improvements in blood glucose control, as measured by hemoglobin A1c, compared to the control group.
This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support (DSME/S) for African American/Black adults with type 2 diabetes living in Detroit. Participants will be randomized to either a control group or the virtual DSME/S group.
ASL-ADE will evaluate the efficacy of an ASL-interpreted diabetes educational intervention to the end of improving the health literacy of the target population and addressing their disparate health outcomes.
The investigators plan an R33 phase trial in which 120 persons with type 2 diabetes (T2DM) will be randomized (using a 1:1 ratio) to education alone (Ed) on following a carbohydrate restricted diet for T2DM, or this same education content with added mindful eating/Mindfulness-Based Intervention components (Ed+MBI).
The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support (I-DSMES).
The proposed study has been developed to evaluate patient, physician, and provider (educator) centered barriers to and facilitators for engaging in the Diabetes Self Management Education and Support (DSMES) and developing a patient-centered, physician supported DSMES program that could potentially address barriers shared by the patients and their healthcare professionals (Phase 1). The feasibility and efficacy of the newly developed program will be evaluated with an ethnically diverse cohort of 90 patients with type 2 diabetes (30 Caucasians, Asians, and Hispanics each) (Phase 2). A variety of outcomes including clinical, behavioral and psycho-social measures will be used to assess program acceptability and effectiveness.
Diabetes during pregnancy is a challenging clinical situation requiring substantial patient engagement. The investigators have developed a novel early-phase tool, called SweetMama, that incorporates educational, motivational and supportive elements to positively impact maternal health behaviors. This phase of work involves develop an optimized version of SweetMama via a 2-step sequential process of in-depth usability and feasibility testing. First the investigators will conduct focus groups and individual usability testing followed by refinement of SweetMama based on participant input. Next, the investigators will conduct feasibility testing via a pilot randomized trial to determine acceptability, feasibility, and pilot procedures for a fully powered larger trial.
Type 2 diabetes mellitus (T2DM) is the most expensive chronic disease in the U.S. Lifestyle modification is central to T2DM management, but long-term adherence to dietary recommendations is difficult. A key challenge is the difficulty of coping with cravings for high carbohydrate or sugar-laden foods in an environment where these foods are tempting and widely available. One mechanism by which mindfulness may increase long-term dietary adherence is by better equipping individuals with skills to experience food cravings and difficult emotions without eating in response. Such approaches seek to strengthen abilities to be non-judgmentally aware of, tolerate, and respond skillfully to food cravings and difficult emotions without reacting impulsively or maladaptively. The investigators hypothesize that improved ability to manage food cravings and emotional eating is a key mechanism through which mindfulness-enhancements can improve dietary adherence. The study will test a mindfulness-based intervention (MBI) for improving dietary adherence. Although the particular diet employed is not the focus of this study, the study will use a diet with about 10% of calories from carbohydrate as: (1) it induces a low level of ketone production, which will be used as a biomarker for dietary adherence; (2) prior studies suggest it improves metabolic parameters in T2DM, including glycemic control.
The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.
The purpose of this study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist's office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.
The purpose of this study is to to develop and evaluate the feasibility, usability, and effect of participation in SLIDES (a virtual diabetes community in Second Life) for providing interactive diabetes education, support, and resources.
Latinos with diabetes who are attending the Emory Latino Diabetes education program will be approached about consenting to have clinical measurements collected to assess changes between baseline and monthly follow up sessions. The no-cost educational sessions follow the self-care behavior curriculum of the American Association of Diabetes Educators (AADE).
Patients will be recruited from comparable inpatient units that have been randomized as either interventional (Group 1) or control (Group 2) units. Patients in the interventional group will receive a comprehensive individualized diabetes education program coordinated by a certified diabetes educator. Patients in Group 2 will receive education from clinical staff as it is typically provided. Assessment of patient satisfaction with both inpatient and outpatient care, quality of life, and diabetes self-management skills (including emergency room visits and readmissions) will be measured using surveys completed during hospitalization and 4 months after discharge to determine any differences between the two groups.
The study is intended to determine the effectiveness and efficiency of a community diabetes education program administered by a community health worker in a low-cost community clinic. We expect an improvement in overall glycemic control in the experimental group of at least 20%. We also expect to document improvement in diabetes self-management skills, quality of life and an increase in achievement of ADA standards of care4 in the experimental group.
This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.
The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D): * The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies. * The second aim is to evaluate the effects of the Continuous Glucose Monitoring Academy metrics. * The third aim is to explore the relationships between these metrics with diabetes distress, diabetes family responsibilities, and process metrics. Participants will join for a total of four weeks of education, followed by a six-month clinical review. They will have access to an online workbook and videos, and will participate in virtual sessions with a diabetes educator who will cover glucose management strategies in-depth. Participants will wear their preferred Continuous Glucose Monitoring system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.