Treatment Trials

30 Clinical Trials for Various Conditions

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ENROLLING_BY_INVITATION
The Fundamentals of Communication in Surgery
Description

The goal of this observational study is to evaluate the impact of the FCS curriculum on achieving the learning objectives and resident reported self-efficacy with communication skills and determine the scalability of the training across a range of general surgery training programs

RECRUITING
Pilot of an Online Sexual Health Program
Description

This study proposes to pilot an online intervention to support father-teen health-promoting talk about sex and relationships using Social Cognitive Theory, and to evaluate this intervention's acceptability, feasibility, and preliminary efficacy, using an Intervention Mapping approach. This study involves conducting a pilot intervention with 50 pairs of fathers and their high-school aged teens. Feasibility and acceptability will be assessed through program data such as participants' pilot enrollment, lesson feedback, and program retention, survey data and member checks through debrief interviews (5 father, 5 teens). Preliminary assessment of directionality of change in participants' health-related knowledge, self-efficacy, and outcome expectations over the course of the pilot intervention (pre- and post-intervention surveys) to determine whether a full-scale R01 is warranted.

UNKNOWN
A Tailored, Health Communication Intervention for HPV Vaccine Hesitant Families
Description

The human papillomavirus (HPV) causes 90% of cervical cancers and is implicated in multiple other cancers. The HPV vaccine can prevent the vast majority of these cancers, but it is underused in adolescents, especially among those within vaccine hesitant (VH) parents. The proposed research is to develop and pilot test a tailored, health communication intervention aimed to increase HPV vaccination among VH parents. The proposed research is innovative because no evidence-based health communication interventions target HPV VH parents, and we will use stakeholder engagement throughout this study. The research will add knowledge on how tailored education provided before a doctor's visit can play a role in improving HPV vaccination rates among underserved, VH parents.

RECRUITING
Keeping on Course: A Communication-Focused Psychoeducational Program
Description

The goal of Keeping on Course is to develop and test a psychoeducation program to provide dyads facing mild cognitive impairment (MCI) with communication skills and strategies that will establish or restore a sense of agency as they cope with MCI.

COMPLETED
Assessing the Impact of myHealth Rewards Program-related Communications on Enrollment: Replication
Description

The purpose of the study is to evaluate, prospectively, the potential impact on myHealth Rewards wellness program enrollment (prior to the 2020 deadline) of sending different messages via email to Geisinger Health Plan (GHP) members who have not yet enrolled. In particular, this study aims to replicate and extend (with greater sample size and statistical power) the findings from a previous study in which email communication using loss framing language achieved significantly higher click-through rates than a more standard communication, whereas actual enrollment rates were not significantly higher.

COMPLETED
Geriatric Communication Skills Training Program for Oncology Clinicians
Description

The purpose of this study is to learn more about the effects of a training program designed to help doctors communicate better with older patients and their caregivers.

COMPLETED
Enhancing Connections Program in Improving Communication Between Patients With Incurable Cancer and Their Children
Description

This pilot clinical trial studies the use of the Enhancing Connections Program in improving communication between patients with incurable cancer and their children. The Enhancing Connections Program is an educational program that may provide patients with new competencies to improve communication with their children and help them to cope with their parent's incurable cancer.

COMPLETED
Computer Program in Improving Communication Between Doctors and Patients With Stage IV Cancer
Description

RATIONALE: A computer program and education materials may help improve the ability of doctors to communicate with patients. PURPOSE: This randomized clinical trial is studying how well a computer program together with education materials works in improving communication between doctors and patients with stage IV cancer.

COMPLETED
Web-Based Tailored Educational Program in Improving Nurse Communication With Patients About Clinical Trials
Description

This pilot, randomized clinical trial studies a web-based tailored educational program in improving nurse communication with patients about clinical trial treatment options. A web-based tailored educational program may empower and prepare nurses to discuss clinical trial treatment options with patients and may also increase patient participation in clinical trials.

COMPLETED
Feasibility of a Clinician Training Program to Improve Patient-provider Communication in the Presence of Health IT Systems in the Exam Room
Description

The investigators propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. The investigators will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of best practices for clinicians interacting with patients in the presence of computer systems in the exam room. They will then establish the feasibility and potential impact of EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the intervention on the following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the physician's performance, asthma control, and asthma-related quality of life. Outcomes will be assessed on patients, but physicians will receive the intervention. Patients will not know which arm their doctor was randomized to. The pilot trial will compare two groups of primary care physicians who see patients with asthma in clinics equipped with certified EHRs. It is hypothesized that patients of physicians who receive EHR-PACE training will achieve better outcomes compared to physicians who do not receive EHR-PACE.

Conditions
COMPLETED
Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships
Description

The goal of this study is to learn if Media Aware Parent - Tween, an online program for parents of children ages 9-12, helps parents have effective conversations with their child about health and media.

RECRUITING
Reducing Obesity Using Social Ties Program
Description

This trial aims to test the feasibility and acceptability of addressing interpersonal barriers to weight-related behavior change. Specifically, the study will test if, by including up to two friends, family members, or co-workers in a lifestyle intervention for weight loss, the person enrolled in the study loses more weight than someone whose friends, family members, or co-workers were not invited to participate.

Conditions
ENROLLING_BY_INVITATION
Family Bridge Program
Description

Pediatric healthcare inequities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and demands imposed by the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address inequities related to communication and system navigation in the inpatient setting; given the established links between these inequities and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a diverse population of children and their families, The Family Bridge Program (FBP). The FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children of color, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest. In pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children of color. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits for families of low-income children of color; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children of color, including those who prefer a language other than English for their medical care.

ACTIVE_NOT_RECRUITING
Psychosexual Educational Partners Program (PEPP)
Description

The purpose of this study is to compare two Psychosexual Educational programs for women who have completed treatment for breast or gynecological cancer and their partners in preparation for a well-powered phase III study. The investigators plan to enroll 30 dyads in a 2-arm pilot randomized controlled trial (RCT). The primary aim will be to assess the preliminary efficacy of the Psychosexual Educational Partners Program (PEPP) on sexual communication.

COMPLETED
Feasibility Study of a Web-based Program to Help Parents of Middle School Students Effectively Communicate With Their Children About Substance Use
Description

The goal of this study is to test the feasibility of a web-based program for parents of middle school aged students. 286 parents and their child in 6th, 7th, or 8th grade will be asked to each complete two online questionnaires over the course of about a month, parents will also complete a web-based program between questionnaires. Researchers will compare the intervention and an active control to test the intervention program efficacy for improving outcomes related to parent-child communication, media message processing, and adolescent health.

COMPLETED
Optimizing Medication Management by Older Adults Through the Med Wise Rx Community-based Program
Description

This study's overall goal is to enhance older adults' communication skills to access medication information and services to manage their medications safely and effectively. Med Wise Rx is an online 2-session program to improve communication skills for accessing medication information and services, leading to improved medication management. 160 adults age 65 years or older taking 4 or more medications will be on study for up to 9 months.

RECRUITING
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Description

Background: For adolescent and young adults (AYAs) with certain life-threatening illnesses, hematopoietic stem cell transplant (HSCT) provides the best chance for cure and survival. HSCT is a life-saving therapy, but this treatment also comes with significant risks. Given these risks, it is imperative that patients and their families have the opportunity to share their values, priorities, and goals through advance care planning (ACP) to ensure that the care they receive through the transplant process remains patient-centered. Despite the benefits of ACP discussions, many barriers, including provider discomfort, may prevent these conversations with AYAs. Objective: To see if AYAs who undergo HSCT and their caregivers benefit from discussing ACP topics. Eligibility: People aged 18 to 39 years enrolled in an NIH study with a planned HSCT. One caregiver aged 18 years or older will also be invited to participate. Design: Participants will complete a 20-minute questionnaire. They will be asked about the priorities they have related to their care and their prior experiences with ACP. Participants will have 3 conversations with a study team member over 4 to 9 weeks. Each talk will last 45 to 60 minutes. First, participants will talk about their upcoming transplant and their expectations. They will also be asked about their fears and worries and will discuss what is most important to them in terms of support, comfort, their values, and their goals. Next, they will learn about Voicing My CHOiCES . This guide gives people a place to say what kind of care they want to receive during their treatment and includes a place to document how they would want to be cared for if they can no longer make decisions on their own. Participants will be guided as they fill in a few pages from this guide. The third conversation will review the first talks. Participants may ask questions and review any topic. They will complete follow-up questionnaires and be provided with a summary of their care priorities revealed in the discussions. They will be asked about their experience participating in this study, and their comfort with ACP discussions. They will be asked what they think of the meaningfulness, timing, and cultural sensitivity of these talks....

RECRUITING
USCRI READY4Life Program
Description

The U.S. Committee for Refugees and Immigrants (USCRI) has developed the Relationships, Education, Advancement, and Development for Youth for Life (READY4Life) Program. This is a 16-hour program for immigrants/refugees, ages 14 to 24. The program is designed to help young immigrants and refugees prepare for a successful life in the United States. The program is taught by USCRI program staff and is being implemented at eight sites across the U.S.: Cleveland, Ohio; Colchester, Vermont; Des Moines, Iowa; Miami, Florida; Philadelphia, Pennsylvania; Raleigh, North Carolina; Saint Paul, Minnesota; and Twin Falls, Idaho. The project also includes a rigorous evaluation component, featuring a Randomized Control Trial (RCT) design.

COMPLETED
High School SUCCESS: Vocational Soft Skills Program for Transition-Age ASD Youth
Description

By utilizing community-based participatory research methods, this research was conducted in collaboration with the community through our partnership of researchers, educators, providers and consumers (Active Collaborative Hub for Individuals with ASD to Enhance Vocation and Education- ACHIEVE) to adapt a vocational soft skills program, Supported, Comprehensive Cognitive Enhancement \& Social Skills (SUCCESS), for Transition Age Youth (TAY). The first step (years 1-2) involved adapting the intervention for autistic TAY by including feedback from multiple stakeholders and developing a curriculum to be implemented in both High Schools and Transition programs for the specific needs of autistic TAY and alpha piloting it. It involved understanding further the educational context for TAY students and current services available to prepare students for secondary outcomes of employment and/or college through a county wide survey. Step 2 (years 2-3) included pilot testing the feasibility, acceptability, implementation procedures and initial youth outcomes of the TAY SUCCESS intervention and further refining the curriculum and protocols. Findings demonstrated improvements in executive functioning and social functioning targets as well as distal outcomes of self-efficacy, mental health, educational and work behaviors and attitudes. The study results were disseminated through the ACHIEVE group as well as at conferences, website and publication.

TERMINATED
A Study to Implement and Evaluate REFLECT Communication Curriculum for Oncology Based Medical Graduate Students
Description

The purpose of this study is to collect data from quarterly workshops (standardized patient simulations, reflective narratives, questionnaires, surveys, standardized patient and peer feedback, and participant critiques) of participants enrolled in oncology-based residencies and fellowships will be collected. The information that is gathered from this study will be used to describe this population that participate in the workshop and see whether or not introduction of a communication curriculum alongside with the training program will improve communication, self-awareness, and interpersonal skills over time.

ACTIVE_NOT_RECRUITING
Efficacy of Family Programs for Improving Child and Family Health and Development
Description

The proposed research is relevant to public health because of the critical importance of infant attachment and early experiences to the lifetime trajectory of mental health and socio-emotional functioning. This Randomized Clinical Trial addresses major gaps in available family-wide programs that can promote healthy development that best serve infants, mothers, fathers, and inter-parental relationships in cost-effective ways. This study also systematically tests for which families the interventions are most effective and rigorously tests the theoretical processes that link changes in mother-infant, father-infant, and mother-father interactions with infant and parent outcomes.

COMPLETED
A Parent Child Program to Prevent Adolescent Pregnancy
Description

While the U.S. teen birth rate is currently at its lowest level, it remains high in relation to other industrialized countries and continues to be a public health concern due to health risks for teen mothers and their babies, and associated social and economic costs. Parental monitoring, supervision, and open communication about sexual issues have been found to be protective factors for adolescent sexual activity and pregnancy. Our theoretically based Internet program for parents of pre-adolescent children aged 10-14, Let's Talk about Sex, is designed to build parental communication, knowledge, and attitudes to discuss sensitive topics with their child, including sexuality, pregnancy prevention, and preventing sexually transmitted illnesses (STIs). This age group of children was selected because parental communication about pregnancy and STI prevention will be most effective if initiated prior to, rather than after, the age when children commonly become sexually active. The "Let's Talk about Sex" program is grounded in behavior change theory and incorporates the use of video for behavioral modeling and emotional support.

UNKNOWN
A Social Media Approach to Improve Genetic Risk Communication Phase I
Description

The goal of this research study is to create an internet-based program designed to improve the communication of health and health history information among family members affected by Lynch syndrome.

COMPLETED
Implementing a Comprehensive Handoff Program to Improve Patient Safety
Description

The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for internal medicine residents on inpatient units at Walter Reed and Madigan Army Medical Centers - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.

Conditions
COMPLETED
Initial Test of the Time to Talk CARDIO (Creating a Real Dialogue In the Office) Program
Description

This research focuses on communication practices between patients and health care professionals, like nurses, doctors, or physician assistants. The goal is to help improve communication about heart health issues. This pilot (or Beta) study is designed to test our ability to recruit an appropriate sample of participants, and determine our ability to deliver and evaluate the effects of a web-based intervention. The investigators hypothesize that exposure to the intervention will result in measurable changes in self-reported knowledge, attitudes and behavior regarding communication between patients and health care professionals. Participants in this research study are being recruited from the people who currently receive care at the Richmond Family Health Center of the Oregon Health \& Science University. People who participate in this study will be between 55 and 70 years old, speak English as their preferred language, and have one of several possible diagnoses related to heart health. These could include, for example, hypertension, diabetes, asthma, or obesity. Additionally, the investigators are recruiting a small number of health care professionals from the Richmond Family Health Center. Their participation will be similar to but separate from the participation of patients. All participants will take two web-based surveys. Some participants will use a web-based tool that hopes to help improve communication between health care professionals and patients. The surveys contain questions that explore the knowledge, attitudes, and behaviors of participants related to heart health and communication between health care professionals and patients. Data analysis will focus upon identifying any changes that occurred in knowledge, attitudes, or behaviors with respect to health communication after using the web-based tool, as well as learning about what influences the quality and nature of communication between health care professionals and the patients they serve.

COMPLETED
Evaluating the Collaborative Management in Pediatrics (CMP) Training Program Among Pediatric Resident Doctors and Their Patients With Asthma or Obesity
Description

Self-care behaviors are decisions and actions that people can take to improve their health or cope with a health problem. It is important for people with long-term illnesses to develop and maintain effective self-care behaviors. This study will evaluate the usefulness and practicality of the Collaborative Management in Pediatrics (CMP) program, which is a training program developed to encourage pediatric resident doctors to promote self-management of illness and behavior change among children with asthma or obesity and their families.

COMPLETED
Effects of a Worksite Parenting Program
Description

Many adolescents in the U.S., even very young adolescents, are engaging in sexual risk behaviors that put them at risk for sexually transmitted diseases (STDs) and unintended pregnancy. Studies show that parents can play a significant role in promoting healthy sexual development and risk reduction among adolescents. The UCLA/RAND Center for Adolescent Health Promotion has developed Talking Parents, Healthy Teens, a worksite-based parenting program for parents of adolescents (grades 6-10) to improve parent-adolescent communication and reduce adolescent sexual risk behaviors. We are evaluating the effectiveness of the program primarily with confidential surveys of the participants before and after the program.

COMPLETED
Linking Lives: Building Quality Parent Components for School-Based Health Programs in Middle Schools
Description

The purpose of this study is to develop and evaluate the effectiveness of a parent-based intervention that can be implemented in conjunction with existing school-based programs designed to prevent or reduce sexual risk behavior or to prevent or reduce tobacco use in young adolescents. The parent programs are expected to have effects on adolescent behavior over and above the effects of the school-based programs.

COMPLETED
An Evaluation of the Team Birth Project
Description

The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States

COMPLETED
Effectiveness of an Online Parenting Training
Description

Child and adolescent behavioral health problems are related to the leading causes of youth morbidity and mortality. Parent-focused preventive interventions, such as GenerationPMTO (GenPMTO), effectively prevent behavioral health problems such as depression and conduct disorders. Unfortunately, parenting programs are not widely available nor well-attended. Pediatric primary care (PC) is a non-stigmatizing setting with nearly universal reach and, therefore, an ideal access point to increase availability. However, PC personnel are not trained to address behavioral health topics. Also, typical referral practices are inadequate. There is a need to develop effective referral practices in conjunction with increasing availability. There are also logistical barriers to attending in-person parenting programs, like the need for childcare and a large time-commitment. There is a need to overcome these logistical barriers with more accessible programs. The long-term goal is to prevent significant behavioral health problems by increasing access to GenPMTO.