202 Clinical Trials for Various Conditions
The purpose of this study was to evaluate the GETCare program, a Goal-based Education and skills Training program for Caregivers poststroke.
Mutual goal setting and action planning in patients with long-term conditions in outpatient settings is associated with favorable effects on measures of physical health, psychological health, subjective health status, self-management self-efficacy levels, activation levels, and perceived empowerment. The purpose of this study is to examine the impact of an educational intervention delivered to the staff nurses of two surgical units on how to engage patients in mutual goal-setting in the acute care setting. Staff nurses from two 32-bed surgical units will be scheduled to attend an hour-long educational intervention. A total of 630 chart audits will be conducted one month prior and one and three months following the intervention per unit, to examine the number of patients with a daily goal recorded in the prior 24 hours and the quality of the recorded goal using the SMART-GEM. The self-efficacy of engaging in mutual goal-setting with patients will be examined by asking nurses to complete the Appraisal Inventory Tool (AIT) prior to and immediately following the intervention. The patient experience of engaging in mutual goal-setting will be examined by having a total of 165 patients complete the Patient Experience of Mutual Goal-Setting Tool (PEMGST) one month prior to the intervention and one and three months following the intervention on each of the two units.
This project will develop and refine a shared decision making (SDM) intervention (decision aid tool) to improve and normalize high quality end of life discussions in the Emergency Department (ED) setting.
This pilot intervention study will test the feasibility and acceptability and explore the outcomes of an urban, primary care-based intervention to measure families' preferences and goals for Attention-Deficit/Hyperactivity Disorder (ADHD) treatment and structure clinical care to reach these goals.
This pilot study will evaluate whether an intervention aimed at hospitalized patients with advanced lung and gastrointestinal cancers can help facilitate goals-of-care (GOC) communication with their oncologists after discharge. While GOC communication is a recommended component of routine oncology care, many patients with solid cancers do not have the opportunity to talk with their oncologist about their goals and end-of-life preferences. Prior research has shown that a systematic method of prompting GOC communication with at-risk patients would address a key barrier to timely GOC communication and ensure that patients receive care that is in line with their personal preferences. This trial will enroll 80 participants, who will be randomized 1:1 to either an intervention or a control group. Participants in the intervention group will complete a short survey regarding their goals, preferences, and disease understanding. Survey responses will be shared with each participant's outpatient oncology team. Oncologists will subsequently receive a nudge in the electronic medical record reminding them of key survey responses and encouraging them to discuss them at the patient's first clinic visit after hospital discharge. The primary feasibility outcome is intervention completion rate and the primary clinical outcome is GOC documentation within 30 days of discharge in the intervention group compared to the control group.
The goal of this clinical trial is to learn if adding patients' goals and concerns to measurement-based collaborative care can tailor care and provide a more holistic view of treatment, thereby improving engagement in care among adult patients receiving collaborative care. The main questions it aims to answer are: * Does using a clinical decision support system (which includes an enhanced pre-visit questionnaire and patient-level dashboard) improve patient engagement in the collaborative care model? * Does using a clinical decision support system improve patient and clinician satisfaction with care? Researchers will compare the enhanced collaborative care with traditional collaborative care. Patient participants will complete pre-visit questionnaires before their collaborative care appointments. Responses will be viewed by the clinician and/or patient in a visual dashboard inside the electronic health record.
This is a Phase 4, multi-center, observational study conducted in patients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa in the US and Japan. This study aims to enroll 35 patients.
The purpose of this research is to better understand how the human brain accomplishes the cognitive task of making goal-directed decisions. These investigations are critical to better understand human cognition and to design treatments for disorders of decision making and performance monitoring.
This is an optional sub-study that will enroll participants from LIFE-DSR parent protocol. The aim is to assess change over 16 months in individuals with Down syndrome through individualized goals set by their caregivers. This sub-study also aims to assess the feasibility of Goal Attainment Scaling in the DS-AD population.
To improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care.
Anhedonia, the inability to seek-out and experience pleasure, is a common symptom in depression that predicts treatment-resistance and is sometimes exacerbated by first-line antidepressants. In our previous research, we found that anhedonia decreases goal-directed behavior and its related neural activity. In this study, we will investigate target engagement from five-consecutive days of stimulation for participants that are within a unipolar major depressive episode and also have high symptoms of anhedonia.
This project will evaluate the effectiveness and mechanisms of mindfulness-based relapse prevention (MBRP) delivered via video conferencing, as compared to referral to online mutual support groups, in supporting long-term whole-person recovery and improvements in neurobiologically-informed domains of addiction among individuals with alcohol use disorder who are interested in reducing or stopping drinking. The project will also examine the reach, effectiveness, adoption, implementation, and maintenance of MBRP as an accessible and freely available continuing care option that supports long-term recovery from alcohol use disorder in all communities nationwide, including medically underserved and health professional shortage areas.
The goal of this study is to compare the impact of a SMART ((specific, measurable, attainable, realistic, or timely) Goal setting protocol on body weight, metabolic parameters (Hemoglobin A1c, lipids), diet quality and physical activity frequency in obese children with prediabetes in the outpatient setting. The main question is if participants using the SMART Goal Setting Protocol (SGSP) will have a significant reduction. The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), in BMI Z-score, A1c, and dyslipidemia in 6 months compared to controls.
This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention.
Engaging in regular physical activity during midlife is a key lifestyle behavior associated with reduced risk for Alzheimer's disease and related dementias (AD/ADRD). Yet nearly half of midlife adults (48%) do not meet national physical activity guidelines. The purpose of this mechanistic trial is to identify effective goal setting techniques to enhance psychosocial processes of self-regulation for the successful promotion of PA and adherence to national PA guidelines among midlife adults, with the long-term goal of reducing AD/ADRD risk
The overall goal of the study is to develop a novel weight loss intervention for postpartum people by providing strategies to improve sleep, diet, and physical activity behaviors. In this study, we will recruitment and enroll 40 postpartum people and randomize them to receive the Sleep GOALS intervention or education control to evaluate the intervention's feasibility, acceptability, and preliminary efficacy.
The purpose of this project is to conduct a trial to assess whether patients that receive a tablet-based waiting room priority communication tool (the "Epilepsy Visit Planner") have improved outcomes compared to patients that do not receive the tool. The project's hypotheses are: * Patients that receive the Epilepsy Visit Planner will have improved patient-provider communication compared to the non-planner group. * Patients that receive the Epilepsy Visit Planner will have improved quality of life scores. * The Epilepsy Visit Planner will score highly on process measures of feasibility and acceptability, demonstrating suitability for future larger scale study. Additionally, there is a related survey project that is not part of the clinical trial and will not be included in this registration information.
The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness.
The purpose of this study is to determine whether interaction with an adaptive Fitbit-based goal setting application can increase levels of everyday light intensity physical activity in middle-aged adults.
Our specific aim is to examine the effects of TMS on spatial processing during goal-directed navigation. In these experiments the investigators will utilize a scalp-recorded brain oscillation called right posterior theta that is believed to index the sensitivity of the parahippocampal cortex to spatial context. Here the investigators will asked whether this electrophysiological signal can be modulated up or down using TMS while participants engage in virtual navigation tasks, and if so, whether it would affect the spatial encoding of rewards and subsequent choices during task performance.
The goal of this pilot trial is to learn about the optimal intensity level of goals in a digital weight loss intervention among adults with overweight or obesity. The main questions of the study are to assess the feasibility and acceptability of different goal intensities across four domains (calorie goal, step goal, eating window goal, red zone food goal). The investigators will recruit 32 total participants to the trial. Recruitment will occur through remote channels. Interested individuals will be directed to an online screening questionnaire; those who are eligible will then be invited to attend an initial remote session with study personnel to ensure interest and eligibility in the study. The weight loss intervention will last 10 weeks, and all participants will receive a "core" treatment consisting of self-monitoring weight, food intake, and steps (all via digital tools provided by the study team), along with behavioral lessons, action plans, and tailored feedback. Depending on which group participants are assigned to in the study, individuals will receive either a more or less challenging goal across the four domains. All study tasks will occur remotely, thus, participants will never come in-person for any tasks. Assessment of body weight and other measures will occur at the beginning of the trial ("baseline"), and at 4 weeks and 10 weeks. The investigators will use the Multiphase Optimization Strategy (MOST) framework to identify which of the goal intensity levels result in meaningful engagement and weight loss. The current study is the first step towards answering this question; it is designed as a pilot factorial trial, which focuses on feasibility and acceptability. In total, there will be 16 treatment conditions.
The goal is to pilot test a highly accessible, web-based, pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogate decision-makers of patients in ICUs with severe acute brain injury (SABI), including those with moderate-severe traumatic brain injury, large hemispheric acute ischemic stroke and intracerebral hemorrhage.
To evaluate the effectiveness of the goal development intervention in guiding individual patients through the identification of high quality, specific, measurable, relevant and time-bound goal for treatment.
This is a randomized controlled trial of the Patient-Initiated Note about Goals (PING).
The Non-Invasive Cardiac Output Monitor (NICOM) is a non-invasive monitor capable of measuring cardiac output (CO) and cardiac index (CI), and stroke volume (SV) and stroke volume index (SVI) based on heart rate. Conceptually NICOM is a technology that utilizes a dynamic response characteristic in assessing the need for fluid administration, whereby SVI is measured before and after a fluid challenge with more fluid given only if SVI increases significantly with administered fluid. Dynamic response technologies are intended to replace older, "static" measures such as central venous pressure (CVP) and pulmonary capillary wedge pressures (PCWP) which are single point measurements utilized to assess the need to administer fluid. The aim is to pilot and evaluate the effectiveness of using The Non-Invasive Cardiac Output Monitor (NICOM) technology for goal-directed fluid resuscitation in adult inpatients with sepsis associated acute hypotension and/or evidence of septic shock (Lactate \>= 4.0).
The goal of this clinical trial is to improve communication among clinicians, patients with memory problems, and their family members. We are testing a way to help clinicians have better conversations to address patients' goals for their healthcare. To do this, we created a simple, short guide called the "Jumpstart Guide." The goal of this research study is to show that using this kind of guide is possible and can be helpful for patients and their families. Patients' clinicians may receive a Jumpstart Guide before the patient's clinic visit. Researchers will compare patients whose clinician received a Jumpstart Guide to patients whose clinician did not receive a guide to see if more patients in the Jumpstart Guide group had conversations about the patient's goals for their healthcare. Patients and their family members will also be asked to complete surveys after the visit with their clinician.
The purpose of this clinical trial is to investigate the causal role that frontostriatal circuitry plays in goal-directed behavior. The participants will perform a reward-based decision-making task. During the task, cross-frequency patterned rhythmic transcranial magnetic stimulation (TMS) will be delivered at delta-beta frequency, a control-frequency, or an active sham to either the dorsolateral or medial prefrontal cortex (PFC). Electroencephalography will be collected concurrent with stimulation. Structural and functional magnetic resonance imaging (MRI) will be collected during performance of the reward-based decision-making task to localize the stimulation targets.
This is a cluster-randomized controlled trial of NDPP-Flex versus the standard NDPP to evaluate effects on glycemia, heterogeneity of treatment effects, and mechanisms of change. We will recruit 200 diverse adults with prediabetes (A1C 5.7-6.4%) and normal weight or overweight/obesity. Participants will enroll in classes (N=20) that are randomized to deliver NDPP-Flex or the standard NDPP. The trial is designed to have \>95% power to detect anticipated treatment effects of \~0.2% A1C improvement and \~10% increase in participants who reach normoglycemia compared to the control arm. The study will be conducted in a health system with the 6th largest network of FQHCs in the US (Denver Health) and in partnership with a premier research institution (University of Colorado).
The investigators will conduct a pilot cluster randomized trial of Nutri, a clinical decision support software to support collaborative diet goal setting in primary care. Nutri is designed within the Chronic Care Model framework, specifically with the intention of leveraging clinical information systems to connect clinical care with patients' lives in the community setting. Nutri is based on the Theory of Planned Behavior and uses collaborative goal setting between the patient and provider to identify a behavioral intention (i.e., diet goal) and improve goal self-efficacy by improving attitudes/outcome expectations, subjective norms/social support, and perceived behavioral control. In this pilot trial, the intervention group (N=10 primary care providers \[PCPs\], N=40 patients) receives collaborative diet goal setting via Nutri, and the control group receives usual care(N=10 PCP, N=40 patients). Before and after the appointment, patients will report food they consumed over the last 24 hours via the dietary recall tool, ASA24 and respond to surveys about behavioral intention and self-efficacy. Intervention PCPs will be alerted when the Nutri workflow is available for a patient and asked to complete it during their visit with that patient.
The purpose of this study is to adapt and evaluate a combination intervention that includes: (1) a data-driven approach to directed community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART (antiretroviral therapy)Start program, all in Mobile County Health Department (MCHD) jurisdictions in Alabama.