462 Clinical Trials for Various Conditions
Background: In 2018, the NIH intramural research program had almost 23,000 people taking part in active clinical research studies. Half of those people were female. More than a third were of child-bearing age. Researchers want to use data from this group to create a pregnancy registry. It will be used to collect data about pregnancy and birth outcomes related to unplanned exposure to research products. These products may include drugs, vaccines, treatments, and interventions. Objective: To collect data about pregnancies and births from people who took part in an NIH clinical trial and their partners who became pregnant while in the study or shortly after. Eligibility: People of any age and their partners who took part in an NIH clinical trial and became pregnant while in the study or within 1 year after. Design: Participants will be screened by phone. Their clinical trial history will be verified. Participants will be interviewed in person, by phone, or virtually. They will be asked about their health and their trial experience in relation to their pregnancy. They will give details about their pregnancy and baby (if appliable). They will be interviewed every 6 months for 1 year after the birth of their baby, as applicable. Data from both NIH and outside medical records will be used. Participants will give their doctor s name and contact details. They will provide a release for their records to be used. If needed, they will provide a release for their baby s records. Data will be coded and stored in a database on an in-house NIH secure server. Data may be used in future studies
The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).
The purpose of this research study is to compare the effect of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). The study is designed to evaluate how well these treatments can help TBI partner caregivers improve approach/avoidance behaviors.
This trial studies the day-to-day stress, social support, and health lifestyle behaviors (such as physical activity and nutrition) in African American patients with stage 0-III prostate cancer survivors and their partners. How patients cope with stress may affect their lifestyle behaviors. This study may help understand not only survivors' behaviors but also partners' behaviors and how they interact.
This pilot clinical trial studies how well acceptance and commitment therapy works in improving well-being in patients with stage III-IV cancer and their partners. Learning how to accept negative thoughts and feelings and how to live in the present without worrying about the future or past may improve coping skills in patients with stage III-IV cancer and their partners.
The purpose of this study is to determine whether female partners of African American men can promote initiation of a discussion with a healthcare provider about prostate cancer screening when the partner is supported by a print message designed to provide relevant information and strategies for her to use in this effort.
Purpose: To compare a novel psychotherapy, Partner-Assisted Interpersonal Psychotherapy (PA-IPT), with treatment as usual (TAU) in a sample of pregnant women seeking treatment for Major Depressive Disorder (MDD) at the University of North Carolina at Chapel Hill (UNC-CH) Perinatal Psychiatry Program. Participants: 52 women, ages 18-45, who are 16-29 weeks pregnant and experiencing a depressive episode, and their partners. Methods: Women and their identified partners will complete a diagnostic interview, complete measures of depressive symptom severity at baseline, and be randomized to treatment with PA-IPT or TAU. Women randomized to TAU will be treated by UNC physicians according to the UNC-CH Perinatal Psychiatry Program's algorithm for treatment of prenatal MDD (usually one of a number of antidepressant medications, tailored to the individual, although some women may opt against medication altogether and still be eligible to enroll). Women randomized to PA-IPT will participate in 8 therapy sessions with their identified partner over a 12-week period, along with one refresher session at or around 6 weeks postpartum. Women and partners will be assessed for change in depressive symptoms and relationship satisfaction during pregnancy at visits 4 and 8, and postpartum at 6-week and 6-month visits. Hypothesis: The investigators anticipate notable improvement in both groups similar in magnitude, however it is hypothesized that couples participating in PA-IPT will have higher relationship satisfaction post-treatment (controlling for baseline satisfaction) than those receiving TAU.
The long-range goal of this research is to develop better ways of helping GI cancer patients and their caregivers cope more effectively with the demands of the disease. The study is designed to test the hypothesis that a partner-assisted emotional disclosure intervention will be more effective in enhancing patient' psychological adjustment than a cancer education condition.
The Shwachman-Diamond Syndrome Global Patient Survey and Collaboration Program (SDS-GPS) is an opportunity for patients and their families - from anywhere in the world - to share their experience living with SDS via a safe, secure, and convenient online platform, to * expand the understanding of SDS * improve the lives of people with SDS, and * accelerate the development of new therapies and cures for SDS. By joining, participants will receive early access to relevant information about new clinical trials and other research opportunities (such as clinical registries) based on their profile, accelerating research and increasing clinical trial impact and recruitment success. The platform, consent forms, and surveys are available in five languages: English, Spanish, French, German, and Italian. More languages to come.
PTSD occurs in up to 17% of post-9/11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. An important minority (\~40%) will retain their PTSD diagnoses after treatment, and many discontinue treatment prematurely, especially post-9/11 Service Members. TFTs are also more effective in addressing symptoms than psychosocial functioning. More work is needed to improve the consistency and potency of TFTs. Partnering with significant others may provide a powerful method for helping individuals get more out of their PTSD treatment. Observational research shows that relationship factors can help patients initiate, stay in, and experience greater benefit from PTSD treatment. Veterans that were surveyed experienced greater treatment gains when they shared more about their treatment with loved ones and when loved ones accommodated less for PTSD symptoms. Despite the promise of partner-involved interventions, there is no couples approach to PTSD treatment that has demonstrated superior outcomes to individual-only treatment models (i.e., TFTs). To address this gap, the investigators have completed a series of partner-assisted PTSD treatment studies, leading up the current proposal (Partnered PE, PPE). The investigators found that treatment completion rates were better than routine clinical care, and the treatment led to large improvements in participants' functioning, PTSD symptoms, and romantic functioning. For this proposed study, the primary objective is to conduct a randomized controlled trial (Research Level 3; larger-scale clinical trial) to test the superiority of PPE to standard PE among post 9/11 Veterans. The investigator's primary hypothesis is that PPE will lead to greater improvements in psychosocial functioning than standard PE. Secondary and tertiary aims examine posttreatment clinical outcomes (PTSD, depression) and intimate partner outcomes (relationship functioning, distress, caregiver burden, and psychosocial functioning), as well as examine strategies for PPE implementation. In exploratory aims, the investigators will examine the stability of group differences, treatment completion rates, the role military sexual trauma history, and treatment mechanisms.
The purpose of this study is to pilot a resiliency and coping intervention for persons recently diagnosed with Amyotrophic Lateral Sclerosis (ALS) and their primary informal caregivers. The data investigators gather in this study will be used to further refine our intervention.
The investigators aim to support care partner's well-being and satisfaction with VA care and decrease their work burden by offering extra support from a trained Community Health Worker who will help connect the care partner to helpful resources in their communities and in the VA. The investigators also hope to help Veterans well-being and satisfaction with VA care by supporting their care partner more sufficiently allowing the care partner to focus on caregiving tasks.
EPICLA+ (Early-Stage Partners in Care Living Alone Plus) is a research project designed to assist people with early-stage memory loss who live alone in the community by providing early-stage related education and skill-training sessions, held via Zoom, designed to reduce stress, enhance well-being, manage challenges, and plan for the future. Researchers will gather feedback from individuals about their experience to continue to improve programs for early-stage memory loss.
The Partnering with Antenatal Navigators to Transform Health in Pregnancy (PATH) study aims to evaluate whether an antenatal patient navigation program improves maternal health, neonatal health, pregnant persons' experiences, and health care utilization outcomes among low-income pregnant individuals and their neonates. Patient navigation is an individualized, barrier-focused, longitudinal, patient-centered intervention that offers support for a defined set of health services. In this randomized controlled trial, pregnant individuals who are randomized to receive antenatal patient navigation will be compared to pregnant individuals who are randomized to receive usual care. Navigators will support birthing people from before 20 weeks of gestation through 2 weeks postpartum. The PATH intervention will be grounded in understanding and addressing social determinants of health in order to promote self-efficacy, enhance access, and sustain long-term engagement. The main objectives of the study are to: 1. Evaluate whether PATH, compared to usual care, improves maternal health outcomes. We hypothesize the PATH model of bundled social- and health systems-focused antenatal patient navigation for racially and ethnically diverse low-income individuals will reduce the incidence of a composite of adverse maternal outcomes all known to be associated with socioeconomic disadvantage and SDoH. We will also investigate maternal health care utilization. 2. Evaluate whether PATH, compared to usual care, improves perinatal health outcomes. We hypothesize PATH will reduce the incidence of a composite of adverse perinatal outcomes. We will also investigate neonatal/pediatric health care utilization. 3. Evaluate patient, clinician, navigator, and healthcare system experiences with PATH in preparation for widespread implementation and dissemination of the PATH obstetric navigation model. This aim will be accomplished through investigating patient-reported outcomes, completing qualitative and process mapping interviews with navigated participants, and completing qualitative and process mapping interviews with clinicians, navigators, and health administrators.
The proposed study will test the feasibility and acceptability of enrolling and retaining cancer survivors and their bedroom partners in a study evaluating digitally delivered behavioral sleep interventions.
The goal of this observational study is to learn the feasibility, acceptability, appropriateness, and adherence to a case management intervention. PartnerED is a case management intervention that aims to reduce unnecessary hospital admissions by providing real-time, structured information and discharge support to emergency department providers via phone and fax. The intervention is led by chronic care managers employed by Bluestone Accountable Care Organization, a physician group primarily serving patients in assisted living centers.
The goal of the EPICC observational study is to learn about capacity to implement evidence-based health promotion programs (EBPs) in congregations that are offered semi-structured technical assistance (TA). Congregational teams will complete an implementation capacity assessment survey before the TA is offered and 10 months later, after TA has been provided for up to 10 months. Participating congregations will be a convenience sample of congregations in Davidson County, TN that serve primarily African American communities.
This randomized controlled trial will take place in up to 15 community health centers across the state of Illinois. Researchers will be studying S.A.F.E. Firearm, a program that aims to increase secure storage of firearms in homes with children. Specifically, S.A.F.E. Firearm includes a brief conversation between pediatric clinicians and parents about secure firearm storage and an offer of a free cable firearm lock within the well-child visit. Researchers will also study a package of strategies to help pediatric clinics incorporate this new practice. The strategies include training for clinic personnel and facilitation, or tailored problem-solving support. The questions the study aims to answer are: * How effective is the package of strategies at helping pediatric clinics adopt this new practice? * How effective is the S.A.F.E. Firearm program at changing parents' and guardians' firearm storage behavior? Some parents and guardians will be invited to complete a brief survey after their visit about their experiences receiving S.A.F.E. Firearm. Some community health center personnel will also be invited to complete an interview about their experiences with S.A.F.E. Firearm and the package of strategies.
This project is designed to have patients participate in a virtual environment with various tasks such as breathing exercises, games to help the brain, and techniques that promote relaxation while hospitalized in the Intensive Care Unit (ICU). The participation in research will last about 5 days and take about 15 to 45 minutes each day.
The goal of this study is to conduct a randomized controlled trial (RCT) comparing outcomes between two programs to reduce intimate partner violence (IPV)- the Strength at Home (SAH) program and a standard, state-approved IPV intervention program, Treatment as Usual (TAU). Primary outcomes will include self- and partner-reported physical and psychological IPV. Secondary outcomes will include self-reported PTSD symptoms, alexithymia, alcohol use problems, and treatment satisfaction, assessed across five time points.
This research study investigates the feasibility and acceptability of a group-based treatment program for reducing stress, trauma, substance use, and use of violence among individuals who were court-mandated to attend a program after committing an act(s) of domestic violence.
Lung cancer is the leading cause of cancer-related death among Veterans with 90% of cases attributable to smoking. Lung cancer screening (LCS) combined with smoking cessation saves the most lives. ICARE-LCS seeks to decrease health inequality and improve Veteran health by reducing smoking rates among Veterans receiving LCS. ICARE-LCS will use implementation methods to inform national cancer prevention efforts and build infrastructure necessary to support broad implementation of high-impact tobacco dependence treatment (TDT) processes in LCS programs.
This study seeks to evaluate the impact of a remote patient monitoring (RPM)-specific tech-enabled community health worker workforce on the use of RPM for the management of hypertension among Latinx patients. This study is a step-wedge randomized controlled trial that aims to assess the effectiveness and implementation of RPM-enabled community health workers (CHWs) compared to standard of care RPM hypertension management on blood pressure reduction and evaluate the implementation of the RPM-enabled CHWs for hypertension (HTN) management. The study aims to examine adoption, acceptability, fidelity, cost, sustainability, and equity as outcomes of implementation effectiveness.
The purpose of this study is to evaluate the impact of a 4-week art therapy intervention on the relationships between individuals diagnosed with Alzheimer's disease and their care partners, on the self-esteem of diagnosed individuals, and on care partner attitudes towards persons with Alzheimer's disease.
The goal of this clinical trial is to learn how well two community-based self-management programs work in people with chronic back or neck pain from populations that have been minoritized based on race, ethnicity, or income. The main question it aims to answer is: How well does a community-based self-management program teaching mind-body skills such as mindfulness and cognitive behavioral approaches (Partners4Pain) work for reducing pain intensity and interference with general activities and enjoyment of life compared to a community-based self-management program focused on general health and wellbeing (Keys to Wellbeing)? Participants will be asked to do the following: * Attend 2 screening visits to learn about the study and see if they meet the requirements to participate. * Be randomly assigned to one of the two community-based self-management programs. * Attend 9 weekly self-management program sessions (90 minutes each) * Complete surveys about their pain and overall health at 2 months (after the programs end), 4 months, and 6 months. Funding for the project is provided through the National Center for Complementary and Integrative Health (NCCIH) and the National Institute of Neurological Disorders and Stroke (NINDS) through the NIH HEAL Initiative (https://heal.nih.gov/), R33AT012309.
According to the Centers for Disease Control and Prevention (CDC), "88,000 people die every year due to alcohol-related issues including homicide, sexual assault, intimate partner violence, and suicide". In the city of Dallas, violent crimes have decreased by roughly 4% in 2022 compared to 2021. Dallas Police Department (DPD) implemented changes in May 2021 to combat violent crimes.
This study conducted a preliminary pilot implementation which integrated our existing social network software - Network Canvas - into Chicago Partner Services in order to understand the feasibility and acceptability of this integration, and to gather preliminary evidence of potential efficacy in improving Partner Services metrics. All of this work will be conducted through an Active Implementation Framework in which we utilized a staged- approach and strong engagement with local (e.g., Chicago Department of Public Health and Howard Brown Health) and national stakeholders to explore, install, and implement a software pilot into Partner Services.
The purpose of this study is to understand how to leverage structures and processes of academic health department (AHD) partnerships to facilitate implementation of cancer related evidence-based programs and policies (EBPPs).
Hoosier Sport is a sport-based youth development program that uses the power of sport to teach children and adolescents sport and leadership skills while promoting health education. Conducted in rural middle and high schools, the program aims to enhance health and wellness by incorporating unique sports such as volleyball and flag football, along with leadership activities like goal setting and health education on the importance of exercise and a healthy lifestyle. The program runs for eight weeks each semester (Fall and Spring), with sessions twice a week during PE class, where college service-learning students lead the curriculum. Data on physical activity and psychosocial factors are collected to assess changes in health, ensuring confidentiality through strict IRB protocols.
The goal of this feasibility study and clinical trial is to learn if an evidenced-based breathwork and meditation intervention (SKY Breath) will improve the mental and physical well-being of individuals with Parkinson's Disease (iPD) in stages 1, 2, and 3, under the age of 75 and their care partners. The main questions it aims to answer are: * Objective 1: Can the SKY Breath practice be designed and implemented to specifically cater to the unique needs of individuals with Parkinson's Disease and their care partners. * Objective 2: Will the SKY Breath practice decrease stress levels (a contributor to increasing PD symptoms) for individuals with Parkinson\'s Disease (iPD) and their care partners as measured through self-reported surveys to improve overall well-being and quality of life. * Objective 3: Will the SKY Breath practice in part alleviate the emotional stress and physical burden experienced by care partners of PD patients, promoting their resilience and well-being. Participants will be asked to learn the SKY Breath and Meditation practice over the course of 4 days (2.25 hours each morning), practice SKY every day for 4 weeks and keep a log of time spent doing SKY. The participants will complete a series of surveys before learning the practice and then after at weeks 1, 4 and 8. The series of surveys will take about 20 minutes.