Treatment Trials

112 Clinical Trials for Various Conditions

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COMPLETED
Transgender Health: an Educational RCT
Description

The investigators will conduct a randomized controlled trial (RCT) comparing two different educational approaches on the healthcare of transgender and gender expansive (TGE) youth. Finding best practices to educate healthcare providers and the community at large stand to make an impact on the mental health of TGE youth by helping them feel more welcome and better understood by the communities in which they live. The study aims are to evaluate two educational interventions: 1) The inclusion of a video clip component of two TGE youth (Video \[V\] vs No video \[N\]) into a one-hour didactic; and 2) The delivery of the same didactic content by a cis- \[C\] vs a trans-gender \[TG\] woman.

RECRUITING
Testing the Causal Effects of a Civic Engagement Intervention on Health and Wellbeing Among Youth (I-ACTED)
Description

The purpose of this research is to understand how participating or not participating in an action civics curriculum may affect the health and wellbeing of young people. Participants will be chosen from students who attend certain schools that choose to participate in the action civics curriculum. Participation in this research involves completing surveys during class time in the Spring and Fall 2021-2022 semesters and then completing online surveys outside of class in the future.

COMPLETED
Survey on Precision Medicine and Digital Health
Description

The investigators have created an anonymous online survey that queries current topics in precision medicine.

COMPLETED
Pilot Evaluation of an Interactive Health Game
Description

Broad, diverse, and innovative efforts are needed to address the growing dual public health challenges of obesity and diabetes, especially for those at increased risk like minority older adults. The emerging field of health games offers an innovative opportunity to reach populations to provide healthy eating and physical activity messages. Little research has focused on the use of health games specifically tailored for older adults. This study builds upon a health game designed to provide knowledge, facilitate movement, enhance motivation, and encourage healthy eating (HE) and physical activity (PA) behaviors in youth. This study will adapt, implement, and evaluate the feasibility, acceptability, adherence, and preliminary outcomes of the game among overweight/obese African American older adults.

COMPLETED
Encouraging LPG Adoption in Ghana: A Factorial Randomized Clinical Trial to Enhance LPG Adoption & Sustained Use
Description

Household air pollution (HAP) is a top-priority public health problem in developing countries. According to the most recent comparative risk assessment, 3.5 million people die prematurely each year as a result of HAP exposures. While uncertainties remain regarding causal links between HAP exposures and health, the time is ripe for focused research into effective interventions. Limited past research has shown that the demand for clean cookstoves is low, and that households continue to use traditional hearths even when they have clean stoves. The investigators propose to harness an existing cohort in Ghana to study factors that increase the adoption of clean cookstoves, and to test strategies to promote adoption and continued use.

COMPLETED
Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
Description

This is a randomized clinical trial to test the efficacy of a parent-targeted text message-based intervention program on caries incidence and oral health behaviors (child and parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or TMs regarding child wellness. The study will enroll English and Spanish speaking parents and their youngest child who is \< 7 years old, has at least one tooth showing, and attends the targeted pediatric clinic to receive primary care (n= 1700). Parents will complete self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and respond to TM assessments during the 4-month intervention; and will also receive TMs during a 'booster' period of one month, which will occur 12-months post baseline. Parent's children will be assessed for caries by a clinical oral examination performed by licensed Clinical Examiners at baseline, 12-and-24-months post-baseline.

ACTIVE_NOT_RECRUITING
Improving Healthy Living Opportunities: Laurel HARVEST
Description

The goal of this pre-post intervention study is to understand how community-engaged approaches to policy, systems, and environmental approaches can work to improve fruit and vegetable consumption and food security status among an Appalachian Kentucky community. The main approaches taken will be to employ a Community Advisory Board to define our target population of need, and appropriate intervention strategies. The investigators aim to understand if nutrition-based programming and food system approaches for lower-income, single-parent households, and multi-generational households can improve health. Participants will engage in annual data collection to assess dietary quality and food security status.

RECRUITING
Culturally Tailored HPV Psychoeducational Multimedia Intervention
Description

Community members ages 18 - 45 years old from the El Paso, Texas, U.S.-Mexico Border Region will be recruited to compare psychoeducational multimedia interventions focused on the human papillomavirus (HPV). Our hypothesis is that adults who view culturally tailored multimedia stories encouraging HPV vaccination will report higher vaccine uptake rates.

COMPLETED
Impacts of Clinician-Mediated Report-Back
Description

The study trains clinicians to return personal exposure results to study participants in pregnancy cohorts, and measures outcomes for environmental health literacy for both clinicians and study participants.

RECRUITING
Doulas as Environmental Educators and Partners Study
Description

The aims of this project are: Aim 1: Determine the extent to which an environmental health literacy educational intervention designed for doulas improves their environmental health literacy of endocrine disrupting chemicals (EDCs) in personal care products. Hypothesis 1a. Doulas who participate in an environmental health literacy course will have a higher environmental health literacy score based on quantitative questionnaire evaluation post-course compared to pre-course. Hypothesis 1b. Doulas who participate in the environmental health literacy course will have a higher environmental health literacy scores post-course compared to doulas who do not take the environmental health literacy course. Aim 2: Determine the extent to which pregnant people counseled by doulas with training in environmental health literacy have higher environmental health literacy scores and lower usage of personal care products containing EDCs following doula counseling. Hypothesis 2a. Compared to pregnant people not counseled by doulas on EDCs in personal care products, pregnant individuals counseled by doulas on these EDCs will have improved scores in environmental health literacy. Hypothesis 2b. Compared to pregnant people not counseled by doulas on EDCs in personal care products, pregnant individuals receiving counseling will use fewer personal care products associated with containing EDCs based on a validated questionnaire. Aim 3: Determine whether concentrations of EDC biomarkers decreased after the intervention for the intervention group. Hypothesis 3: Urinary phthalate metabolite concentrations will be lower post-course compared to pre-course for the intervention group.

COMPLETED
Improving Health and Environmental Health Literacy of Professionals
Description

The goal of this clinical trial is to understand the impact of an educational intervention on reproductive health care providers' environmental health literacy related to phthalates. The main questions to answer are: 1. Does a web-based educational intervention improve the environmental health literacy of personal care product chemicals based on pre/post/post intervention survey data? 2. Does a web-based educational intervention improve reproductive health professionals' confidence and awareness for communication to patients on environmental health literacy? 3. Do concentrations of personal care product chemicals in reproductive health professionals decrease after the web-based educational intervention? Participants will be asked to complete three surveys: one before the educational intervention, and two after the intervention. The will be asked to complete the approximately 1-hour online educational intervention, which consists of a series of videos from the perspectives of patients, OBGYNs, and researchers, an interactive module, and a worksheet to facilitate conversation with patients.

COMPLETED
Easy Peasy: Health Effects of Supplementation With Vegetables
Description

The proposed study aims to test the effects of supplementing healthy individuals (with low baseline vegetable consumption) with 5 servings of vegetables (80-120g per serving) per day for 4 weeks on blood lipids and other cardiometabolic outcomes. Previous studies indicate the potential to see significant effects in this population and within this amount of time. Importantly, the investigators will also be including a weekly cooking demonstration as part of the intervention, which provides an essential hands-on participatory component and allows participants to connect with one another in a group setting, which aids in acceptability and adherence to dietary interventions. The investigators hypothesize that 4 weeks of daily supplementation with 4-5 servings of vegetables will significantly improve LDL-C and other cardiometabolic outcomes in healthy adults.

COMPLETED
Impact, Feasibility, and Acceptability of Bladder Basics
Description

PLUTS remains a common childhood condition despite effective treatment options. It is important to improve delivery of UT at the clinical level, with future studies that shift pediatric bladder health into a broader community context. This change in contextual setting and scale can impact access to care and disease incidence beyond our current treatment paradigms. Therefore, the overall objective is to measure the early impact and feasibility of a digital health intervention, Bladder Basics. To complete this aim, we will measure clinical and education outcomes pre- and post- intervention and our assessment of acceptability and feasibility will consider framework-based barriers to implementation. Since there is limited existing data with which to build a future intervention, these variables have been carefully considered based on requirements for a future school-based intervention

COMPLETED
A Study Investigating the Effects of a Novel Mindfulness Approach on Frequency and Duration of Meditation and Self-Reported Stress and Mood in Generally Healthy Adults
Description

The goal of this clinical trial is to compare the frequency and duration of meditation in generally healthy adults between: 1. A novel approach to mindfulness meditation encompassing guided tea consumption 2. Breathing meditation Participants will be encouraged to meditate every day in either way listed above and asked to complete Daily Study Intervention Recall for 8 weeks. Additionally, self-reported aspects of stress and mood will be evaluated.

RECRUITING
Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention
Description

Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

COMPLETED
Shared Decision-making on Medical Tests and Care Cascades
Description

The purpose of this randomized controlled trial is to evaluate the impact of patient and provider facing educational materials and peer comparison on medical testing conversations during annual physicals. The investigators hypothesize that education materials and peer comparison will improve conversation quality about medical testing decisions.

COMPLETED
Feasibility and Acceptability of a Chaplain-Led Post-Code Debrief Intervention
Description

The objective of this study is to increase the frequency and effectiveness of post code debriefs by piloting a novel intervention tool and partnering clinicians with board certified chaplains trained to facilitate group processes. A post code debrief will involve two aspects: a technical debrief (a discussion to process the technical, procedural aspects of a medical code/cardiopulmonary arrest), which will be led by a clinician, and an emotional debrief (a discussion to process the emotional, existential impact of a medical code/cardiopulmonary arrest), which will be led by a chaplain.

ACTIVE_NOT_RECRUITING
Improving Health Awareness Using Social Network Interventions
Description

The overarching hypothesis of our study is that social network interventions using artificial intelligence and social media can be used to increase population awareness about health issues. The overarching objective is to improve population awareness on multiple relevant health issues using social network interventions (SNI) and estimate the effect by conducting randomized control trials. Increase population awareness about organ donation in California, especially among minorities

COMPLETED
Improving Health Insurance Literacy Among Utah's Hispanic Population
Description

This is a test of an existing health insurance education program (HIEP) in the Utah Hispanic community (aged 18-64). The study will evaluate whether the HIEP delivered by Utah Health Policy Project (UHPP) staff improves participants' health insurance and cost-related literacy. Participants will complete a brief baseline survey, be guided through the HIEP by UHPP staff, and complete a brief survey after completing the sessions.

SUSPENDED
PALS for Pap Smear Follow up
Description

In this study, the researchers will utilize information gained from patient interviews about their knowledge of the cervical cancer screening and treatment process, and perceived barriers surrounding appropriate follow up, to create content for the intervention.

COMPLETED
Training for Health Professionals In Tanzania
Description

The goal of this randomized, controlled, single blinded trial is to evaluate the effectiveness of an Afrocentric sexual health curriculum on health professional students' knowledge, attitudes, and clinical skills in providing sexual health care in Tanzania.

COMPLETED
Utilizing Technology to Promote Cancer Prevention
Description

The goal of the program is to develop an online module/a health application for cell phones which will share didactic information regarding cancer prevention and early detection measures. These module/application will be developed, and be tested among volunteers for feedback. In the future, these module/application will be disseminated widely to address cancer health disparity particularly in Arkansas.

COMPLETED
Methods to Improve Preventative Care Uptake
Description

The proposed study examines whether providing patients with information on the incentives for following the preventative care guidelines available through their insurance has an impact on the update of these preventative services.

COMPLETED
Measuring Nutrition Literacy in Clinical Practice: Evaluating Effects Upon Providers and Patients
Description

This study evaluates the effects of assessing patient nutrition literacy prior to an initial session with an outpatient dietitian on the patient-centeredness of the session. We will randomize 6 dietitians, 4 of whom will have access to their participating patients' nutrition literacy scores. These dietitians will use this information to better inform their interventions, and hopefully improve their patients' nutrition literacy as a result.

COMPLETED
Promoting Patient Engagement in Clinical Preventive Services: Evaluating the Use of Healthfinder
Description

Clinical preventive services (CPS) are fundamental to early disease detection and improvement of health outcomes but are often poorly understood and utilized by patients. Myhealthfinder is a web-based tool developed by the Office of Disease Prevention and Health Promotion (https://healthfinder.gov). This study tests the "prescription" of myhealthfinder to engage patients in CPS, improve patient-clinician communication and increase uptake of CPS.

COMPLETED
Parent/Caregiver Conference Attendance Feasibility
Description

This study will assess and evaluate conference attendance feasibility and will gather feedback about preferences and barriers to attendance at the American Society for Nutrition annual conference.

RECRUITING
PCORI-CER-1306-03385 Lung Cancer Screening Decision Aid Development and Testing
Description

Objectives: This protocol addresses the first phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (CT). A separate IRB protocol will be submitted for the larger, comparative study. In this initial development phase, our prototype patient decision aid will be updated to reflect current guidelines about lung cancer screening. The updated aid will then be pilot-tested in a new sample of patients. In addition, several of the study measures will be refined and further developed in preparation for the larger study. The specific aims of the measures and decision aid development phase of this project are as follows: Update the aid to reflect current screening guidelines and refine the aid via cognitive testing with patients/smokers; and pilot test the updated aid for acceptability with patients/smokers. Modify our current measure of lung cancer knowledge, conduct cognitive testing of the new measure with patients/smokers, and evaluate the reliability of the new measure in a sample patients/smokers.

COMPLETED
Integrative Health Coaching in Community Settings
Description

This study examines a pilot project to introduce integrative health coaching to two community clinical sites, Healing with CAARE Inc. and the Healthy Lifestyles program at Duke Pediatrics. 10 participants and 10 controls will be referred for enrollment at each site (n=20 per site) by on-site personnel, and 6 coaching sessions will be provided over a 3-month period at no cost by coaching trainees completing their certification hours. Pre and post measurements of BMI, patient activation, and perceived interpersonal support will be collected and analyzed for interaction effects. Qualitative process evaluation will be conducted as a thematic analysis via guided interviews with stakeholders and participants, using the "RE-AIM" framework. Feasibility measures will include recruitment of both coaches and clients, subject/client retention, and number and duration of coaching sessions completed. Finally, a subset of the CAARE Inc. cohort will be consented to participate in a post-intervention focus group that addresses the impact of coaching on perception of health-related resources and needs in the community. Primary Hypotheses: Integrative health coaching will be a feasible intervention in both community and clinical settings, in terms of required resources, patient or client adherence, and satisfaction by community stakeholders, including providers and participants. Additional hypotheses: Individuals who receive integrative health coaching sessions as an adjunct to their standard medical care will see improvements in patient activation and perception of interpersonal supports, when compared to controls. Individuals who receive integrative health coaching (or in the case of the pediatric cohort, children of individuals who receive coaching) will see minor improvements in BMI over the study period when compared to controls.

COMPLETED
The Impact of Community Health Worker Training by US Health Volunteers on the Health of Rural Ugandans
Description

There are many trials measuring the impact of service work on volunteers themselves, but few studies measuring the impact of service on the local people. The purpose of this trial is to determine whether US and Ugandan health volunteers can make a measurable impact on the health of rural Ugandan villagers.

COMPLETED
"Anticipatory Guidance in the Nursery and Its Impact on Non-urgent Emergency Department Visits"
Description

Kennedy et al, in a study of pediatric Emergency Department (ED) use by newborns less than 14 days of age, revealed that half of all visits in this population were non-acute problems. Other pediatric ED utilization studies have shown similar findings in that 32% to 72% of all visits were for non-urgent problems. Many studies have found that primiparity and young maternal age are associated with non-acute ED presentations. A recent factor that has been investigated is the effect of early neonatal discharge. Some other factors are nonwhite mothers and mothers on Medicaid. Zandieh et al, found additional predisposing determinants for non-urgent ED visits, such as single parenthood, Hispanic ethnicity, and having perceptions that their child's overall physical health was poor. Paradis et al found that parents receiving a video intervention rated higher confidence with specific infant care skills and reported feeling better prepared to care for their baby, compared to parents receiving only handouts. However, there isn't any reported study that evaluates the benefits of receiving both, a video intervention along with handouts. Aim: to demonstrate whether conducting anticipatory guidance related to non-urgent problems will reduce non-urgent ED visits, compared to care as usual (CAU) anticipatory guidance (Sudden Infant Death Syndrome and Shaken Baby Syndrome videos; and unstructured talk about jaundice, vaccinations, appointments, care of umbilical stump, normal urination and bowel movement, fever).