Treatment Trials

8 Clinical Trials for Various Conditions

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COMPLETED
Facilitating COVID-19 Test for Korean Americans Through Korean Schools in Northern California
Description

In collaboration with Korean Schools of Northern California, the investigators will test if a community-based intervention delivered by lay health educators (LHEs) increases testing uptake among Korean Americans. A pilot cluster randomized controlled trial (RCT) with 300 participants from about 12 Korean Schools will be conducted to evaluate the efficacy of the LHE-led intervention in promoting COVID-19 testing. Participating schools will recruit Korean Schoolteachers as LHEs. According to the group assignment of schools where participants are recruited, the LHE group participants will receive 1) LHE outreach/support, 2) COVID-19 at-home antigen test kits, and 3) the instruction to use the kit while the control group participants will receive test kits and the instruction. Participants will complete an online survey at baseline, weeks 4, and 8. The primary outcome is the COVID-19 testing receipt. The secondary outcomes are intention to get tested, perceived accuracy, benefits and risks of testing, perceived barriers to testing, understanding of negative or positive results, and family members' testing receipt.

COMPLETED
Development of Discharge Education Video for Solid Organ Transplant Recipients
Description

Audiovisual teaching aids can play a significant role for the retention of new material and help overcome barriers such as the physical presence or time restrictions of an instructor. In a clinical setting, multimedia health education can offer an advantage over traditional didactic teaching by engaging patients through visual content and unlimited accessibility. A critical factor to long-term survival of solid organ transplant recipients is compliance to post-transplantation medication and follow-up patient care. Transplant pharmacists serve on multidisciplinary care teams as the medication experts that provide discharge education to recipients and caregivers often at the bedside. The adoption of digital multimedia content for patient education can increase engagement of diverse learning styles while simultaneously reducing potential time conflicts in hospital practice. This study contributes to the literature by assessing the effectiveness of discharge education video(s) on patient satisfaction and knowledge levels which are currently limited.

COMPLETED
Getting Asian Americans INFORMED to Facilitate COVID-19 Testing and Vaccination
Description

This study develops and evaluates the "INdividual and Family-Oriented Responsive Messaging EDucation" (INFORMED) intervention in increasing knowledge about COVID-19 testing and decreasing decisional conflicts of getting tested for COVID-19. A 2-arm randomized controlled trial will compare INFORMED delivered by LHW educational outreach plus Short Message Service (SMS) text messaging to SMS text with LHW support.

ACTIVE_NOT_RECRUITING
Brain Research Apprenticeships in New York at Columbia
Description

The objective of the BRAINYAC program is to prepare high school students for, and deliver, the experience of working in a neuroscience research laboratory over a summer. Our program goals are to prepare local students from Upper Manhattan and the South Bronx with the skills necessary to enter a working research laboratory over a period of 8 months, and support them in learning key laboratory skills and communicating them to an audience.Our hypothesis is that students' self-reports of scientific effectiveness and science identity will improve over the course of the 8-month long program. Self-reported efficacy measures predict academic performance in science, so an improvement in these self-report measures may indicate a higher likelihood to succeed in science, technology, engineering and math (STEM) studies or careers. Likewise, science identity has a positive impact on a student's likelihood of entering a science career, particularly in populations that are under-represented in science.Over a 4-year period we will track students' self-reports of (1) scientific efficacy, including their level of confidence in scientific writing, oral presentation, library and literature search, conducting research and general academic skills, and (2) science identity. We will adopt a mixed-methods approach combining survey data with focus groups and interviews to present a full picture of these changes. We also propose to track students after they leave the program, to measure whether the changes in scientific self-efficacy translate into STEM studies at the level of higher education or career choices. We will also obtain data from scientific mentors in the program to inform us whether we are adequately supporting them in providing the students with training.

TERMINATED
Effects of Dance Practice in Elementary Students
Description

The purpose of this study is to assess changes in benchmark and state assessment scores in a public elementary school following an intervention of dance integration into the daily routine of the classroom. Furthermore, this study aims to assess if dance may improve student behavior, teacher perception of student behavior, reading level and attendance.

COMPLETED
Parent Educational Discharge Support Strategies
Description

After the initial hospitalization, parents of children newly diagnosed with cancer assume responsibility for assessing and managing their care; however, parents are often overwhelmed with information received throughout the hospitalization and are apprehensive about caring for their child at home. Parents want concise, focused information on how to care for their child after the hospital discharge. Two parent education discharge support strategies (PEDSS) were created to use at hospital discharge. PEDSS consists of a symptom management intervention and a support for the caregiver intervention. A cluster randomized control trial will assess the effectiveness and feasibility of the two different interventions.

COMPLETED
Evidence-based Educational Materials and Local Resources for Improving Exercise-related Outcomes During Pregnancy
Description

Despite the well-established benefits of physical activity, only 23% of pregnant women report exercising in accordance with guidelines recommended by the American Congress of Obstetricians and Gynecologists. Further, pregnant women report receiving little or no advice about physical activity during pregnancy from their health care provider; thus, the scientific evidence supporting physical activity during pregnancy does not appear to be translating into the clinic and the community. The goal of this project is to determine if the distribution of evidence-based educational materials and local resources will increase knowledge regarding the benefits of physical activity during pregnancy, patient-provider communication about physical activity during pregnancy, and physical activity levels during pregnancy. Hypothesis A: Pregnant women who receive evidence-based educational materials and local resources will have increased knowledge regarding the benefits of physical activity during pregnancy. Hypothesis B: Pregnant women who receive evidence-based educational materials and local resources will have more communication with their health care provider about physical activity. Hypothesis C: Pregnant women who receive educational information and local resources will report increased physical activity levels. Hypothesis D: Pregnant women who receive evidence-based educational materials and local resources will have improved pregnancy outcomes including lower gestational weight gain, lower insulin resistance (as determined by their clinical oral glucose tolerance test), and healthier neonatal birthweight.

COMPLETED
Intensive Models of HCV Care for Injection Drug Users
Description

Injection drug users (IDUs) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). HCV treatment leading to sustained viral response (SVR) is associated with increased survival. However, IDUs have had poor access to HCV care and their success in HCV treatment has been limited. With direct-acting antiviral agents, HCV treatment delivered within large clinical trials leads to SVR or cure in over 70% of genotype-1 infected patients, compared to 45% with previous therapies. However, SVR rates are as low as 14% in real-world settings. The majority of patients who fail to achieve SVR will develop drug resistance, but the optimal adherence level to minimize resistance is unknown. If HCV treatment continues to be delivered within current models of care, most IDUs will not only fail treatment and develop resistance, but may transmit resistant viruses to others. We have previously developed a multidisciplinary model of HCV care which integrates on-site primary care, substance abuse treatment, psychiatric care, and HCV-related care within opiate agonist treatment clinics. To maximize treatment outcomes, we piloted two models of intensive HCV-related care: directly observed therapy (DOT), and concurrent group therapy (CGT). In our DOT model, pegylated interferon is administered once weekly, if applicable, and one daily dose of oral medication is administered at the methadone window. In our CGT model, patients initiate HCV treatment within a once weekly treatment group which provides powerful social support to mitigate fears of side effects, promote efficient education, and deliver weekly injections, if applicable. It is unknown whether either model is better or more cost-effective than standard on-site care. PREVAIL 1: In the proposed study, 150 IDUs with chronic HCV (genotype 1) will be recruited from methadone clinics and randomized to one of three models of care: DOT; concurrent group treatment; or standard on-site care. Our specific aims are: 1) To determine whether either of two intensive on-site HCV treatment models (DOT or concurrent group treatment) is more efficacious than standard on-site treatment for enhancing adherence and SVR, and decreasing drug resistance; (2) To determine the incidence and factors associated with the development of drug resistance in IDUs; (3) To perform cost and cost-effectiveness analyses of each model; (4) To examine the impact of HIV coinfection on adherence and virologic outcomes among HCV-infected IDUs. PREVAIL 2: In the proposed study, 60 IDUs with chronic HCV (genotypes 1 2, 3 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with sofosbuvir-based regimens and (2) to determine adherence rates over time in drug users (genotype 3 and genotype 1 / IFN-ineligible) initiating a 24 week IFN-free regimen. PREVAIL 3: In the proposed study, 60 IDUs with chronic HCV (genotype 1 and 4) will be recruited from opiate agonist treatment programs and started on HCV treatment. Subjects will be offered the choice of model of care (either standard on-site, DOT, or concurrent group treatment). Our specific aims are: (1) to determine rates of adherence and SVR in a cohort of opiate agonist treatment patients initiating treatment with oral DAA combination of sofosbuvir and simeprevir or fixed dose of sofosbuvir and ledipasvir and (2) to determine adherence rates over time in drug users.