[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658149":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":34,"overallOfficials":13,"centralContacts":45,"locations":52,"responsibleParty":68,"collaborators":13,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":37,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":13,"enrollmentInfo":81,"targetDuration":13,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":54,"whyStopped":13,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"China Medical University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Time From Specimen Collection to Availability of Influenza Test Result","Time elapsed between collection of the respiratory specimen and availability of the influenza test result for clinical decision-making, compared between the ID NOW point-of-care testing strategy and the standard laboratory-based RT-PCR diagnostic pathway.","During the index influenza-like illness episode, from specimen collection to availability of the test result, up to 48 hours",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","SCREENING",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","Long-term care facilities (LTCFs) play an increasingly important role in healthcare systems as populations age. However, LTCFs are also settings with a high risk of respiratory infectious disease transmission. Influenza outbreaks in these facilities are of particular concern because residents often have advanced age, multiple chronic comorbidities, and age-related immune dysfunction, all of which may increase the risks of severe disease, hospitalization, and mortality. In addition to acute respiratory complications, influenza infection in this population may also be associated with subsequent cardiovascular events, metabolic deterioration, and prolonged functional decline.\n\nIn current clinical practice, influenza diagnosis in LTCFs commonly relies on reverse transcription polymerase chain reaction (RT-PCR) testing performed by external laboratories. The interval between specimen collection and reporting of results may be approximately 24 to 48 hours. This delay may affect the timing of clinical decision-making, including initiation of antiviral therapy and implementation of infection prevention and control measures. During the period when diagnostic results are unavailable, LTCFs may also need to implement precautionary isolation or cohorting measures for residents with suspected influenza-like illness, which may increase healthcare resource utilization and staff workload.\n\nThe Abbott ID NOW system is a rapid molecular diagnostic platform based on isothermal nucleic acid amplification technology (INAAT) and can provide molecular test results within approximately 15 minutes. The availability of rapid molecular testing at the point of care may shorten the time between clinical suspicion, diagnostic testing, and subsequent management decisions.\n\nThis study is designed as a prospective, cluster-randomized, open-label, two-arm, active-controlled study to evaluate the impact of two different influenza diagnostic strategies in residents of LTCFs in Taiwan: an ID NOW-based point-of-care testing strategy and the current standard diagnostic pathway. The study aims to determine whether the implementation of rapid point-of-care molecular testing can improve clinical outcomes and healthcare resource utilization compared with the standard diagnostic approach.\n\nThe study is planned to be conducted in 8 to 10 legally registered residential LTCFs, including nursing homes and other long-term care institutions, located in northern, central, southern, and eastern Taiwan. Participating facilities are required to have at least 40 approved beds, sufficient healthcare personnel to follow the study procedures, the ability to perform on-site specimen collection and infection-control measures, and an established system of regular physician visits. Institutional management approval is required before a facility enters the randomization process.\n\nSpecific participating rooms within the study facilities will be designated for study participation. Residents living in these participating rooms will be considered potential participants during the study period. Enrollment will be event-driven rather than based on routine screening of all residents. Nursing staff at participating LTCFs will monitor residents for acute clinical events suggestive of influenza-like illness. When a resident develops symptoms or signs that meet the study inclusion criteria, the responsible physician will perform a clinical assessment to determine whether the resident is potentially eligible and to exclude alternative diagnoses that clearly explain the clinical presentation. After eligibility assessment and informed consent, the resident will be formally enrolled in the study.\n\nEligible participants may include residents with acute onset of fever, decreased oxygen saturation, respiratory symptoms, or clinical suspicion of influenza. Specific eligibility criteria include acute illness with tympanic temperature of at least 38°C persisting for at least 24 hours; acute illness associated with decreased oxygen saturation or deterioration in oxygenation; influenza infection highly suspected by the treating physician; residents aged 65 years or older with relevant comorbidities who develop acute illness with tympanic temperature of at least 37.5°C persisting for at least 24 hours; or at least one respiratory symptom, such as cough, sore throat, or rhinorrhea, persisting for at least 24 hours.\n\nResidents will be excluded if an alternative definite diagnosis is identified at the initial assessment that adequately explains the influenza-like illness, including conditions such as bacterial pneumonia, non-respiratory infection, aspiration pneumonia, definite urinary tract infection, or exacerbation of heart failure without evidence of infection. Additional exclusion criteria include refusal to provide informed consent, expected survival of less than 48 hours, previous participation in the study within the preceding 14 days, and residence in a dedicated dementia care unit.\n\nIn the intervention group, eligible residents with suspected influenza-like illness will undergo point-of-care molecular testing using the Abbott ID NOW system. Nasal or nasopharyngeal swab specimens will be collected at the LTCF, and the test result will be available rapidly to support subsequent clinical and infection-control decisions. In the control group, residents will be managed according to the current standard diagnostic pathway, which relies on conventional laboratory-based RT-PCR testing and routine clinical management.\n\nThe study is open-label because the diagnostic strategy assigned to each group cannot be concealed from healthcare personnel. The study uses a parallel two-group design with active comparison between the ID NOW point-of-care testing strategy and the standard diagnostic pathway.\n\nA total of 1,080 participants are planned for enrollment. The minimum eligible age is 20 years, with no specified upper age limit. Each enrolled participant will be followed for 30 days after the qualifying influenza-like illness event.\n\nClinical and healthcare utilization data will be collected during the follow-up period to evaluate differences between the two diagnostic strategies. The study is intended to provide evidence on whether rapid point-of-care molecular testing can shorten the diagnostic process, support more timely clinical and infection-control decision-making, improve resident outcomes, and reduce unnecessary healthcare resource utilization and overall healthcare costs in LTCFs.",[22,28],{"label":23,"type":24,"description":25,"interventionNames":26},"ID NOW Point-of-Care Testing Strategy","EXPERIMENTAL","Participants in this arm will receive point-of-care molecular testing for suspected influenza using the Abbott ID NOW system at the participating long-term care facility. Nasal or nasopharyngeal swab specimens will be collected on site, and the rapid test result will be used to support subsequent clinical management and infection prevention and control decisions.",[27],"Device: Abbott ID NOW Point-of-Care Testing",{"label":29,"type":30,"description":31,"interventionNames":32},"Standard Diagnostic Pathway","ACTIVE_COMPARATOR","Participants in this arm will receive the current standard diagnostic pathway for suspected influenza, including laboratory-based reverse transcription polymerase chain reaction (RT-PCR) testing performed through the usual external laboratory process, together with routine clinical management and infection-control measures.",[33],"Diagnostic Test: Standard Laboratory-Based RT-PCR Diagnostic Pathway",[35,40],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":13},"DEVICE","Abbott ID NOW Point-of-Care Testing","Abbott ID NOW is a rapid molecular diagnostic platform based on isothermal nucleic acid amplification technology for the detection of influenza. Testing will be performed at the participating long-term care facility using nasal or nasopharyngeal swab specimens collected from eligible residents with suspected influenza-like illness. The system can provide molecular test results within approximately 15 minutes.",[23],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":13},"DIAGNOSTIC_TEST","Standard Laboratory-Based RT-PCR Diagnostic Pathway","Standard-of-care influenza testing using reverse transcription polymerase chain reaction (RT-PCR) performed through the usual external laboratory workflow. Test results are generally available within approximately 24 to 48 hours and are used together with routine clinical assessment to guide subsequent management and infection-control decisions.",[29],[46],{"name":47,"role":48,"phone":49,"phoneExt":50,"email":51},"Chia-Hui Tan, Ph.D","CONTACT","886-4-2205-3366","6321","elisetan@mail.cmu.edu.tw",[53],{"facility":5,"status":54,"city":55,"state":13,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Taichung","404","Taiwan","TW",{"type":60,"coordinates":61},"Point",[62,63],120.6839,24.1469,{"lat":63,"lon":62},[66],{"name":47,"role":48,"phone":67,"phoneExt":50,"email":51},"886-4-22053366",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Po-Ren Hsueh","Superintendent","100658149","abbott-id-now-point-of-care-testing-100658149",false,"NCT07846423","Evaluating the Clinical Outcomes of Abbott ID NOW Point-of-Care Testing for Respiratory Illnesses in Long-Term Care Facility Residents in Taiwan: Cluster-Randomized Controlled Trial","IDNOW2026","Inclusion Criteria:\n\n* Acute onset of illness with fever (tympanic temperature ≥38°C) persisting for at least 24 hours.\n* Acute onset of illness accompanied by decreased oxygen saturation (e.g., SpO₂ decreased to 94% or deterioration in oxygenation), or influenza infection highly suspected by the treating physician.\n* Residents aged 65 years or older with comorbidities (e.g., diabetes mellitus, dialysis, hypertension, heart disease, or use of immunosuppressive agents) who develop acute illness with fever (tympanic temperature ≥37.5°C) persisting for at least 24 hours.\n* At least one respiratory symptom, such as cough, sore throat, or rhinorrhea, persisting for at least 24 hours.\n\nExclusion Criteria:\n\n* A definite alternative diagnosis identified at the initial assessment that explains the influenza-like illness, such as bacterial pneumonia, non-respiratory infection, aspiration pneumonia following choking during feeding, definite urinary tract infection, or known exacerbation of heart failure without evidence of infection.\n* Refusal by the resident or the resident's legally authorized representative to provide informed consent for data collection.\n* Expected survival of less than 48 hours, as assessed by a physician.\n* Participation in this study within the previous 14 days, to avoid duplicate enrollment for the same illness episode.\n* Residence in a dedicated dementia care unit, because differences in disease characteristics, communication ability, and care practices may affect the internal validity of the study.","ALL","20 Years",{"count":82,"type":83},1080,"ESTIMATED","INTERVENTIONAL",[86],"NA","With the rapid aging of the global population, long-term care facilities (LTCFs) have become an increasingly important component of modern public health systems. However, these settings are also at high risk for outbreaks of respiratory infectious diseases. Influenza virus transmission within LTCFs has distinct epidemiological characteristics, including high transmissibility and high risks of severe illness and mortality. In Taiwan, with the accelerated aging of the population, LTCF residents commonly have multiple chronic comorbidities (multimorbidity) and age-related immune dysfunction (immunosenescence). Influenza infection in this population may not only lead to acute respiratory failure but may also contribute to a \"silent burden,\" including post-infection cardiovascular events, metabolic dysregulation, and long-term functional decline.\n\nUnder the current standard of care (SOC), influenza diagnosis relies on reverse transcription polymerase chain reaction (RT-PCR) testing performed by external laboratories, with a turnaround time (TAT) of approximately 24 to 48 hours. This time-to-result gap may delay clinical decision-making, potentially preventing timely initiation of antiviral treatment within the optimal 48-hour treatment window and leading facilities to adopt broad precautionary isolation measures, thereby increasing healthcare resource utilization and staffing burden.\n\nThe Abbott ID NOW system uses isothermal nucleic acid amplification technology (INAAT) and can provide molecular diagnostic results within approximately 15 minutes. Through a prospective cluster-randomized controlled design, this study aims to evaluate whether implementation of an ID NOW-based point-of-care testing (POCT) strategy can improve clinical outcomes among LTCF residents and reduce overall healthcare costs compared with the current standard diagnostic pathway.",[89,90],"Influenza","Influenza-like Illness",[92,93,94,95],"Point-of-Care Testing","Long-Term Care Facility","Cluster-Randomized Controlled Trial","Influenza-like illness","2026-09-23",{"date":98,"type":99},"2026-09-29","ACTUAL",{"date":101,"type":83},"2026-10-01",{"date":103,"type":83},"2027-12-31",{"name":5,"class":6},1]