[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652394":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":33,"responsibleParty":91,"collaborators":93,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":19,"enrollmentInfo":111,"targetDuration":19,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":129,"whyStopped":19,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Sociedade Portuguesa de Reumatologia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"iPROLEPSIS Digital Health Ecossystem","EXPERIMENTAL","Participants with psoriatic arthritis will undergo a 12-month study period consisting of a 1-month baseline monitoring phase followed by an 11-month intervention phase. During the intervention period, participants will receive the iPROLEPSIS digital health programme , integrated with a wearable smartwatch and wireless earbuds. Healthcare professionals involved in participant follow up will use a dedicated clinical dashboard.",[13],"Behavioral: iPROLEPSIS Digital Health Ecossystem",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","The iPROLEPSIS Digital Health Programme is a multimodal digital health intervention designed to support self-management, healthy lifestyle behaviours, and remote clinical follow-up in adults with psoriatic arthritis. Participants will use the miPROLEPSIS mobile application for symptom monitoring, passive and active data collection, and personalised lifestyle recommendations; biAURA for sleep and stress management; iPROLEPSIS Games to promote physical and emotional well-being; and the miPROLEPSIS Joint Landmarker application for video-based functional assessment. The ecossystem also integrates a smartwatch and wireless earbuds.\n\nHealthcare professionals will use a dedicated clinical dashboard to monitor participant data and support clinical management throughout the intervention period.",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Ana Maria Rodrigues, MD, PhD","NOVA Medical School","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+351 965555061","ana.m.rodrigues@nms.ul.pt",{"name":31,"role":27,"phone":19,"phoneExt":19,"email":32},"Cátia Gonçalves, PhD","catia.goncalves@nms.unl.pt",[34,50,65,78],{"facility":35,"status":19,"city":36,"state":19,"zip":19,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Hipokrateion Hospital Thessaloniki","Thessaloniki","Greece","GR",{"type":40,"coordinates":41},"Point",[42,43],22.93493,40.64072,{"lat":43,"lon":42},[46],{"name":47,"role":27,"phone":48,"phoneExt":19,"email":49},"Ioanna Katsigianni, MD","+30 231 089 2000","katsigianniioan@gmail.com",{"facility":51,"status":19,"city":52,"state":19,"zip":19,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Unidade Local de Saúde de Aveiro, Serviço de Reumatologia, Hospital Infante Dom Pedro","Aveiro","Portugal","PT",{"type":40,"coordinates":56},[57,58],-8.64643,40.64575,{"lat":58,"lon":57},[61],{"name":62,"role":27,"phone":63,"phoneExt":19,"email":64},"Anabela Barcelos, MD, PhD","+351 966894176","barcelos.anabela@gmail.com",{"facility":66,"status":19,"city":67,"state":19,"zip":19,"country":53,"countryCode":54,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Unidade Local de Saúde de São José, Serviço de Reumatologia, Hospital Santo António dos Capuchos","Lisbon",{"type":40,"coordinates":69},[70,71],-9.1498,38.72509,{"lat":71,"lon":70},[74],{"name":75,"role":27,"phone":76,"phoneExt":19,"email":77},"Ana Teresa Melo, MD","+351 918613549","anateresamelo1992@gmail.com",{"facility":79,"status":19,"city":80,"state":19,"zip":19,"country":53,"countryCode":54,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Unidade Local de Saúde de São João, Serviço de Reumatologia, Hospital São João","Porto",{"type":40,"coordinates":82},[83,84],-8.61097,41.1485,{"lat":84,"lon":83},[87],{"name":88,"role":27,"phone":89,"phoneExt":19,"email":90},"Alexandra Bernardo, MD","+351 938507343","alexbernardo@sapo.pt",{"type":92,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[94,96,98,100],{"name":95,"class":6},"Erasmus Medical Center",{"name":97,"class":6},"University of Oxford",{"name":99,"class":6},"Aristotle University Of Thessaloniki",{"name":23,"class":6},"100652394","prevention-of-psoriatic-arthritis-inflammation-through-digital-care-a-feasibility-mixed-methods-study-100652394",false,"NCT07772544","Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study","iPROLEPSIS-PPIDC: Prevention of Psoriatic Arthritis Inflammation Through Digital Care: A Feasibility Mixed-Methods Study","PPIDC","Inclusion Criteria (Patients):\n\n* Willing and able to provide informed consent\n* Female or male, aged 18 years or older at the time of enrolment\n* Diagnosed with psoriatic arthritis\n* Had a rheumatology appointment in the past 12 months\n* Owns a smartphone (Android) compatible with the study apps\n* Willing to use the study smartwatch (Garmin Vivoactive 5) for the 12-month follow-up period\n* Proficient in the local language\n\nInclusion Criteria (Healthcare Professionals):\n\n* Willing and able to provide informed consent\n* Involved in the clinical follow-up of PsA patients enrolled in the study\n\nExclusion Criteria (Patients):\n\n* Illiteracy or inability to comply with the study protocol (e.g., due to hearing or visual impairments or significant cognitive impairment)\n* Lack of access to the necessary technology to participate in the study (e.g., smartphone or stable internet connection)","ALL","18 Years",{"count":112,"type":113},72,"ESTIMATED","INTERVENTIONAL",[116],"NA","This is an international, multicentre, feasibility mixed-methods, single-arm study evaluating the implementation of the iPROLEPSIS digital health promotion programme for adults with psoriatic arthritis (PsA) in real-world clinical practice.\n\nThe study will enrol 72 adults with PsA (18 participants per country) across Portugal, the Netherlands, Greece, and the United Kingdom. Participants will be followed for 12 months, including a 1-month baseline monitoring period without intervention, followed by an 11-month intervention period during which participants will use the iPROLEPSIS digital health ecosystem. The iPROLEPSIS ecosystem integrates multiple digital health tools designed to support lifestyle management, self-monitoring, and patient engagement in PsA care. Participants will use the miPROLEPSIS app for active and passive data collection and personalised lifestyle recommendations related to diet and physical activity; biAURA for sleep and stress management using binaural beats; iPROLEPSIS Games to promote physical and emotional well-beingthrough serious games; and the miPROLEPSIS Joint Landmarker app for video-based functional assessments. The ecosystem will also integrate data from a Garmin vívoactive 5 smartwatch and wireless earbuds. Healthcare professionals involved in participant follow-up will access a dedicated clinical dashboard to support monitoring and clinical management. The primary objective of this feasibility study is to evaluate the usability of the iPROLEPSIS digital health ecosystem among patients with PsA and healthcare professionals using the System Usability Scale (SUS) and the eHealth UsaBility Benchmarking Instrument (HUBBI). Secondary objectives include assessing participant retention, acceptability of study participation, engagement with the digital health tools, adherence to study procedures, and identifying barriers and facilitators influencing the implementation of the digital health programme in routine clinical practice.The study will also generate preliminary evidence regarding potential changes in clinical and patient-reported outcomes associated with the use of the iPROLEPSIS ecosystem and include a preliminary budget impact analysis to inform the design of a future larger-scale clinical trial.",[119],"Psoriatic Arthritis (PsA)",[121,122,123,124,125,126,127,128],"Psoriatic Arthritis","Digital Health","Feasibility Study","Usability","Disease Self-Management","Digital Biomarkers","Remote Monitoring","eHealth","NOT_YET_RECRUITING","2026-08-13",{"date":132,"type":133},"2026-08-19","ACTUAL",{"date":135,"type":113},"2026-08",{"date":137,"type":113},"2027-12",{"name":5,"class":6},4]