254 Clinical Trials for Various Conditions
The purpose of the study is to determine whether a web-based nursing intervention delivered during the postpartum period will decrease symptoms of postpartum depression and parenting stress.
The goal of this experimental study is to learn if cognitive stimulation therapy (CST) helps improve cognitive functioning and engagement in individuals with mild-to-moderate dementia who reside in skilled nursing facilities. It will also help introduce CST into long-term care facilities in the Northern Kentucky region and provide evidence to support reimbursement for occupational therapy (OT) services in memory care. The main question it aims to answer is: Is there a significant difference in cognitive functioning and engagement between individuals with mild-to-moderate dementia who reside in skilled nursing facilities and receive cognitive stimulation compared to individuals receiving maintenance-level services? Researchers will compare CST (themed grouped sessions with activites related to their childhood, sounds, word and number games, current affairs, being creative, word association, physical games, quizzes, and orientation) to maintenance-level services (activities performed in the activities room) to see if there is a significant difference in cognition and engagement in residents who receive CST versus their regular maintenance level services. Participants will receive either CST or maintenance-level services for 45-minutes twice weekly for 7-weeks led by two doctor of occupational therapy students under the supervision of a licensed occupational therapist in the state of Indiana and the sites activity director, complete assessments before and after the 7-weeks to measure changes in cognitive function and engagement, along with participating in a screening assessment before the start of the study. This study will also support the OT profession by enhancing practitioners' skills in dementia care and contributing evidence for policy and reimbursement discussions.
The goal of this study is to learn if dental infection control treatment delivered to older adult nursing home residents at their place of residence will result in : * improved dental health * reduced risk of pneumonia * better glucose control for diabetic patients compared to the pre-project dental and general health evaluations of residents and the pre-project facility incidence of pneumonia. Dental infection control treatment includes treating gum infections, stopping or slowing decay with fluoride, and assisting residents with effective tooth brushing and denture cleaning daily. Previous studies indicate dental infections can be inhaled and cause pneumonia or make diabetes worse. A shortage of dentists has limited care for nursing home residents. This project will allow dental hygienists and specially trained dental assistants to treat nursing home residents using telehealth methods (computers, cameras, internet, and telephone) to talk and work with dentists in different locations.
The long-term goal of this study is to develop a mindfulness-based intervention (MBI) program to reduce stress and burnout while increasing belongingness and connectedness among faculty and staff at the University of New Mexico (UNM) College of Nursing (CON). The central hypothesis is that the MBI intervention will improve psychosocial outcomes (sense of belonging) and physiological outcomes (heart rate variability, HRV) among CON faculty and staff. The specific aims are to: Aim 1: Evaluate the feasibility and acceptability of MBIs (meditation or yoga) through participant interviews, recruitment, retention, and adherence rates. Aim 2: Assess the preliminary effects of MBIs on psychosocial (burnout, stress, anxiety, sense of belonging) and physiological (HRV) outcomes. The hypothesis predicts improvements in both psychosocial and physiological measures post-intervention. Researchers will compare meditation to yoga to see if one improves psychosocial and physiological outcomes better that the other. Participants will be asked to: * participate in meditation or yoga two times per week * complete surveys * use an app on their phone to answer short surveys * wear a smart device
This clinical trial will evaluate the effectivness of an Eastern Principles Acceptance and Commitment Therapy intervention (EPACT) relative to an estabished traditional Western-based Acceptance and Commitment Therapy intervention (ACT) and a no treatment control group. The participants for the study will be nurses and nursing aides (NNAs) who work in long-term care settings in the USA and Thailand. The primary dependent variables are work-related injuries, work stress and burnout, wellbeing, musculoskeletal symptoms, time off from work due to injury. High frequency heart rate variability will also be investigated as a predictor of responsiveness to the interventions. The study has three primary aims: 1. To compare the EPACT NNA intervention to an established traditional Western ACT NNA intervention and a no-treatment control group. 2. To identify predictors of ACT NNA and EPACT NNA responsiveness to the interventions and injury likelihood across time. 3. To assess EPACT NNA's feasibility and effectiveness across cultures. USA participants working in Ohio will be randomly assigned to one of three groups: EPACT NNA (n = 80), ACT NNA (n = 80), or a no treatment control group (n = 80). All participants will participate in an assessment session where study questnnaires are completed and a baseline high frequency HRV measurement is collected. Subsequent to the assessment, the EPACT NNA and ACT NNA participants will attend two 2.5 hour sessions spaced one week apart. The control group will have no further in-person meetings with the researchers. One-month after completing the intervention (4 weeks after the baseline assessment) a follow-up survey will be sent to participants for the first follow-up. Three months after baseline, the second follow-up survey will be sent to participants. The surveys assess demographic characteristics, organizational variables, work-related injuries, work stress, and well-being. A second RCT study will be conducted in Thailand comparing EPACT NNA (n = 40) to a no-treatment control group (n = 40) among nurses and nursing aides working in healthcare settings. The same outcome measures and procedures will be used. This research aims to develop a culturally-informed, evidence-based intervention that integrates both Western and Eastern mindfulness principles to address the high rates of work-related injuries among NNAs.
This pilot study will explore the use of the BioIntellisense BioButton, a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy.
The purpose of this study is to explore the effect of sedative and stimulative music listening on physiological responses among nursing students.
The goal of this clinical trial is to find out if immediate (hot) or delayed (cold) debriefing is better for undergraduate nursing students during Basic Life Support (BLS) training. The study aims to: * Identify the effect of hot versus cold debriefing in BLS training for nursing students. * Identify which debriefing method students prefer. Researchers will compare the two debriefing methods. Participants will: * Be randomly assigned (by flipping a coin) to either hot or cold debriefing. * Take part in a simulation about Basic Life Support.
The purpose of this study is to test a person-centered, nature-based non-pharmacological intervention for nursing home residents living with dementia who exhibit persistent vocalizations. The Environmental And Sensory Experience (EASE) involves the projection of a still nature image and the playing of nature sounds. Family members of the person living with dementia provide consent for the resident to participate in the study and complete a brief survey on nature preferences on the resident's behalf. The survey informs the research team on what nature scene to show. Participants will wear a watch that measures stress levels and research staff will monitor vocalization patterns. We will also recruit persons living with dementia from other settings such as assisted living, personal care units, and adult day care settings.
Skilled Nursing Facility at Home is a multicenter randomized control trial that aims to evaluate a home-based model of providing post-acute care (PAC). We will enroll 650 hospitalized patients who require rehabilitation and/or skilled-nursing support upon discharge and randomly assign them to an intervention (home-based PAC) or control arm (facility-based PAC). Our design includes two different health systems in Massachusetts: Baystate Health and UMass Memorial Health. We will perform 1:1 randomization between the intervention and control arm using a permuted block design, with stratification by clinical site and payor group. The primary outcome of the trial will be the difference in hospital readmission and mortality rates from the time of enrollment to 30 days after enrollment. Secondary clinical, functional, and cost outcomes include length of stay in PAC, difference in health-related quality of life (HRQoL), and healthcare cost and utilization.
We will perform a parallel-group multicenter patient-level randomized controlled evaluation of skilled nursing facility care at home. Patients typically referred to a skilled nursing facility following hospitalization will be eligible for enrollment. Instead of admission to a skilled nursing facility, participants will receive care from a technology-enabled team in their own homes or will be allocated to receive care in a traditional skilled nursing facility setting.
The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation.
The goal of this clinical trial is to compare three care models for optimizing medications and preventing falls with broken bones in patients receiving rehabilitation after a hospitalization for a broken bone. The primary outcome is injurious falls, with secondary outcomes measuring how the process of care is changed and capturing patient-reported outcomes valued by stakeholders. The main questions this study aims to answer are: * Which of the three models is more effective in preventing falls with fractures? * What are the differences in patient-centered outcomes amongst the three models? These include pain, depression, anxiety, sleep, medication side effect burden, and fear of falling. * What are the differences in osteoporosis treatment and medication burden? The three care models are: a Deprescribing Care Model designed to reduce or stop fall-related medications, a Bone Heath Service Model designed to provide osteoporosis evaluation and management, and an Injury Prevention Service Model offering both services. 42 SNFs will participate in this study. The three models will be incorporated into the routine care of patients at these facilities who are receiving rehabilitation after a hospitalization for a fracture. All care models will be delivered remotely to patients in the SNF and after they transition home by a post-fracture nurse consultant supported by an interprofessional team. This study has three aims. See Detailed Description for more details. This ClinicalTrials.gov record represents the Comparative Effectiveness Aim of the protocol.
Social isolation is an emerging critical challenge in the care of older adults. Nursing home residents engage for an average of just 12 minutes per day with an activity director, a situation further exacerbated by Covid-19. Social isolation has detrimental effects on health, evidenced by 48.7% of nursing home residents with an active depression diagnosis, and 61% have moderate or severe cognitive impairment. The ultimate goal of this project is to alleviate older adults loneliness and boredom and to improve their mood in an economically feasible and scalable way. The investigators will integrate the existing Vigorous Mind (VM) multidomain activities platform for older adults with an affordable autonomous navigating robot to remotely socialize with and engage long-term-care facility (Facility) residents diagnosed with Mild Cognitive Impairment (MCI) or early-stage Alzheimer s disease or related dementias (Residents). The VM web-based platform has been used for group activities in senior living facilities for eight years. A Resident s profile in VM automatically searches the web and presents their favorite music, reminiscence content, comedy, and personalized brain exercises. VM is secure and HIPAA compliant. A VM employee (VM Companion) with experience running activities in a long-term care facility will be introduced by the staff to a Resident as a new companion who will visit the Resident through the robot to keep them company. The temi robot can be instructed to go to room 312 and it will navigate its way to the room. The Resident will be notified that the VM Companion is arriving for a visit, and once in the room, the VM Companion will see and greet the Resident, and the Resident will see the VM Companion. Since the VM Companion has dashboard access to the Resident s background and interests via the VM profile, they will be able to meaningfully socialize and engage in relevant VM activities. The goal of this Phase I project is to test the feasibility of this idea and to collect preliminary data on its effect on loneliness and mood.
Pressure injuries, local areas of damage to the skin and underlying soft tissue that are costly and painful, are often preventable with timely use of prevention strategies. Identifying early pressure induced tissue damage among nursing home residents by nursing staff during routine skin assessment is critical for this process. Finding early damage can prompt nursing home staff to start prevention actions and may allow viable tissue rescue, reducing other health problems or death. We propose use of sub-epidermal moisture (SEM) measures as the cue for nursing home staff to start prevention care. SEM provides early detection of skin damage by as much as 5 to 10 days prior to other methods, eliminates the inherent structural bias in visual skin assessment for residents with dark skin tones, and demonstrates a model of care using technology innovation in poorly-resourced healthcare settings to provide bedside, real-time, point-of-care feedback that is can be used immediately by nursing staff. In this study, nursing staff will use a device (the Provizio SEM Scanner) as part of standard skin assessments. The staff will use the values from the Provizio SEM Scanner during these assessments to decide if residents need preventive care for their skin. The study will look at these decisions and residents' subsequent health outcomes. The study will also use information about residents' skin health and prevention actions during the 52 weeks before the study as a comparison.
Since the "National Partnership to Improve Dementia Care" debuted in 2012, almost all long-stay psychoactive prescribing has been graded by CMS, which has correlated to decreased use. However, some national data suggest that while these psychoactive medications are being used less, prescriptions of mood-stabilizing antiepileptic drugs (AEDs) have increased. Unlike all other psychoactive medications, AEDs prescribed in nursing homes are not mandatorily reported to CMS or graded in a quality-measure.
Pain is common amongst people living with dementia. However, as people's dementia worsens their ability to self-report pain diminishes because of limitations in their cognition and communication abilities. As a result pain in people with moderate to severe dementia often goes under-recognised and undertreated. PainChek® is a technology-enabled, observational pain assessment tool, in the form of a mobile application designed specifically to assist healthcare professionals and professional caregivers assess pain in people with moderate severe dementia. In this study the investigators aim to assess the performance of PainChek® in assessing pain in nursing home residents with moderate to severe dementia compared to the Abbey Pain Scale.
The goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.
This proposed study seeks to develop a smart ambient bright light (SABL) intervention to provide auto-controlled, consistent indoor lighting that incorporates natural daylight. This SABL includes tunable LED lights, photosensors, and controllers. The SABL system has a pre-programmed 24-hour control schedule for illuminance settings to mimic the natural bright-dark cycle. It will automatically adjust the lights to accommodate the daylight effect to minimize staff burden and maximize the LI effect. The SABL will be installed in participants' bedrooms and designated areas in the dining rooms and activity rooms for four weeks. Each participant will wear a personal light monitor to measure the lighting dosage each participant receives. This study will address three aims: 1) pilot test the effect of SABL on reducing agitation in persons with ADRD, 2) evaluate the fidelity of the SABL delivery, and 3) evaluate the feasibility of implementing the SABL. The study will be conducted in two NHs in Pennsylvania. For aims 1 and 2, the investigators will use a crossover, cluster randomized control trial (RCT) and will enroll residents with ADRD and agitation. For aim 3, the investigators will use a mixed methods design and will interview NH stakeholders to evaluate the acceptability, feasibility, and appropriateness of the intervention. This is the first study that incorporates daylight in ambient light interventions and the first study that addresses the measurement, feasibility, and fidelity of lighting interventions. Findings will establish evidence-based implementation strategies and the best design for SABL to reduce agitation for persons with ADRD in NHs.
This study seeks to improve clinical outcomes for an important, growing, and vulnerable population-nursing home residents with Alzheimer's disease or related dementias-by testing an evidence-based intervention to improve these residents' sleep. It will also examine the implementation and sustainment of this intervention.
Background: Nightshift health care employees can experience greater likelihood of health threats such as weight gain, hypertension, and sleep disturbances. Evidence indicates a willingness of nightshift health care professionals to engage in wellness activities initiated at the work setting and during the assigned nightshift. In this single site study at a freestanding pediatric tertiary care hospital, inpatient units will be randomized to one of two nightshift interventions during an 8-week study period (mindfulness plus sleep hygiene or physical activity plus sleep hygiene). Immediately following the first study period, the randomized units will begin a second study period in which they will continue with the intervention first received but shall add the intervention not initially received. While there are hundreds of studies that describe the adverse health and safety effects of night shift work, there are few studies where interventions are tested for their efficacy to reduce the harm to workers or improve their well-being. Currently the few intervention studies that exist focus on the scheduling, duration and timing of work shifts, the timing of meals, and aspects of lighting in the workplace. Other interventions, such as those proposed in this study, have not been tested systematically using a rigorous design. Purpose and Methods: The purpose of this study, using a cluster cross-over randomized trial design, is to measure the impact on professional quality of life (primary endpoint) and medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention plus sleep hygiene (Arm A) or a physical activity intervention plus sleep hygiene (Arm B) in the first study period, and the combination of both interventions on the same outcomes in the second study period for nightshift health care employees.
The goal of this intervention study is to compare two different simulation modalities (standardized patient and manikin-based) in nursing student education. The main aim is to determine the effect of new scenarios on cultural awareness levels in two different types of simulation modalities and to determine the effect of new scenarios on social determinants of health knowledge levels in two different types of simulation modalities. Participants will assign to two groups and will attend simulation sessions.
The purpose of this study is to adapt, pilot test, and evaluate the feasibility, acceptability, and preliminary effectiveness of DIGNITY (Decision-making In aGing and demeNtIa for auTonomY) for Preference-Based Care in Nursing Homes as a new evidence-based intervention to support nursing home staff to safely honor care and activity preferences of residents' living with dementia in rural, typically under resourced nursing home communities.
In prior work, this research team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. Researchers will test the TIPC intervention to assess palliative care (PC) support for patients with chronic obstructive pulmonary disease (COPD) among a population of urban-dwelling, African American (AA) persons over the course of 15 months. The aims of this study are to 1) evaluate patient, caregiver, and clinical team perspectives of feasibility and acceptability of the TIPC model with urban-dwelling AAs with advanced COPD, and 2) explore the impact of TIPC intervention on knowledge and completion of advanced care planning (ACP) and on hospice and healthcare utilization patterns in the target population, as well as on additional quality of life (QOL) endpoints, and compare these between individuals participating in the intervention group and control group.
This study is examining the effect of listening to music on personal variables such as stress, anxiety, and academic performance. Previous research has shown that listening to music can help in reducing the effects of anxiety and stress.
This cluster randomized clinical trial seeks to provide large-scale, foundational evidence that high-intensity rehabilitation is effective and can be systematically implemented to improve functional outcomes for patients admitted to skilled nursing facilities following hospitalization. Additionally, this study will generate a descriptive overview of factors that predict implementation success while informing effective implementation strategies for future skilled nursing facilities innovation.
Nursing students (N=32) will be randomized to begin period 1 in either a high-fidelity or low-fidelity simulated experience with a mock patient wearing a breast model and holding a newborn simulator and then cross over in period 2 to the opposite arm. Data on student satisfaction, engagement, self-efficacy, and performance and simulator fidelity will be collected via Qualtrics surveys (defined, 6-point Likert scale), written and oral reflection, audio-video recordings of clinical lactation encounter, and clinical lactation skills checklists and global performance ratings. Nursing students in the accelerated master's program will be recruited while completing their required simulation coursework. A random number generator will be used to randomly assign students to a treatment arm. Investigators will require at least 8 students per arm (power 80%, alpha 5%). Investigators will recruit 32 students for two study dates to compare the high-fidelity LiquidGoldConcept products to two competitor products. The Johns Hopkins School of Nursing and Simulation Center will be the only sites where human subjects research will be performed. The collaborating investigators (Drs. Debbie Busch, Joanne Silbert-Flagg, and Nancy Sullivan) have expertise in clinical lactation education and simulation. With the collaborating investigators LiquidGoldConcept has already completed pilot studies to establish the feasibility of our approach and validate the survey instruments.
The COVID-19 pandemic ravaged United States skilled-nursing facilities (SNFs). Novel strategies that maximize the safety and quality of life for SNF residents with ADRD and staff who care for them are urgently needed. Thus, the study's objectives are: 1. To rapidly plan and pilot test an intervention that leverages COVID-19 antibody and PCR status to pair SNF staff with residents in the safest way possible 2. To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.
This study is a mixed-method exploratory study with the aim to determine an objective compensation or mechanism of support from a healthcare system standpoint to aid in retention of nursing staff amidst the ongoing COVID-19 pandemic. It will include semi-structured qualitative interviews of current and prior nursing staff from the Trauma/Surgical floor, Progressive Care Unit, and ICU, in addition to Trauma/Surgical unit and system administrators; the second portion of the study will include a quantitative survey distributed via email to current nurses on the Trauma/Surgical floor, Progressive Care Unit, and ICU to assess ranked priority of additional mechanisms of support to improve intention of retention.
The Pharmacy Integrated Transitions (PIT) program, utilizes a crossover randomized control design to evaluate the impact of a clinical pharmacist in decreasing medication related problems during a patient's transition from hospital to skilled nursing facility (SNF).