28 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if a new preoperative handout for patients undergoing robotic sacrocolpopexy will improve patient sense of preparedness and satisfaction in comparison to the previously used handout. The main questions it aims to answer are: * Does the new preoperative handout for patients undergoing robotic sacrocolpopexy improve patient preparedness and satisfaction? * Will the new preoperative handout for patients undergoing robotic sacrocolpopexy impact postoperative queries in the form of phone calls and messages to the clinic? Participants will: * Receive routine counseling regarding robotic sacrocolpopexy from their surgeon * Be randomized to the new or old preoperative handout * Undergo robotic sacrocolpopexy * Complete a questionnaire at their 4 week postoperative follow up visit regarding their sense of preparedness for surgery and overall satisfaction
A two-arm parallel randomized controlled trial will be conducted to compare the effectiveness of a phone-based household emergency preparedness intervention with a mailed informational brochure on household emergency preparedness amongst a sample of World Trade Center Health Registry enrollees residing within New York City.
There are 3 aims of this study. In Aim 1 community patient partners will be enrolled to help guide the research being performed in all of the aims. Investigators will also administer a survey that will help determine factors associated with surgical preparedness. In Aim 2 investigators will develop an intervention to increase surgical preparedness using Human Centered Design Methods. Aim 3 will pilot test the intervention using mixed methods to determine feasibility and implementation outcomes.
The purpose of this study is to determine if a fall preparedness program can reduce the fear of falling in older adults and subsequently improve their function and reduce falls with injury. Participants will perform baseline measures 4 weeks before intervention and again at the start of intervention. They will perform a 12-week intervention and then complete outcome measures again at the conclusion of the program.
Food pantries face many challenges, including recruitment and training of staff/volunteers, communications with staff/volunteers and clients, providing client choice, and emergency preparedness. The investigators will develop, implement, and evaluate the Support Application for Food Pantries (SAFPAS), a mobile application to address these concerns under normal and emergency operations, and assess its impact on 20 Baltimore food pantries, and on the healthiness of foods received by 360 food pantry clients using a randomized controlled trial design. If successful, the tested and refined app will support local food assistance programs throughout the United States.
School leaders, staff, and teachers are tasked with keeping children safe from acts of violence, natural hazards and other emergencies while encouraging learning. Disaster plans are often developed without teacher involvement, resulting in limited knowledge of emergency preparedness, undermining buy-in and limited motivation to comply with safety protocols, including disaster drills. The lack of initial consultation and limited decision-making authority can also be sources of stress for teachers. Teachers and staff may experience anxiety about their roles and responsibilities in a crisis. This research project proposes that the key to enhancing emergency preparedness in this population is to incorporate 'psychological preparedness' within a disaster management framework. In other words, to provide the school workforce with awareness of their likely psychological response to threat and coping skills/strategies for management of that response. Importantly, workforce-focused mental health integrated approaches to emergency preparedness are likely to work best if implemented via peer support and shared leadership frameworks. This project involves adaptation and implementation of an integrated workforce mental health intervention into Pre-K-12 school emergency preparedness via shared leadership and peer support. This includes co-creating training curriculum with Pre-K-12 schools, labor organizations, and district officials, implementing and evaluating the impact of the intervention. A matched waitlist control comparison research design will be used with six Pre-K-12 schools. The hypothesized outcomes of the intervention are increases in H1: emergency preparedness climate; emergency preparedness specific H2: shared leadership; H3: peer support and social cohesion; H4: confidence (in emergency preparedness); and H5: psychological preparedness. The project also anticipates H6: increases in overall mental health and well-being, and H7: a reduction in emergency preparedness-specific burnout.
Individuals with dementia and their families are especially vulnerable during a disaster as it limits caregivers' ability to continue with care due to disaster related stress and reduced access to resources and support. The COVID-19 pandemic showed the extreme vulnerability of persons with dementia (PWD) and their caregivers as they struggled to access support and resources due to the threat of COVID-19 infection; such impact was exacerbated in rural areas where caregivers are geographically isolated and disaster management resources are scarce. With the number of federally declared disasters increasing dramatically over the past 50 years, active public health efforts are needed to support caregivers in developing emergency caregiving plans usable in disasters such as pandemics and extreme weather emergencies. The long-term goal of this project is to enhance emergency preparedness and support networks of caregivers of PWD to increase their resilience and minimize distress by implementing an intervention program, Disaster PrepWise (DPW). In the DPW program, a trained Medical Reserve Corp (MRC) volunteer will provide step-by-step guidance to caregivers to jointly develop emergency preparedness plans and personal support networks. The objectives of this proposed study are to 1) test the impact of DPW on caregiver outcomes (i.e., resilience, stress) and perceptions that may mediate the association between DPW and outcomes (caregiver self-efficacy, preparedness, social support); and 2) evaluate implementation strategies in a real-world setting to optimize future dissemination. We will conduct a randomized control trial of 250 caregivers of persons with dementia involving two arms: DPW intervention group and an information-only control group (print information on disaster preparedness). Assessments will occur before randomization (baseline), and 3 and 6 months after the baseline. This study is innovative in its use of a highly personalized disaster preparedness program with built-in assistance to support caregivers; the support will be provided through an existing national-level public health infrastructure (MRC) that has a great potential to reach older adults and caregivers in rural areas. The knowledge and data obtained through this study will lay the foundation for a future larger-scale multi-state pragmatic trial to assess dissemination potentials.
Magnetic resonance imaging is an important and increasingly prevalent imaging modality used in healthcare. Children often find the procedure anxiety provoking causing difficulty in staying still and providing quality images. The use of preparation techniques including play therapy and role play utilizing such tools as a fiberglass mock MRI have shown to reduce anxiety and facilitate better image quality. Modalities of preparation including Virtual Reality (VR) pose as an alternative to habituate children for a MRI procedure.
Severe Acute Respiratory Infection (SARI) is defined by the World Health Organization (WHO) as acute respiratory infection with a history of fever ≥38°C and cough for less than 10 days duration that requires hospital admission. SARI-PREP is a multi-center consortium funded by the CDC Foundation being assembled with the goal of providing the infrastructure to rapidly collect prospective data on clinical risks and outcomes, hospital-level stress, and biologic specimens that will aid in the rapid development of diagnostic and treatment approaches. A current example of a form of SARI to be targeted by SARI-PREP is COVID-19 the acute respiratory infectious disease caused by SARS-CoV-2 infection. COVID-19 has a broad set of manifestations and severity with a subset of affected patients developing severe disease leading to respiratory failure and other forms of organ dysfunction. As with many outbreaks of novel viral pathogens causing SARI there was no efficacious therapeutic intervention at the beginning of the COVID-19 pandemic. Furthermore, while there is emerging knowledge of clinical risks for severe COVID-19, there remains a paucity of information about the viral dynamics and host responses that might indicate a patient is at high risk for poor outcomes. The COVID-19 pandemic will be the initial target of the SARI-PREP consortium with the overall goal of developing a multi-institutional collaborative network of Acute Care Hospitals that will rapidly enroll, sample, and follow patients admitted with severe COVID-19 and to develop research protocols to rapidly determine demographic, clinical, host molecular, virologic, and institutional correlates of outcome. Overall, the information gained from this effort will help to rapidly inform and improve clinical management of epidemic/pandemic SARI patients.
To develop an audiovisual decision aid (AVDA) to improve the informed consent process. The investigators aim to examine the impact of a comprehensible AVDA that is written below the 8th grade reading level. The AVDA would be used for surgical consent compared to traditional verbal consent. Additionally, the investigators plan to determine whether this effect varies across the measured levels of health literacy of our patients.
Surgical preparedness improves patient satisfaction and perioperative outcomes. In urogynecology, interventions to increase preoperative patient preparedness have not been adequately studied. Our objective is to evaluate the ability of preoperative provider-initiated telephone calls to increase patient preparedness for surgery. The investigators will conduct a randomized control trial comparing surgical preparedness between provider-initiated telephone call three days before surgery plus usual preoperative counseling versus usual preoperative counseling alone among women planning to undergo pelvic reconstructive surgery as measured by the Preoperative Patient Questionnaire (PPQ) and the Modified Preparedness for Colorectal Cancer Surgery Questionnaire (Modified PCSQ). Surgical satisfaction, perioperative outcomes, and medical costs will be also be compared between the two groups. Our hypothesis is that preoperative telephone calls will result in improved surgical preparedness. This novel approach in preoperative counseling has the potential to positively impact perioperative patient care. The investigators will also conduct an ancillary qualitative study of sexually active women undergoing pelvic reconstructive surgery who are enrolled in the randomized control trial. This work will aim to describe the patient experience, concerns, and the quality of the first sexual encounter following surgery. This ancillary study will lay the foundation for future investigations into how to better counsel patients and discuss sexual activity after surgical repair.
Patient preparedness has been associated with increased patient satisfaction, decreased postoperative pain and decreased postoperative narcotic use; however, little is known regarding the optimal way to prepare patients prior to pelvic reconstructive surgery. The primary aim of this study is to determine if a preoperative counseling in person visit has similar rates of patient preparedness as a preoperative counseling phone call for women undergoing same-day pelvic organ prolapse surgery. Secondary aims evaluate patient satisfaction, postoperative pain scores and postoperative narcotic usage. Women who plan to undergo pelvic organ prolapse surgery will be randomized to a preoperative in person counseling visit or a preoperative counseling phone call. Participants will complete questionnaires to assess their preparedness, satisfaction and postoperative pain. The goal of this study is to gather information that will allow clinicians to improve patient surgical preparedness and satisfaction.
This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness.
Heart failure is a chronic and frequently terminal illness associated with poor quality of life and high burden of morbidity, re-hospitalization, and cost. Accordingly, recent guideline updates have highlighted the need for improved focus on end-of-life and palliative care of advanced heart failure patients, in whom symptom burden can be high and treatment options are often limited. The aims of this study are to evaluate the feasibility of implementing a semi-structured, outpatient, nurse practitioner-led, educational supportive care intervention concerning multiple domains of end-of-life care not often included in regular, outpatient clinic visits.
This is a single-blind, randomized (1:1 allocation), stratified, single-parallel clinical trial at one institution evaluating the use of a preoperative patient education video as an adjunct to preoperative counseling on patient-centered outcomes. The aim of this study is to determine the impact of a preoperative patient educational video as an adjunct to the routine preoperative visit on patients' preparedness for surgery, perception of time spent with their healthcare team, and ultimately their satisfaction after surgery. The aim of this video is not to limit the doctor patient interaction (as all patients will still be granted their pre-allotted 30 minute visit with the physician regardless of their intervention allocation) but rather to augment the visit with additional educational information in an attempt to optimize the visit. Objective: A. Primary Aim(s): • To determine if patients feel more prepared for surgery with addition of preoperative patient education video B. Secondary Aim(s): * To determine if addition of preoperative patient education video correlates with improved patient satisfaction after surgery * To determine if patients' perception of time spent with healthcare team in preparation for surgery increases with addition of patient educational video * To determine if actual patient-physician time spent counseling differs between groups * To determine if patient preparedness is correlated with objective surgical outcomes * To determine if patient preparedness is correlated with patient symptom improvement scores after surgery Hypothesis: The addition of a preoperative patient education video enhances patient preparedness for surgery, increases perception of the amount of time patients spend with healthcare team, and improves patient satisfaction.
Moffitt Cancer Center is the Coordinating Center for this study. The purpose of this study is to develop and test the infrastructure to conduct a future Phase III vaccine efficacy trial to assess trial feasibility, and to assess human papillomavirus (HPV) genotype distribution, data needed to design a Phase III trial. The investigators propose to conduct a Preparedness study among women ages 16-24 years of age residing in a region of South Africa with a high human immunodeficiency (HIV) incidence and prevalence. The specific aims of this study are to: 1. Identify, recruit, enroll, and randomize a cohort of HIV negative women (200 per arm, 400 total) ages 16-24 years to an HPV vaccine against 4 types (HPV 6, 11, 16, 18 \[Gardasil\]) or placebo vaccine. 2. Determine the cervical HPV prevalence and type distribution at enrollment, and cervical lesion prevalence among young females ages 16-24 years at high risk for HIV infection. 3. Assess the rate of compliance through the 3-dose vaccination series
The primary aim of the survey is to ascertain the emergency preparedness among our families with diabetes mellitus and to obtain a percentage of unprepared to the ones who are prepared. The secondary aim is to demonstrate the relationship between disaster preparedness and factors like socio-economic status, parent's marital status, ethnicity and those who had prior experience of a disaster to those who have not experienced a disaster.
Despite risk reduction counseling, some individuals in HIV vaccine trials or vaccine preparedness studies may engage in risk behavior that results in HIV infection. The purpose of the HVTN 403 study is to find out more about how persons respond to HIV infection if they have received an experimental HIV-1 vaccine before they became HIV infected. Some people in HVTN 403 received an experimental HIV vaccine as a participant in a clinical trial before getting infected with HIV. Other people in this study were in a vaccine preparedness study when they got infected with HIV. None of these individuals became infected with HIV as result of their participation in an HIV vaccine or vaccine preparedness study. HVTN 403 will compare immune responses between those who previously received an experimental HIV vaccine and those who did not. Information learned from this study may be important in guiding future developments of new HIV vaccines and other treatments for HIV and AIDS.
The purpose of this study is to estimate the rate at which a certain population becomes infected with HIV. The individuals examined in this study are people who are expected to take part in future studies of HIV vaccines and nonvaccine HIV prevention studies. This study also examines the chances of becoming HIV-positive based on certain risk factors under conditions that are similar to the conditions that would exist in HIV vaccine and non-HIV prevention studies. Before studying the effectiveness of a potential HIV vaccine, it is important to learn about the range of HIV risk behaviors in the potential participants of these studies. The probability of HIV infection associated with these risk behaviors should also be examined. This study is designed to increase the ability of HIVNET to put into place HIV prevention trials, to increase the diversity of trial participants, and to target populations at highest risk for HIV infection.
The purpose of this study is to compare the efficacy of an immersive virtual reality (VR)-based education program with a form of patient education commonly provided by clinics (e.g., an educational video) at delivering education to breast cancer patients as they prepare for radiation therapy treatment. Self-evaluation questionnaires completed by participants will be used to measure changes in information needs and anxiety, stress, preparedness and satisfaction levels pre/post education between the VR-based education and video education groups in this study. Expanded access to the current VR-based education program will depend on licensing status for associated assets by interested parties.
Nurses Taking on Readiness Measures (N-TORM) is an innovative nurse-driven household emergency preparedness intervention modeled after an existing community intervention provided by emergency management personnel. The proposed pilot studies will test the Korean translation of the Household Emergency Preparedness Instrument (K-HEPI) and describe the implementation and effectiveness of N-TORM in a community setting. The aims of this instrument translation study and cluster randomized controlled trial are to (a) field and pilot test the K-HEPI in order to perform psychometric testing on the instrument and generate reliability and validity data, (b) increase the accessibility of N-TORM to vulnerable populations, (c) evaluate the effectiveness of N-TORM to increase household emergency preparedness knowledge and behavior, (d) implement N-TORM in a community located in an area at increased risk for disasters, measuring consistency of delivery, time, and cost of N-TORM, and (e) describe the factors most necessary to maintain and expand N-TORM.
Nurses Taking On Readiness Measures (N-TORM) is an innovative nurse-driven household emergency preparedness (HEP) intervention modeled after an existing community intervention provided by emergency management personnel. This phase I feasibility pilot study will describe the implementation and effectiveness of N-TORM in the community setting, but provided by nurses. The aims of this implementation study are to: (a) increase the reach of N-TORM to vulnerable populations; (b) evaluate the effectiveness of N-TORM for increasing HEP knowledge and behavior; (c) implement N-TORM in a community located in an area at increased risk for disasters, measuring consistency of delivery, time, and cost of N-TORM; (d) describe the factors necessary to maintain and expand N-TORM, and; (e) pilot test a new HEP instrument in order to perform psychometric testing on the instrument and generate reliability and validity data.
This is a pilot study aiming to examine preliminary effectiveness of a preparation program which includes simulation (SIMDiscovery) in reducing anxiety and increasing feelings of preparedness among parents and their children who will undergo spinal fusion surgery. SIMDiscovery is an experiential learning preparation program which aims to educate children and families about different medical procedures through simulation play.
The decision making process for stress incontinence surgery is complex. A key gap in the literature is how to improve patient preparedness and satisfaction for mid-urethral sling (MUS) surgery that is reproducible and low cost. Multimedia can assist in bridging this gap. The specific aims of the proposed research: (1) is to develop two videos to counsel patients who have elected to undergo a MUS surgery. One video will be created from a patient-centered perspective using peers as counselors. The second will employ a traditional counseling approach; (2) To compare the impact of multimedia counseling between women randomized to a patient-centered counseling versus a traditional counseling video. The investigators will recruit patients who present with stress urinary incontinence who elect to undergo a MUS procedure. Women will be randomized during their pre-operative visit to watch the patient-centered or traditional counseling video before they are counseled regarding their upcoming MUS surgery in the usual manner. The investigators anticipate women randomized to a patient centered-video will report higher satisfaction, less decisional regret, greater preparedness, and less anxiety as measured by validated scales. Successful completion will improve understanding of patient's needs and will allow development of improved educational tools readily available to the AUGS community.
This trial is designed to assess immunological biomarkers measured from blood samples that can be used to reliably predict how well vaccines work against symptomatic COVID-19 as well as to evaluate the feasibility of remote, self-collected specimens when conducting a correlates analysis. For a lot of research studies, people need to go to the study doctor's office regularly. For this study, we want to see if it is okay that people do the study doctor visits virtually, fill out questionnaires electronically, and collect their own samples remotely. Participants will enroll in the study after receiving a COVID-19 vaccine in their community, and saliva and blood specimens will be collected at pre-defined timepoints over a 12-month period. Additionally, participants will report weekly whether they experience symptoms of COVID-19, and if so, will be prompted to collect a nasal swab for testing. Most participants will complete all activities remotely and via electronic communications, but a small number will complete activities in person at the doctor's office to provide a comparison group. Samples from the study will be analyzed to determine whether the biomarkers can be measured, and data from the study will be used to evaluate the feasibility of doing the specimen and data collection without the participant going to the doctor's office in person.
The goal of this clinical trial is to evaluate Kinto's Care Coaching intervention for dementia caregivers. The main questions it aims to answer are: Does the intervention help caregivers to address their general caregiving goals Does the intervention help caregivers to address their financial caregiving goals Participants will have access to: One-on-one care coaching sessions (via zoom) Up to 6 weekly support groups with other caregivers A variety of digital resources through Kinto's mobile app Researchers will compare intervention and control groups to see if the program supports caregivers' general and financial caregiving needs. The efficacy of the intervention also will be examined on key outcomes.
Compare preparedness for total laparoscopic hysterectomies between patients who undergo virtual visits and those who undergo in-office visits for pre-operative counseling.
This is a randomized controlled trial evaluating in office versus telemedicine preoperative counseling visits based on patient preparedness for surgery and patient satisfaction.