[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638098":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":52,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":80,"overallStatus":91,"whyStopped":18,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PIRe Stepped-Care Intervention","EXPERIMENTAL","Participants receive the PIRe intervention delivered within a stepped-care model targeting primary relatives of patients with acquired brain injury (ABI) or malignant brain tumor (MBT). All receive usual care (information and initial screening using Zarit-4). Based on screening and clinical assessment, support is escalated: Step 2 includes a structured PIRe conversation and needs assessment; Step 3 involves extended support and cross-sectoral coordination; Step 4 provides specialized interventions (e.g., neuropsychological support). The model enables tailored, progressive support according to caregiver burden.",[13],"Other: Supportive Care",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Participants receive standard care corresponding to Step 1 of the stepped-care model, including general information and no structured PIRe intervention or systematic escalation of support.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Supportive Care","The intervention uses a stepped-care model to support relatives based on their level of burden and support needs. All participants receive basic support, and additional support is offered step-by-step when needed.\n\nStep 1 - Usual Care and Screening All relatives receive usual care and basic information. Caregiver burden is screened using the 4-item Zarit Burden Interview (ZBI-4).\n\nStep 2 - Structured Support Relatives who screen positive on the ZBI-4 are offered a structured PIRe conversation with a nurse. The conversation focuses on the relative's role, needs, and wishes for involvement, as well as providing better overview of the care pathway.\n\nStep 3 - Extended Support Relatives with increased burden, based on ZBI-4 results and clinical assessment, receive extended and more targeted support, including follow-up conversations and improved coordination between hospital and community services.\n\nStep 4 - Specialized Support Relatives with high burden or complex needs receive specialized sup",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Rikke Guldager, PhD","CONTACT","0045 51199727","rikke.guldager.01@regionh.dk",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Ingrid Poulsen, Professor","004541277383","ingrid.poulsen@regionh.dk",[35],{"facility":36,"status":18,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Rigshospitalet","Copenhagen","Ø","2100","Denmark","DK",{"type":43,"coordinates":44},"Point",[45,46],12.56553,55.67594,{"lat":46,"lon":45},[49,51],{"name":50,"role":27,"phone":28,"phoneExt":18,"email":29},"Rikke Guldager Guldager, PhD",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Rikke Guldager","RN, MScN, PhD Head of Nursing Research","100638098","pire-20-a-stepped-care-model-for-involving-relatives-across-sectors-100638098",false,"NCT07590726","PIRe 2.0: A Stepped-Care Model for Involving Relatives Across Sectors","PIRe","Inclusion Criteria\n\n* Primary relative of an adult diagnosed with acquired brain injury (ABI) or malignant brain tumor (MBT), admitted to a participating hospital department.\n* Formally identified as the primary relative by the patient.\n* Aged ≥18 years.\n* Ability to read, understand, and complete questionnaires in Danish.\n\nExclusion Criteria\n\n* Insufficient proficiency in Danish to complete questionnaires and participate in structured conversations.\n* Concurrent participation in another interventional study with a similar aim that may interfere with the present study.","ALL","18 Years",{"count":66,"type":67},160,"ESTIMATED","INTERVENTIONAL",[70],"NA","Serious brain diseases and injuries affect not only the person who becomes ill or injured, but also their family. Relatives of people with acquired brain injury (ABI) or malignant brain tumor (MBT) often take on a major role in daily care, decision-making, and coordination across healthcare services. This role can include managing information, supporting rehabilitation, and acting as a link between hospital care and community rehabilitation. Many relatives report high levels of stress, uncertainty, and emotional burden, especially during transitions between care settings.\n\nDespite recommendations for greater involvement of relatives, support for this group is often uneven and poorly coordinated across healthcare sectors. Relatives frequently experience lack of overview, limited guidance, and unclear expectations regarding their role. These challenges may increase caregiver burden and negatively affect both relatives' well-being and the continuity of care.\n\nThe PIRe 2.0 study aims to further test, and implement a structured intervention to support systematic involvement of relatives of people with ABI or MBT across hospital and community rehabilitation services. The intervention is designed as a \"caregiver compass\" that helps relatives understand their role, clarify their needs and wishes for involvement, and gain better overview of the care pathway.\n\nPIRe 2.0 is delivered through a stepped-care model, which allows the level of support to be adjusted over time based on each relative's level of burden and support needs. All relatives receive basic information and screening for caregiver burden using the 4-item Zarit Burden Interview (ZBI-4). Relatives who show signs of increased burden are offered additional support in steps, ranging from structured conversations with nurses to extended cross-sector coordination and specialized support for relatives with high or complex needs. Decisions about stepping up or down are based on both screening results and clinical assessment to ensure flexibility and person-centered care.\n\nThe study includes two groups of relatives: an intervention group receiving support through the PIRe stepped-care model, and a control group receiving usual care only. A total of 160 relatives will participate. Data are collected at baseline, at transitions between hospital and community care, and three to six months after the intervention.\n\nThe primary outcome is change in caregiver burden, measured with the Caregiver Burden Scale (CBS). Secondary outcomes include relatives' roles and responsibilities, perceived support and involvement in care, and mental well-being, assessed using validated patient-reported outcome measures.\n\nIn addition to evaluating the effect of the intervention, the study examines how the PIRe model can be implemented and sustained in everyday practice across healthcare sectors. The results are expected to show whether a structured, stepped-care approach can reduce caregiver burden, improve coordination between hospital and community services, and support more coherent and secure care pathways for people with ABI or malignant brain tumor and their relatives.",[73,74,75,76,77,78,79],"Brain Injuries, Acute","Brain Tumor Adult","Brain (Nervous System) Cancers","Traumatic Brain Injuries","Glioblastom WHO Grade 4","Glioblastoma (GBM)","Stroke",[81,82,83,84,85,86,87,88,89,90],"Acquired brain injury","Malignant brain tumor","Relatives","Caregiver Burden","Involvement","Communication","Care transitions","Rehabilitation","Implementation","Stepped-care","NOT_YET_RECRUITING","2026-05-15",{"date":94,"type":95},"2026-05-19","ACTUAL",{"date":97,"type":67},"2026-10-01",{"date":99,"type":67},"2029-09-30",{"name":5,"class":6},1]