[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"informal-caregivers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:informal-caregivers":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100561314","improving-needs-among-older-adults-100561314",false,"NCT06588556","Improving Needs Among Older Adults","Improving Needs Among Older Adults: the ICUconnect 2 Primary Palliative Care RCT","ICUconnect 2","Inclusion Criteria:\n\nPatients (who are not interviewed but whose characteristics prompt enrollment of family members)\n\n1. Adult aged ≥18 years\n2. Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU\n3. Serious acute illness associated with a need for invasive mechanical ventilation\n4. ICU team expect patient to require mechanical ventilation for 2 or more days\n\nFamily members\n\n1. Adult aged ≥18 years\n2. Family member: self-described as the individual (related or unrelated) who provides the most support and with whom the eligible patient has a significant relationship (Society of Critical Care Medicine definition of family; Davidson J, et al. Crit Care Med, 45:103-128; 2017)\n\nICU clinicians\n\n1. Adult aged ≥18 years\n2. ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent\n\nExclusion Criteria:\n\nPatients\n\n1. Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely\n2. Palliative care consultative team and\u002For palliative care specialists are currently involved in the patient's care.\n\n   Rationale: this would dilute the intervention's effect.\n3. ICU length of stay \\>4 days during current ICU admission. Rationale: this would dilute intervention effect by widening the timeframe of family-clinician interactions and limiting standardization.\n\n6\\. Imprisoned person. Rationale: this is a vulnerable population.\n\nFamily members\n\n1. Low palliative care need burden (i.e., NEST scale score \\\u003C15) at baseline. Rationale: if there are very low baseline needs, the intervention cannot impact the primary outcome measure (i.e., NEST).\n2. Lack of English or Spanish fluency, operationalized as need for a translator to understand medical forms or participate in medical discussions.\n\n   Rationale: the app has not been translated into other languages; also, many outcome measures aren't validated in languages other than English and Spanish.\n3. Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of baseline data collection.\n\n   Rationale: this indicates a serious level of distress that will require professional assistance beyond that provided by the intervention (or control).\n4. Patient regains decisional capacity after informed consent but before the first family meeting. Rationale: as in our past ICU-based studies, this circumstance (the entry of the patient as a decision maker), would substantially change the nature of the interactions of family members and clinicians.\n5. The ICU clinician changes from a consented clinician to a non-consented clinician before the first family meeting. Rationale: in this circumstance the intervention cannot be fully deployed.\n\nICU clinicians None","ALL","18 Years",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"NA","Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect. ICUconnect facilitates families' and patients' self-report of actual palliative care needs across all core domains of palliative care quality, provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care, and provides a variety of informational supports relevant to each user's role. In this RCT, the investigators will test ICUconnect vs. usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population (Duke, Medical University of South Carolina, University of Alabama at Birmingham, Columbia).\n\nThe specific aims are to: (1) Test the efficacy of ICUconnect vs. usual care control in improving palliative care needs and other person-centered outcomes including psychological distress, (2) Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach, and (3) Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data.",[27,28,29,30,31],"Critical Illness","Palliative Care","Older Adults","Informal Caregivers","Care Delivery Model","RECRUITING","2026-03-04",{"date":35,"type":36},"2026-03-06","ACTUAL",{"date":38,"type":36},"2025-09-16",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"Duke University","OTHER",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100517156","biomechanical-validation-of-the-catt-100517156","NCT06013878","Biomechanical Validation of the CATT","Biomechanical Validation of the Caregiver Assisted Transfer Technique Instrument","Inclusion Criteria:\n\nIndividuals who use assistance with transfers and their caregivers will be recruited for this study.\n\nCaregiver participants will be included in the study if they meet the following criteria:\n\n1. at least 18 years old\n2. routinely provide transfer assistance to an adult with a physical disability\n3. serving as a caregiver for at least 3 months\n4. no formal didactic or structured training on assisted transfer techniques received as part of a professional degree or training program\n\nCare recipient participants will be included in the study if they meet the following criteria:\n\n1. at least 18 years old,\n2. has a physical disability diagnosis for at least one year\n3. requires assistance with transfers\n4. currently receives care from an informal caregiver\n\nExclusion Criteria:\n\nCaregiver participants will be excluded if they:\n\n1\\) have a current or recent history of back, neck, or other type of musculoskeletal injury within the last 6 months that would be exacerbated by performing an assisted transfer\n\nCare recipient participants will be excluded if they:\n\n1. have existing pressure ulcers or a recent history of pressure ulcers within the last 3 months\n2. have any recent upper extremity injuries (within the last 6 months) that could be exacerbated by being transferred",{"count":53,"type":21},160,"OBSERVATIONAL","As of 2020, 53 million Americans provide unpaid care to an individual with a disability. One commonly performed activity of daily living (ADL) provided by informal caregivers is assisted transfers, which requires moving an individual from one surface to another. Approximately 94% of informal caregivers who assist with ADLs to persons with adult-onset chronic physical disabilities affecting mobility reported musculoskeletal discomfort, with pain and discomfort made worse by performing caregiving activities. Although many informal caregivers assist with transfers, most have never received any formal training in proper manual lifting or mechanical lifting techniques. Improper transfer techniques can be detrimental to not only caregiver health but also to the persons they assist resulting in shoulder injury, bruising and pain from manual lift techniques, hip fractures from falls, and skin tears from shear force that occurs with sliding during transfers. Current standard of care provides limited in-person training of caregivers, as most of the rehabilitation process is client-focused. When training is provided clinicians have no means to objectively evaluate if proper techniques are being performed at discharge or when the caregiver and care recipient return home. For this reason, an outcome measure called the Caregiver Assisted Transfer Technique Instrument (CATT) was developed to provide a quick, objective way to evaluate proper technique of caregivers who provide transfer assistance to individuals with disabilities. The CATT evaluates the caregiver's performance on setup, quality of the task performance, and results. After a formal assessment through stakeholder review involving clinicians, informal caregivers, and individuals with physical disabilities who require transfer assistance, the CATT was expanded to include two versions; one that evaluates manual lift technique (CATT-M) and one that evaluates mechanical lift techniques (CATT-L). However, the CATT must undergo further testing with informal caregivers and the individuals they assist to determine if the CATT is a reliable, valid, and responsive tool for identifying skill deficits in caregivers performing assisted transfers. The purpose of this study is to establish the psychometric properties (reliability, validity, and responsiveness) of the CATT and to evaluate the effects of an individualized training session for participants who have transfer technique deficits as identified by the CATT. The long-term goal of this research is to develop the CATT so that it can be used as an objective indicator of transfer performance as well as guide training and educational interventions for informal caregivers to reduce the risk of musculoskeletal pain and injury associated with assisted transfers.",[30,57,58],"Low Back Pain","Biomechanics",[60,61,62,63,64],"caregivers","outcome assessment, health care","wheelchairs","physical medicine and rehabilitation","moving and lifting patients","2025-07-29",{"date":67,"type":36},"2025-07-30",{"date":69,"type":36},"2024-07-24",{"date":71,"type":21},"2026-10-31",{"name":73,"class":74},"VA Office of Research and Development","FED",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100579141","comparison-of-the-effectiveness-of-high-fidelity-simulation-and-low-fidelity-simulation-in-active-external-bleeding-control-management-of-caregivers-of-elderly-individuals-100579141","NCT06820437","Comparison of the Effectiveness of High Fidelity Simulation and Low Fidelity Simulation in Active External Bleeding Control Management of Caregivers of Elderly Individuals","Comparison of the Effectiveness of High-Fidelity Simulation and Low-Fidelity Simulation in the Management of Active External Bleeding Control by Caregivers of Elderly Individuals","Inclusion Criteria:\n\n* Not having received the theoretical first assessment and first aid training in external bleeding\n* No cognitive and communication problems that can actively participate in the study\n* Not being a health professional\n* Not being a paid caregiver\n\nExclusion Criteria:\n\n* The participant declares that he\u002Fshe wants to leave at any stage of the study\n* Not participating in any of the simulation phases\n* Not participating in the implementation of the data collection tools to be applied",true,{"count":85,"type":21},30,"The elderly population is increasing worldwide. Due to the increase in the elderly population, emergencies related to ageing are also encountered more frequently. One of these emergencies is trauma in the elderly. Traumas are frequently seen in elderly individuals due to physiological deficiencies related to aging as well as environmental factors. External bleeding caused by trauma is also encountered. If first aid to stop active external bleeding is not administered in a timely and correct manner, death due to bleeding can occur. Nowadays, elderly individuals live either with their families, alone, or in institutions. In the event of external bleeding, either the individual themselves, caregiving family members, or staff at the institution should be able to perform first aid to stop the bleeding.\n\nElderly individuals may not be able to perform first aid due to cognitive and neurological deficiencies. The ability of caregivers to provide first aid can be life-saving. If caregivers of elderly individuals are trained in first aid for external bleeding, they can quickly and correctly administer first aid to stop the bleeding. First aid training often consists of didactic education and demonstrations. A training strategy that ensures knowledge retention and skill acquisition is simulation training. This study aims to evaluate and compare the effectiveness of high-fidelity simulation and low-fidelity (Visually Enhanced Mental Simulation - VEMS) simulation in the skills of caregivers for elderly individuals in managing active external bleeding control.\n\nThe population of the study will consist of non-health professional caregivers of elderly individuals living in Antakya district of Hatay province. The sample size, calculated using the G Power program, has been determined to include 30 caregivers of elderly individuals. The study consists of four main work packages. In the first stage, the simulation environment will be prepared, and in the second stage, a preliminary application of the project will be conducted. In the third stage, the implementation of the research and the completion of checklists will be ensured. For this, volunteer caregivers of elderly individuals will be identified. After theoretical training is given to the participants, they will be assigned to intervention group 1 (VEMS) and intervention group 2 (high-fidelity simulation) using simple randomization. Following a pre-assessment with low-fidelity simulation, participants will undergo simulation training according to their intervention groups. Subsequently, a final assessment will be conducted using the same lowfidelity simulation. In the final stage, data analysis and interpretation of the findings will be carried out. The collected data will be analyzed statistically, and the significance level will be accepted as p\\\u003C0.05. With this study, insight will be provided into the effectiveness of VEMS and high-fidelity simulation in first aid training for active external bleeding for caregivers of elderly individuals. On the other hand, it is planned that the project results will be published in at least one article in journals indexed in the SSCI Expanded.",[88,89,90,30,91,92],"Simulation Training","High Fidelity Simulation Training","First Aid","Elderly","Bleeding",[94,95,96,97,98,99,100],"Elderly caregivers","external bleeding","elderly","first aid training","simulation","visually enhanced mental simulation","high fidelity simulation","NOT_YET_RECRUITING","2025-02-05",{"date":104,"type":36},"2025-02-11",{"date":106,"type":21},"2025-02-20",{"date":108,"type":21},"2025-08-20",{"name":110,"class":43},"Mustafa Kemal University",2]