[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patient-reported-outcome-measures-proms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patient-reported-outcome-measures-proms":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100633373","a-pragmatic-clinical-trial-of-the-we-beat-well-being-education-program-in-adolescent-congenital-heart-disease-we-beat-chd-study-100633373",false,"NCT07525843","A Pragmatic Clinical Trial of the WE BEAT Well-Being Education Program in Adolescent Congenital Heart Disease: WE BEAT CHD Study","PHN WBC","Inclusion Criteria:\n\n* Age 12-17 years old\n* CHD of moderate or severe complexity (Class II\u002FIII, 2018 AHA\u002FACC ACHD, Table 4)\n* English or Spanish language proficiency\n* Receives cardiology care at a PHN or PHN auxiliary site\n* Parent or guardian and participant willing to comply with protocol and provide written\u002Felectronic informed consent and assent\n\nExclusion Criteria:\n\n* CHD of mild or simple complexity (Class I, 2018 AHA\u002FACC ACHD, Table 4)\n* Prior heart transplant to treat CHD\n* Heart disease that is not classified as structural CHD (e.g., connective tissue disease, genetic cardiomyopathy, or acquired heart disease)\n* Cognitive or developmental conditions that limit program participation and\u002For ability to complete self-reported measures as determined by a primary cardiology clinician\n* Suicidality, homicidality, or psychosis in the past 12 months as per medical chart review, clinician report, or eligibility screening\n* Medically unable to participate (e.g., intubated, unable to respond verbally, active delirium)","ALL","12 Years","17 Years",{"count":20,"type":21},390,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this pragmatic clinical trial is to learn if the WE BEAT program, a 5-week group-based online wellbeing and skill-building program, can help teens with congenital heart disease (CHD) improve their ability to handle stress. The main question it aims to answer is if participants who receive the WE BEAT program become more resilient (the ability to bounce back from from tough times or recover from something difficult) and have better quality of life compared to participants who receive usual care. The study also aims to learn if there are connections between participant-reported psychosocial data (such as resilience, feelings about one's life and one's physical, mental, and social wellbeing) and clinical outcomes.\n\nEligible participants who are 12-17-year-old will be in the study for about 6 months and be randomized to receive either the WE BEAT program or usual care. Following completion of the primary WE BEAT intervention at Week 5, intervention arm participants will be randomized to a single-session booster session (occurring at Week 18) vs no booster session. The booster session will be provided in a similar format to the WE BEAT program. A review of all modules\u002Fskills introduced in the program will be provided.\n\nAll participants will complete 4 sets of online surveys and give 3 hair\u002Fsaliva samples at different timepoints. Some participants may volunteer to give optional blood and urine samples.",[27,28,29,30,31,32],"Patient-Reported Outcome Measures (PROMs)","Pragmatic Trial","Adolescent Congenital Heart Disease","Resiliency-building Intervention","Resilience, Psychological","Telemedicine-Based Education",[34,35,36,37,38],"WE BEAT","Well-Being Education Program","Adolescent CHD","Pragmatic Clinical Trial","Telemedicine","RECRUITING","2026-06-18",{"date":42,"type":43},"2026-06-22","ACTUAL",{"date":45,"type":43},"2026-04-20",{"date":47,"type":21},"2029-06",{"name":49,"class":50},"Carelon Research","OTHER",14,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100597180","digital-aftercare-for-wrist-and-clavicle-fractures-100597180","NCT07055139","Digital Aftercare for Wrist and Clavicle Fractures","Comparison of Digital Versus Traditional Aftercare for Uncomplicated Distal Radius and Clavicle Fractures","DA-DRAC","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Surgically treated, uncomplicated distal radius or clavicle fracture\n* Use of a smartphone (iOS or Android)\n* Ability to understand German and complete study-related questionnaires\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Polytrauma or additional injuries to the same upper extremity\n* No access to or inability to use a smartphone\n* Cognitive, psychiatric, or language barriers impairing participation\n* Pregnancy\n* Inability or unwillingness to comply with the study protocol","18 Years","65 Years",{"count":63,"type":21},84,[24],"This prospective, two-arm, open-label clinical trial compares digital aftercare with traditional follow-up in adult patients after surgical treatment of uncomplicated distal radius or clavicle fractures. The primary objective is to assess functional recovery at three months, using the Patient-Rated Wrist Evaluation (PRWE) for wrist fractures and the QuickDASH for clavicle fractures. Secondary outcomes include range of motion, patient satisfaction, quality of life, complication rates, healthcare costs, and work disability. In the digital aftercare group, program adherence and user experience will also be evaluated through app usage data and a structured questionnaire. The study aims to determine whether digital aftercare is a clinically and economically equivalent alternative to standard in-person care.",[67,68,69,27,70],"Distal Radius Fracture","Clavicle Fracture","Postoperative Care","Upper Extremity Fractures",[72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,69],"distal radius fracture","clavicle fracture","digital aftercare","app-based aftercare","App-Based Rehabilitation","Wrist Fracture","Fracture Recovery","Functional Outcome","QuickDASH","PRWE","eHealth","Patient Satisfaction","Quality of Life","EQ-5D","Complication Rate","NOT_YET_RECRUITING","2025-06-27",{"date":90,"type":43},"2025-07-08",{"date":92,"type":21},"2025-09-01",{"date":94,"type":21},"2027-03-31",{"name":96,"class":50},"Luzerner Kantonsspital",1,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":109,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":118,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":97},"100583234","validation-of-the-eq-5d-y-3l-and-eq-5d-y-5l-for-paediatric-patients-in-china-100583234","NCT06873672","Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China","Using EQ-5D-Y to Measure the Health of Patients for Multiple Paediatric Health Conditions: a Project to Validate the Self-complete, Interviewer-administered and Proxy Administered Versions of EQ-5D-Y-3L and EQ-5D-Y-5L in China","Inclusion Criteria:\n\n* Children (Patients)\n\n  1. Age: 5-16 years old.\n  2. Diagnosis: Clinically confirmed diagnosis of one of the following conditions:\n\n     Pneumonia (hospitalized due to community-acquired pneumonia); Central Nervous System (CNS) Solid Tumours (receiving active treatment or in post-treatment follow-up); Immune Thrombocytopenic Purpura (ITP) (diagnosed with acute or chronic ITP).\n  3. Health Status: Cognitively and physically capable of completing HRQoL assessments (for self-complete versions).\n  4. Language Proficiency: Able to understand and communicate in Mandarin Chinese.\n  5. Consent: Written informed consent obtained from the primary caregiver and verbal or written assent from the child (if age-appropriate).\n* Caregivers (Parents\u002FFamily Caregivers)\n\n  1. Primary Caregiver: Must be a parent or a long-term family caregiver (e.g., grandparent, older sibling, aunt, or uncle).\n  2. Involvement: Directly responsible for the daily care and medical decision-making of the child.\n  3. Language Proficiency: Able to understand and complete both the self-complete and proxy-reported HRQoL assessments in Mandarin Chinese.\n  4. Consent: Willing to provide informed consent for participation.\n\nExclusion Criteria:\n\n* Children (Patients)\n\n  1. Severe Cognitive or Developmental Impairment: Diagnosed with intellectual disability, autism spectrum disorder, or any neurological condition that prevents understanding and completing HRQoL assessments.\n  2. Severe Physical Disability:\n\n     Conditions that make it impossible to respond to surveys (e.g., advanced neuromuscular disease, severe paralysis).\n  3. Comorbidities: Presence of another major chronic illness that could significantly affect HRQoL measurement (e.g., severe congenital heart disease, uncontrolled epilepsy).\n  4. Recent Participation in Similar Studies:\n\n     If the child has participated in another HRQoL validation study within the past 6 months.\n  5. Inability to Complete Study Follow-Up: Expected to be transferred to another hospital or relocated during follow-up.\n* Caregivers (Parents\u002FFamily Caregivers)\n\n  1. Not the Primary Caregiver:\n  2. Individuals who do not have daily caregiving responsibilities for the child.\n\n     Cognitive Impairment or Severe Health Conditions:\n  3. Caregivers with severe mental illness, dementia, or a medical condition that affects their ability to complete surveys.\n  4. Language Barrier: Unable to understand and complete HRQoL assessments in Mandarin Chinese.\n  5. Refusal to Participate: Caregivers who decline to provide informed consent.","5 Years","16 Years",{"count":108,"type":21},360,"2 Weeks","OBSERVATIONAL","The goal of this observational study is to validate the EQ-5D-Y-3L and EQ-5D-Y-5L in measuring health-related quality of life (HRQoL) for paediatric patients with different health conditions in China. The main research questions focus on comparing the psychometric performance of EQ-5D-Y-3L and EQ-5D-Y-5L, evaluating the differences between self-complete (SC), interviewer-administered (IA), and proxy-administered (Proxy) versions, and assessing their validity against other HRQoL measures like PedsQL. The study will recruit 360 inpatient-caregiver dyads from three disease groups, i.e., pneumonia, paediatric central nervous system (CNS) solid tumours, and immune thrombocytopenic purpura (ITP), using cross-sectional and longitudinal surveys. Baseline assessments will be conducted at hospital admission, with follow-up at hospital discharge (within 14 days). A qualitative component will explore acceptability and interpretation of EQ-5D-Y. The findings will contribute to the methodological development of EQ-5D-Y, with potential implications for HRQoL measurement and economic evaluations in paediatric healthcare.",[113,27,114,115,116,117],"Quality of Life (QOL)","Pneumonia Childhood","Neuroblastoma (NB)","Wilms Tumour","Immune Thrombocytopenic Purpura ( ITP )",[119,120,121,122,123,124,125],"Quality of life","children","psychometric measurements","Paediatric pneumonia","Paediatric central nervous system solid tumour","paediatric immune thrombocytopenic purpura","spillover effect","2025-03-07",{"date":128,"type":43},"2025-03-13",{"date":130,"type":21},"2025-04-01",{"date":132,"type":21},"2027-12-31",{"name":134,"class":50},"RenJi Hospital"]