[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"family-centered-care\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:family-centered-care":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,83,108,134,164,184,213,235],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100520546","close-collaboration-and-discharge-readiness-100520546",false,"NCT06057974","Close Collaboration and Discharge Readiness","Effects of the Close Collaboration With Parents Intervention on Parents of Newborns","Inclusion Criteria:\n\n* Infants who have been admitted to the NICU for 2 weeks or longer\n\nExclusion Criteria:\n\n* Infants whose parent doesn't have Japanese as their mother tongue\n* Infants whose parent needs psychiatric consultation after birth","ALL",{"count":18,"type":19},60,"ESTIMATED","OBSERVATIONAL","This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). We focus on (1) family centered care of the NICU rated by parents, (2) parental anxiety symptoms, and (3) their discharge readiness.\n\nThe intervention is planned to be implemented between December 2023 and December 2024.\n\nThe investigators will collect data from parents whose newborns are admitted to the NICU before and after the intervention and compare the two groups. In most cases, the parents of the two groups belong to different cohorts.",[23],"Family Centered Care",[25,26,27],"Staff education","Parental anxiety","Parental discharge readiness","RECRUITING","2026-04-07",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":32},"2023-09-28",{"date":36,"type":19},"2026-12-31",{"name":38,"class":39},"Nagano Children's Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":64,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100561160","the-family-icu-trial-100561160","NCT06586541","The Family-ICU Trial","Family Participation in Intensive Care Unit Rounds (The Family-ICU Trial)","Family-ICU","Inclusion Criteria:\n\n* Adult family members (age ≥ 18 years) of ICU patients\n* Expected ICU stay ≥ 48 hours\n* Family members wishing to participate in rounds virtually must have the technological capability and understanding to participate virtually (must have a phone or computer with internet and audio\u002Fvideo capabilities)\n\nExclusion Criteria:\n\n* Family members who do not wish to participate in care\n* Repeat admissions within the study period\n* Another family member has already participated in the study","18 Years",{"count":51,"type":19},194,"INTERVENTIONAL",[54],"NA","Family inclusion in adult intensive care unit (ICU) rounds is recommended by critical care professional societies, yet widespread uptake of this practice is limited. A key barrier cited by ICU clinicians is insufficient evidence to support this practice. There is a need for robust evidence to support family participation in adult ICU rounds and influence change to routine clinical care. The primary purpose of this study is to assess whether family participation in adult ICU rounds improves family engagement in care. The secondary objectives are to assess family satisfaction, and anxiety and depression, to explore user experiences of family participation in ICU rounds, and to evaluate strategies to improve family member recruitment and retention rates. This is a stepped-wedge cluster randomized trial (n=194) at 6 Canadian ICUs. The stepped wedge cluster randomized trial is a pragmatic study design that overcomes methodological limitations in evaluating a healthcare service delivery intervention. In the stepped-wedge cluster design, there is random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The stepped-wedge design also allows each site to function as its own control. The stepped-wedge design is more powerful than a parallel design when substantial cluster level effects are present.",[57,58,59,60,61,62,63],"Virtual Care","Family Engagement","Patient and Family Engagement","Health Care Delivery","Family-centered Care","Physician Rounds","Critical Care, Intensive Care",[65,66,58,67,68,69,70,71,72,62],"Patient- and Family-Centered","Patient- and Family-Centered Care","Critical Care","Intensive Care Unit","Person-Centered Care","Delivery of Health Care","Virtual Rounds","Family Participation in Rounds","2026-03-25",{"date":75,"type":32},"2026-03-31",{"date":77,"type":32},"2024-11-18",{"date":79,"type":19},"2029-07",{"name":81,"class":39},"Lady Davis Institute",2,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":52,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":82},"100620998","effectiveness-of-family-integrated-newborn-care-to-improve-outcomes-for-preterm-and-low-birth-weight-neonates-100620998","NCT07364903","Effectiveness of Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates","Effectiveness of Implementing Family-Integrated Newborn Care to Improve Outcomes for Preterm and Low-birth-weight Neonates in Resource-limited Settings; Quasi-experimental Design","FINC","Inclusion Criteria:\n\n* All neonates aged 0-28 days admitted to level-2 NCUs in the neonatal care unit, including Kangaroo Mother care ward or mothers' side ward, with conditions that require hospital stay at 48 hours; and\n* accompanied by at least one parent (preferably a mother) dedicated to spending up to 8 hours per day with the infant\n\nExclusion Criteria:\n\n* Neonates with major congenital anomalies\n* Infants with no family member to accompany the infant, or who do not consent to spend up to 8 hours per day in the NCU\n* Families with confirmed physical and\u002For mental problems limiting their capability to communicate and to engage, or those who leave against medical advice",{"count":92,"type":19},1020,[54],"The goal of this quasi-experimental study is to learn if integrating family in newborn care units as a key partner can improve the outcomes of preterm and low-birth-weight neonates. The main question\\[s\\] that the study aims to answer:\n\n• Does the implementation of the FINC intervention impact the neonatal outcomes for preterm and low-birth weight neonates in NCUs in resource-limited settings of Tigray, Northern Ethiopia? Researchers will compare the Length of hospital stay among preterm and low-birth-weight neonates admitted to hospitals included in the intervention groups and compared to the neonates admitted to hospitals in the control group.\n\nIn the intervention groups, family of preterm and low-birth-weight neonates will be trained, mentored, and integrated into the care targeted to their neonates.",[96,61,97,98],"Family Involvement\u002FEmpowerment","Intensive Care Units, Neonatal","Family Integrated Newborn Care","2026-01-18",{"date":101,"type":32},"2026-01-23",{"date":103,"type":32},"2025-12-16",{"date":105,"type":19},"2026-06-16",{"name":107,"class":39},"Laerdal Foundation",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":52,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":40},"100608456","effects-of-early-physiotherapy-program-on-the-infants-in-nicu-100608456","NCT07201792","Effects of Early Physiotherapy Program on the Infants in NICU","Effects of Early Physiotherapy Program on the Infants in the Neonatal Intensive Care Unit: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Newborns diagnosed with periventricular hemorrhage (PVH), intracranial hemorrhage (ICH), cystic PVL, HIE, kernicterus, perinatal asphyxia, neonatal sepsis, necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), RDS, or BPD.\n* Newborns receiving oxygen or mechanical ventilation (MV) support.\n* Infants with a 5-minute Apgar score \\\u003C3, \\\u003C37 weeks' gestation, \\\u003C1500 g preterm, or prematurity due to multiple births.\n\nExclusion Criteria:\n\n* Newborns with congenital malformations (spina bifida, congenital muscular torticollis, arthrogryposis multiplex congenita, etc.), babies diagnosed with metabolic and genetic diseases (down syndrome, spinal muscular atrophy, duchenne muscular dystrophy, etc.)","28 Weeks","42 Weeks",{"count":118,"type":19},100,[54],"High-risk of Infants are defined as one with a history of negative environmental and biological factors that could lead to neuromotor developmental problems. This heterogeneous group encompasses premature babies born at less than 37 weeks, term babies with low birth weight (LBW), or babies with developmental delays due to various causes.Studies have highlighted that individual developmental care, family education, kangaroo care, and early physiotherapy approaches applied to at-risk infants in the neonatal intensive care unit (NICU) enhance infant development. However, further research is needed to determine the most effective interventions for infants who are more environmentally at risk and biologically vulnerable. Studies investigating the effectiveness of early intervention methods initiated in the NICU on the motor, cognitive, and behavioral outcomes of premature infants have highlighted that postural control interventions or physiotherapy consisting of developmental care programs implemented in the neonatal period improve motor development in the short term, but parent-implemented motor interventions are more effective in improving infants' cognitive and motor outcomes in the long term.The aim of this study is to examine the effects of family-based early physiotherapy approaches applied to at-risk infants in the NICU on motor, cognitive, language development and developmental outcomes at term age and in the long term (adjusted 3, 6, 9, 12 months).",[122,123,124,23],"Infants Admitted to Neonatal Units","NICU","NICU Infants","2025-09-23",{"date":127,"type":32},"2025-10-01",{"date":129,"type":32},"2025-09-15",{"date":131,"type":19},"2026-08-30",{"name":133,"class":39},"Kahramanmaras Sutcu Imam University",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":52,"phases":144,"briefSummary":145,"conditions":146,"keywords":151,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":82},"100591772","the-family-cares-trial-100591772","NCT06984770","The Family Cares Trial","Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)","Family Cares","Inclusion Criteria:\n\n* (1) Family member of a person admitted to an ICU for \\>48 hours and survived to hospital discharge. \"Family\" is anyone with a biological, legal, or emotional relationship with the patient and whom the patient wants involved in their care\n* (2) Planned or current part or full-time caregiver of the ICU survivor\n* (3) Age ≥ 18 years\n* (4) Within 6 months of ICU survivor's hospital discharge.\n\nExclusion Criteria:\n\n* (1) Another family member participating in the study\n* (2) Inability to communicate in English or French.",true,{"count":18,"type":19},[54],"The goal of this pilot study is to learn if virtual peer support groups and strengths-based skills training can help family caregivers of ICU survivors providing ongoing support to ICU survivors after hospital discharge. The main question it aims to answer is:\n\n\\- Are virtual peer support groups and\u002For strengths-based skills support feasible and acceptable for family caregivers of ICU survivors? Researchers will compare the intervention group (virtual peer support groups or strengths-based skills training) to the control group (no intervention) to see if the interventions improve caregiver outcomes and assess feasibility and acceptability.\n\nParticipants will:\n\n* Participate in either virtual peer support groups or strengths-based skills training sessions (if assigned to the intervention arm).\n* Provide feedback on the feasibility and acceptability of the interventions (if assigned to the intervention arm).\n* Complete surveys and follow-up questionnaires (either online or by phone) to measure outcomes.",[58,63,59,60,61,147,148,149,150],"Pilot Study","Caregiver","Caregiver Burden","Family Caregivers",[66,58,67,68,69,70,152,153,154],"Post-ICU","Caregivers","Family Caregiver","NOT_YET_RECRUITING","2025-05-14",{"date":158,"type":32},"2025-05-22",{"date":160,"type":19},"2025-08",{"date":162,"type":19},"2027-08",{"name":81,"class":39},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":52,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":82},"100561159","increasing-family-engagement-in-critical-care-100561159","NCT06586528","Increasing Family Engagement in Critical Care","Increasing Family Engagement in Critical Care: The NGAGE Trial (The NGAGE Trial)","NGAGE","Inclusion Criteria:\n\n* Adult family members (age ≥ 18 years) of ICU patients\n* Expected ICU stay ≥ 48 hours\n* Able to participate in English or French\n\nExclusion Criteria:\n\n* Family members who do not wish to participate in care\n* Repeat admissions within the study period\n* Another family member has already participated in the study",{"count":51,"type":19},[54],"The primary aim of this trial is to evaluate if the NGAGE tool improves care engagement in family members of ICU patients. The secondary objectives are to assess if the NGAGE tool improves communication, care satisfaction, psychological symptoms, and quality of life in family members of ICU patients.\n\nThe NGAGE trial is a stepped wedge cluster randomized trial of 6 Canadian adult ICUs, involving 194 family members. A family member will be considered anyone with a biological, emotional, or legal relationship with the patient and whom the patient wishes to be involved in their care. There will be random and sequential crossover of clusters from control (phase 1) to intervention (phase 2) until all clusters are exposed. The intervention group will have access to the NGAGE tool, which has modules to Learn, Engage, and Report. \"Engage\" allows the family member to indicate their desired engagement activity, which is then transmitted to the treating healthcare team to provide the requested activity. \"Learn\" contains educational capsules about the ICU environment and information about care participation. \"Report\" allows the family member to provide real-time feedback to the healthcare team. The primary endpoint is the FAMily Engagement (FAME) score within 1 week of ICU discharge. Secondary endpoints are family-centered outcomes, including communication quality, satisfaction, and mental health (anxiety and depression) scores within 1 week of ICU discharge, and quality of life and mental health (anxiety, depression, and post-traumatic distress symptoms) at 6 months. The mean difference of the validated FAME score, a continuous variable, will be compared between groups.",[58,63,59,60,61],[66,58,67,68,69,70],{"date":178,"type":32},"2025-05-18",{"date":180,"type":32},"2025-03-26",{"date":182,"type":19},"2027-09",{"name":81,"class":39},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":194,"conditions":195,"keywords":199,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100567445","the-effect-of-parental-presence-on-the-childs-comfort-and-physiologic-parameters-in-picu-100567445","NCT06668285","The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU","Inclusion Criteria\n\n1. Being hospitalized in Behçet Uz Pediatric Intensive Care Unit\n2. Parent's volunteering to participate in the study Exclusion Criteria\n\n1\\. Any intervention by the child's parent that may affect the dependent variables (watching cartoons, listening to music, etc.)","0 Years","3 Years",{"count":193,"type":19},50,"The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study.\n\nThe population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day.\n\nPhysiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study.",[23,196,197,198],"Comfort","Vital Sign Evaluation","Parent",[200,201,202,203],"family centered care","parents presence","comfort","vital signs","2025-04-05",{"date":206,"type":32},"2025-04-09",{"date":208,"type":19},"2025-04-15",{"date":210,"type":19},"2025-07",{"name":212,"class":39},"Izmir Katip Celebi University",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":142,"sex":16,"minAge":220,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":82},"100461311","multidimensional-assessment-of-infant-parent-and-staff-outcomes-during-a-family-centered-care-enhancement-project-100461311","NCT05286983","Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project","Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project in a Tertiary Neonatal Intensive Care","Inclusion Criteria:\n\n* ≤32+0 weeks of gestational age (GA) and\u002For birthweight ≤1500g\n* biparental (or guardian) written informed consent\n\nExclusion Criteria:\n\n* severe congenital anomalies (e.g. cyanotic heart disease, severe lung hypoplasia, congenital diaphragmatic hernia)\n* decision not to provide full life support\n* decision for palliative care before study entry\n* parents with severe psychiatric disease","1 Minute","14 Days",{"count":223,"type":19},495,"This prospective single centre longitudinal cohort study enrols preterm infants ≤32+0 weeks of gestation and\u002For birthweight ≤1500g and their parents. Following a baseline period additional Family Centred Care elements are introduced as potentially better practices, these elements focus on four areas: the NICU (Neonatal Intensive Care Unit) environment, staff training, parental education and psychosocial support to the families. The effect of the implementation of additional Family Centred Care elements on infant, parent and staff outcomes are assessed. The parallel data collection enables to study the interrelation between these three important areas of research.",[23],"2025-03-25",{"date":228,"type":32},"2025-03-30",{"date":230,"type":32},"2020-10-01",{"date":232,"type":19},"2026-07-01",{"name":234,"class":39},"University of Giessen",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":142,"sex":16,"minAge":242,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":52,"phases":245,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":258,"locationsCount":40},"100564201","a-digital-game-on-promoting-family-well-being-100564201","NCT06626100","A Digital Game on Promoting Family Well-being","SMART Family-Link Project: A Digital Game on Promoting Family Well-being","Inclusion Criteria:\n\n* Chinese-speaking;\n* Parental consent for those under 18;\n* Able to understand and play the game;\n* Has a smartphone.\n\nExclusion Criteria:\n\n• Individuals who cannot meet the inclusion criteria.","10 Years",{"count":244,"type":19},800,[54],"Advances in information communication technologies (ICT) allow for ICT-assisted health promotion to become more common. Integrating ICT in health promotion has been suggested to offer many advantages compared to traditional approaches to promote family well-being. Research has also shown the positive effects of game-based approaches in enhancing health promotion interventions, especially with children. We will develop and conduct an online survey to assess the use of games and gamification for health promotion, as well as a family-based randomized controlled trial to promote healthy living.",[248,61],"Family Research",[250,251],"Gamification","Family well-being","2024-10-01",{"date":254,"type":32},"2024-10-03",{"date":256,"type":19},"2024-10-30",{"date":75,"type":19},{"name":259,"class":39},"The University of Hong Kong"]