52 Clinical Trials for Various Conditions
This clinical trial evaluates a community health education intervention (I CAN) for increasing community-driven actions to reduce the cancer burden in Western New York. Engaging community members is a critical component of designing impactful programs to reduce the cancer burden. Leaders at the national, state, and local levels have all called for more community partnerships and engagement in design of health intervention and policies. The I CAN intervention is a workshop that includes a presentation outlining key concepts related to social network processes and the cancer burden in Western New York, a structured skill-building activity, and then empowering and motivating activities meant to cultivate momentum and excitement for action. This community health education intervention may be able to provide a formalized process for empowering and facilitating community members to take steps to reduce the community cancer burden.
This study evaluates the feasibility and the potential positive health impacts of a novel "health education theater," which will task participants of a health education program to create an original 10-minute theater that is required to use the health guidelines about physical activity and diet/nutrition. The outcomes include the changes in (a) knowledge about these guidelines, (b) compliance to these guidelines, (c) health related quality of life, and (d) self-perception well-being measures such as self-esteem and self-efficacy.
Obesity is significantly higher in specific ethnic groups and, in particular, Hispanics. There is an urgent need to implement culturally-sensitive lifestyle interventions and educational programs to decrease the burden of obesity and obesity-related metabolic diseases in Hispanic populations. Accordingly, our overreaching goal is to tailor an existing and successful community-based program, Abriendo Caminos, to leverage effectiveness in promoting healthy nutrition and life-style behaviors among low income, low literacy Hispanic-heritage families. Our multi-function integrated project proposes to (a) adapt Abriendo Caminos for 6-18 year-old children from Mexican and Puerto Rican heritage in five different locations (California, Illinois, Iowa, Puerto Rico, and Texas) and (b) Train existing professionals (in Extension and community agencies) and future professionals (Hispanic university students) to meet the specific needs of this population. Our central hypothesis is that participation in a 6-week community-based program will prevent childhood obesity/maintain healthy weight by significantly increasing: (a) healthy dietary behavior patterns and basic knowledge of nutrition; (b) physical activity levels; and (c) the organization of collective/shared family mealtimes. The implementation of this culturally sensitive, workshop-based curriculum in different regions across the country will help to train the next generation of professionals in Extension and communities to deliver programs that meet the needs of Hispanic families. The integration of Hispanic college students in program implementation via an experiential learning course will further strengthen the program, as well as increase recruitment and retention of Hispanic students, increasing the capacity of Hispanic communities to meet their own needs in the future.
What is United4Stroke (U4S)? United4Stroke is a research program at the University of Texas at El Paso (UTEP) that aims to help stroke survivors become more active and reduce sedentary time through education, movement, and personalized coaching. Where Does It Happen? All sessions take place at: UTEP's Rehabilitation Sciences Complex located at 3333 North Mesa Street, El Paso, TX 79902 What is Involved? The program includes 12 total visits over several months: * 8 group sessions (held every two weeks) * 4 individual evaluation visits (before, during, and after the program) Who Can Participate? * Individuals 18 years of age or older who have had a stroke at least 6 months prior to joining the study. * Family caregivers may also join What Happens During the Visits? First Visit: * Learn about the study and give consent * Answer questions about memory, movement, general health, and daily activity * Do walking and mobility tests * Get fitted with a small movement sensor (ActivPAL) and a Fitbit Group Sessions (Visits 2-8): * Topics: physical activity, sitting less, balance and falls, and activities of daily living * Led by UTEP physical therapy faculty * Includes group discussions and hands-on activities * Some participants will also get one-on-one coaching to help with physical activity engagement, daily step count, and reducing sedentary behavior. Follow-Up Visits (Visits 9 and 11): * Repeat earlier tests to check progress * Share feedback about the program Final Visit (Visit 10): * Celebrate progress! * Social gathering, certificates, and a presentation of results Goal: To support stroke survivors in becoming more active and living healthier, more independent lives-step by step.
The overarching goal of the proposed intervention is to reduce stroke disparities by overcoming pre-hospital barriers related to emergency stroke treatment and facilitating the appropriate response to acute stroke using a novel culturally-tailored and sustainable approach developed by an experienced transdisciplinary team. Building on our previous work, in which the investigators have identified barriers to increasing stroke literacy and behavioral intent to call 911, the investigators will develop and evaluate the effectiveness of a novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-minute films (in English and Spanish), in minority populations in New York City (NYC). Behavioral intent to call 911 will be assessed immediately after viewing the film, 6 months later, and one year later.
The purpose of this project is to conduct a community-based intervention and evaluate the independent and combined effects of two intervention strategies on primary and secondary prevention of colorectal cancer (CRC) among members of rural Appalachian churches. The sampling frame consists of all of the churches in a 7 county area of western West Virginia. Eligible churches will have at least 180 active members, will not share a common pastor, and will have no CRC control activities. Using a 2x2 experimental design, churches will be divided into two separate clusters, those with and without an existing parish nurse program. Then churches from each cluster will be randomized to one of two conditions, a natural helper or a control condition.
This community based participatory research study involves multicomponent educational interventions. Telephone interviews and focus groups of persons who are residents of the High Plains region of Colorado will be conducted. A card study will also be carried out to collect limited data about colorectal cancer screening in primary care practices. The multicomponent intervention approaches (e.g., small media and group education) consist of educational materials about routine colorectal cancer screening.
During this first year, the researchers have worked toward identifying factors influencing initiation of colorectal cancer screening among Hispanic men and women aged 50 and older and developing an intervention plan using Intervention Mapping, a framework for systematic health promotion program planning, implementation, and evaluation. The researchers are also currently in the preliminary stages of developing two promotora (lay health worker)-delivered interventions: a small media intervention (video, flip chart, pamphlets) and a tailored interactive multimedia intervention, prior to the actual collection of data. Thus, although 733 subjects have been approved by the Committee for the Protection of Human Subjects to be enrolled in this study in the future, no subjects have been enrolled at this time. Consequently, there have been no adverse events, and since the risks associated with participating in this study are negligible, the researchers do not anticipate any adverse events in the future. No modifications have been made to the research since the last review, other than that the researchers are currently reassessing the need to conduct preliminary qualitative research as proposed in the original protocol.
Many patients have difficulty performing routine medication management tasks. Individuals with limited literacy are at high risk for these problems. The overall study objective is to rigorously evaluate two primary care-based medication therapy management strategies that leverage an electronic health record (EHR) to promote patient understanding, medication reconciliation, medication adherence and disease control among hypertensive patients at safety net clinics.
The study design is a randomized intervention evaluation. Ten senior centers in predominately African American communities in the Birmingham, Alabama will be selected as sites for the educational intervention. Five centers will be randomly assigned to receive an educational intervention communicating practical information about vision, eye conditions and eye care as pertinent to the older African American population. The other five centers will serve as social-contact controls, where participants will receive an engaging information session on a non-health related topic. The primary outcome of interest is the change in percentage of persons receiving comprehensive eye care from pre- to post- intervention. The secondary outcomes are the process outcomes of improvement in knowledge, attitudes, and values about vision, eye conditions, and eye care.
This study aims to develop educational tools and platforms to promote the transfer of sleep health information to blacks to foster adoption of healthful sleep practices.
This will be a study looking at trying to change community-dwelling older adults' behavior in regard to good sleep hygiene practices. Investigators will assess the efficacy through subjective outcome measures and objective physiological markers of good sleep through data collected with wearable technology devices.
It is essential to provide the community with evidenced-based care to optimize healthcare outcomes; more specifically, women in underserved communities undergoing health disparities in rehabilitation. To address this issue, a movement-based pelvic health education course was developed to assess women's knowledge and adherence of the exercises in an underserved region in Western Arkansas.The purpose of this research was to determine the effectiveness of a single movement-based pelvic health education session on general pelvic health knowledge, underactive pelvic floor, and overactive pelvic floor knowledge and adherence to performing pelvic exercises in women.
The study is of high importance to Veterans' health because it will study a suicide prevention intervention in a Veteran population that is at high risk of suicide but has not been a specific focus of the Veteran Affairs' (VA's) suicide prevention efforts. Specifically, a growing number of Veterans are now receiving acute mental health treatment in VA-purchased settings (commonly referred to as Community Care). While these Veterans are at high risk of suicide after discharge, very little is known about how to prevent suicide in these Veterans. This study will directly address this problem by looking at whether a promising suicide prevention strategy called the VA Brief Intervention and Contact Program (VA BIC) can decrease the risk of suicide in Veterans after they are discharged from a non-VA mental health treatment setting. The proposed research is highly pertinent to the VA's top clinical priority-to prevent suicide in Veterans.
The goal of this community-engaged research is two-fold. The first goal is to gather stakeholder feedback to inform a school-based community health worker intervention with youth with poor school attendance and an enhanced usual care condition. The second goal is to evaluate the feasibility of implementing the school-based community health worker intervention and enhanced usual care approach within rural schools. The main question it aims to answer is whether it is feasibile to recruit children with poor school attendance and their families to the intervention, to complete the trauma-informed intervention, and to complete the associated study measures of meeting social determinants of health/mental health needs, school-based health center utilization, and behavioral helath symptoms. At least 38 rural students in grades 6-12 with poor school attendance and their parents/guardians will meet with the school-based community health worker for support around social determinants of health needs that may be barriers to attendance. Researchers will also assess the feasibility of recruiting at least 10 rural students and their parents/guardians to complete the study measures in an enhanced usual care condition in which the school-based health center without a school-based community health worker is reminded of the availability of an online social services directory.
The goal of this pilot randomized controlled trial is to test an adapted suicide prevention program (the Building VA Engagement, Self-efficacy, and Social Support To Prevent Suicide or BESST) in rural Veterans discharged from community care mental health treatment settings. The main question it aims to answer is: * Does BESST combined with standard care improve suicide-related outcomes among this population compared to standard care alone? Participants will be assigned by change to a treatment group. Some will receive the BESST intervention combined with standard care, and some will receive standard care alone. All participants will be in this research study for up to three months. Those receiving the BESST intervention will have: * 1 one-hour brief educational session; * Seven follow-up check-ins (\~30 minutes each) All participants will have three assessment interviews where they will be asked about their mental health and treatment received outside of the VA. The investigators will compare participants assigned to the BESST intervention combined with standard care vs participants assigned to standard care alone to see if the BESST intervention improves suicide-related outcomes.
The goal of this proposed study is to pilot test a novel treatment model (PRE-CARE) addressing unmet social needs for families of preschool-age children with Attention Deficit/Hyperactivity Disorder (ADHD) symptoms. The investigators will conduct an adaptive, pilot randomized controlled trial (RCT) of the intervention with parents of 60 low-income children age 3-5 (36-71 months) with ADHD symptoms in order to: optimize intervention delivery; field test study logistics (e.g., recruitment, enrollment, randomization, retention); explore putative intervention mechanisms; and obtain estimates of study parameters to plan an appropriately powered RCT of the intervention. The PRE-CARE intervention is adapted from Well Child Care, Evaluation, Community, Resources, Advocacy, Referral, Education (WE CARE), a screening and referral intervention that has been shown to be feasible and effective in addressing the family psychosocial stressors of low-income families seen in pediatric medical homes. Given the negative impact that socioeconomic stressors can have on the health and development of young children with ADHD symptoms, tailored interventions such as PRE-CARE may serve as a vital early intervention strategy to promote long-term well-being.
Despite reductions in adolescent sexual behavior over the past decade, premature sexual activity remains prevalent among adolescents and alarming adolescent sexual and reproductive health (SRH) disparities exist. Positive youth development (PYD) research has identified adolescent protective factors, such as success sequencing, self-regulation, goal setting, and strong family support \[i.e., positive family development (PFD)\] that are associated with increased sexual risk avoidance as well as individual life opportunities and societal benefits. Needed are programmatic efforts to strengthen adolescent protective factors among populations in greatest need, with a particular emphasis on the important role of parents in promoting sexual delay. The proposed project is designed to target Latino and Black adolescents aged 12-17 years residing in the South Bronx, New York City, a high-need community for sexual risk programming and promotion of adolescent life opportunities. The investigators evaluate a program called Families Talking Together Plus (FTT+), an online, parent-based intervention that is medically accurate, culturally tailored, and age-appropriate. To implement FTT +, the investigators draw upon an innovative and culturally competent intervention delivery approach, namely community health workers (CHWs) as "Life Opportunity Coaches."
In this pilot randomized control trial, the investigators will evaluate the feasibility and acceptability of using a video and website in a prenatal visit to provide breastfeeding education, focusing on how to hand express (HE) breast milk. Participants will be randomized to the video/website intervention group or to the control standard of care group. After delivery, participants will be asked to provide information on how long they breastfed and if they used the information in the video and website. Differences in the outcome measures will be analyzed between the two groups.
The purpose of this protocol is to develop and evaluate an HIV prevention Entertainment Education (EE) intervention aimed at reaching underserved, at-risk African Americans, aged 18-25 years, living in disadvantaged urban neighborhoods in the Birmingham area.
The specific aims of this study are: Aim 1. Develop a staged and modifiable dyadic oral care intervention to provide functionally-tailored oral care rehabilitation for community-dwelling persons with dementia (PWD) and need-based skills training their family caregivers (CGs). Based on the literature review and MCWB, a 4-week intervention with 8 modules, including universal modules (e.g., environmental changes), CG modules (e.g., cuing strategies) and modules for both PWD and CGs (e.g., oral care techniques), will be developed addressing the relevant SCT constructs (e.g., functional deficits of PWD and caregiving needs of CGs). Guided by a validated, widely-used theory of rehabilitation medicine, modules will be used alone or in combination to provide personalized, hand-on, functionally-tailored oral care rehabilitation for PWD along with skills training for CGs to match their caregiving needs. The training focus shifts from the PWD to the CG, as the independence of the PWD decreases. Semi-structured interviews with family CGs will then be conducted (until data saturation is reached) to understand their oral care needs, desired intervention approaches, and the perceived feasibility and utility of the intervention. The intervention will be revised and then pilot tested with 4 dyads, one per each of the four functional levels of the DAT. Aim 2. Evaluate the feasibility and efficacy of the intervention in home settings through a randomized, controlled trial with 40 pairs of PWD and their primary CGs, including immediate post-intervention and 3-month follow-up. Dyads will be stratified into 4 functional levels based on the PWD's DAT score and then randomly assigned to the intervention or control (non-tailored usual care) group.
The objective of this study is to recruit influential community members using Snowball Sampling Methods. Community members identified through social network analysis as influential and well-connected will be trained as community health workers (CHW) using the Diabetes Empowerment Education Program (DEEP). These CHW will be used in a future trial to educate other members of the community.
This study tests an intervention designed to avoid 30-day readmissions following a medical hospitalization by patients who have co-occurring mental illness. The Intervention is delivered by community health workers in the inpatient setting and 30 days following hospital discharge to the community.
Currently in the United States, the achieved level of glycemic control for adult Latinos with type 2 diabetes (T2D) is sub-optimal compared to the non-Latino Caucasian population. Among Latinos with T2D, there are unique barriers, such as socioeconomic and cultural factors, to starting and optimizing therapies, including insulin. Latinos have cultural beliefs and behaviors specific to this population that should be appropriately addressed in a diabetes self-management education and support program. Diabetes Pueblo is a diabetes education program that may be a solution to help address the barriers Latinos with T2D have to diabetes care and insulin use. The Diabetes Pueblo program consists of two targeted diabetes education curriculums for the local Latino community: (a) Diabetes Fundamentals and (b) Insulin Success, a culturally appropriate program course addressing barriers to initiating and optimizing insulin and T2D therapies. We will explore if Diabetes Pueblo Program improves knowledge of lifestyle advice for healthy eating and physical activity, increase the propensity to use insulin when clinically indicated, and improve success rates with insulin therapy by addressing common fears and negative perceptions of T2D therapies in this population.
Studies have shown that ethnic-racial minority elders are more likely to be neglected from appropriate dementia care in time than the white counterparts. Among minorities group, Korean Americans (KAs) are the 4th largest and one of the most rapidly growing Asian subpopulations and have been characterized as under-resourced and underserved population of dementia care. This research is being done to understand how an education and navigation support program led by trained community health workers (CHWs) helps Korean American elders with probable dementia and the Korean American elders' caregivers. In a 2-arm randomized controlled trial (RCT) with 288 dyads, the investigators' aims are to (1) test the effect of a community-based intervention delivered by trained CHWs for undiagnosed KA elders with probable dementia and the KA elders' caregivers, (2) evaluate the effect of the PLAN on improving caregiver's dementia literacy, self-efficacy in dementia care and service use, social support, depression, and quality of life at 6 months in comparison to usual care, and (3) examine whether the effect of PLAN differs across age, sex, English proficiency and education caregiver subgroups. Exploratory Aim 1 is to test the effect of PLAN on Korean elders with probable dementia and caregiver development of a plan regarding dementia care at 6 months in comparison to usual care. The other two Exploratory Aims are to test the applicability of this study in another environment: Exploratory Aim 2: Using an equity-informed human-centered design framework, scale PLAN for implementation in ethnic daycare and Exploratory Aim 3: Pilot test the feasibility and acceptability of PLAN in ethnic adult daycare. Aim 1 and Exploratory Aim test the following hypotheses: (1) Korean elders with probable dementia who receive the PLAN will have higher rates of linkage to medical service for dementia than those in the control group (Aim 1) and (2) Korean elders with probable dementia and the KA elders' caregivers who receive the PLAN will have higher rates of having a plan for dementia care than those in the control group (Exploratory Aim). Aim 2 tests the following hypothesis: Caregivers in the PLAN group will have higher dementia literacy, self-efficacy in dementia care and service use, social support, and quality of life, and lower depression than those in the control group.
The primary goal of this PCORI proposal is to evaluate the impact of enhanced provider and clinical staff training to address the health disparities of SGM CHC patients to ultimately improve their health outcomes because CHCs are a key part of the U.S. health care delivery system for underserved populations. The current application proposes to test an intervention designed to understand how CHCs, including front line staff and safety net clinical providers, can identify and provide optimal care for their SGM patients, and will determine whether enhanced training of CHC staff in best practices for the provision of primary care for SGM patients will improve their clinical outcomes. The time is right for routinization of SOGI measures in EHRs and evaluation of the optimal methods to train primary care providers in the best practices for the care of SGM patients.
This research study is aimed at the prevention of excessive weight gain in female military dependents at high risk for adult obesity. The purpose of this study is to determine whether reducing Loss of Control (LOC) eating and associated indicators through use of interpersonal psychotherapy (IPT) will be feasible and acceptable to female adolescent dependents who report such behaviors. Moreover, patterns in the data will be examined to assess whether IPT influences body weight gain trajectories and prevent worsening disordered eating and metabolic functioning among female military dependents at heightened risk for unhealthy weight gain.
Dental caries (tooth decay) is a disease with significant public health implications afflicting low-income children, with marked rural disparities in disease prevalence and treatment. More than 70% of 11th grade children in Crook, Deschutes and Jefferson counties have experienced tooth decay. Effective approaches to prevent decay include brushing with fluoridated toothpaste and professional dental care. Medicaid enrolled children are legally entitled to dental care under Early Periodic Screening, Diagnosis and Treatment (EPSDT), yet \<50% had any care in 2010. Free distribution of toothpaste and toothbrushes combined with parental education can increase toothbrushing frequency and reducing tooth decay. However, many parents are confused about when to start, how much and often toothpaste should be used, and how to overcome behavioral difficulties in brushing toddlers' teeth or getting older children to brush their own. The investigators' objective is to implement and evaluate a community-wide toothpaste distribution campaign enhanced by telephone support for OHP children and adolescents and their families in Central Oregon
A randomized controlled trial for chronic low back pain in predominantly minority populations with three treatment arms: yoga, physical therapy, and education. Four cohorts of participants will be randomized in a 2:2:1 ratio (yoga:physical therapy:education). Primary outcomes are pain intensity and measure of disability; secondary outcomes are pain medication use, treatment adherence, and health-related quality of life.
America's greatest resource is its youth, but that resource is increasingly threatened by violence. Recommendations for violence prevention have highlighted the need to focus on youth and to explore targeted interventions Nowhere is the need greater than in our nation's capital where the intentional injury fatality rate for youth age 14-19 is higher than any of the 50 states. This study builds on the CDC-supported project Adolescent Violence: A Community-Based Strategy which instituted citywide surveillance on injuries, conducted by researchers at the Children's National Medical Center. In this study, the same researchers will extend that work by testing an individualized intervention to reduce violent behavior among a sample of assault-injured youth, age 9-15, who present at the Emergency department (ED). 196 youths and their families will be included in this randomized trial, with 98 families assigned to the individualized intervention condition and 98 families assigned to the control condition. Families will be followed for 18 months. To address issues of attrition over the 18 months that the study follows, approximately twice as many families, or 400 families, will be recruited to participate in the study.