[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621219":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":87,"studyPopulation":87,"armGroups":93,"interventions":110,"overallOfficials":121,"centralContacts":132,"locations":139,"responsibleParty":216,"collaborators":219,"id":232,"slug":233,"hasResults":234,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":234,"sex":240,"minAge":241,"maxAge":87,"enrollmentInfo":242,"targetDuration":87,"studyType":245,"phases":246,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":142,"whyStopped":87,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":268},{"fullName":5,"class":6},"University Hospital, Linkoeping","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":76},[9],{"measure":10,"description":11,"timeFrame":12},"Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 12 months)","The OsCare questionnaire is a self-administered assessment designed to evaluate patients' knowledge, motivation, and behavior related to osteoporosis management. It consists of items rated on an ordinal scale, where higher values indicate more favorable responses. The instrument yields both an overall score reflecting the general level of osteoporosis-related self-care, and subscale scores corresponding to the individual domains (knowledge, motivation, and behavior).","Baseline to follow up at 12 months.",[14,17,21,24,28,31,34,37,40,43,46,49,52,55,58,61,64,67,70,73],{"measure":15,"description":11,"timeFrame":16},"Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 3 months)","Baseline to follow-up at 3 months.",{"measure":18,"description":19,"timeFrame":20},"Health-related quality of life (HRQoL) - RAND-36","Assessed with RAND 36-Item Health Survey. The RAND-36 compromises 36 items covering 8 health-related domains.","Baseline to follow-up at 3 months and 12 months.",{"measure":22,"description":23,"timeFrame":20},"Health-related quality of life (HRQoL) - EQ-5D-5L","Assessed with the EuroQol 5 Dimensions (EQ5D-5L) and Visual Analogue Scale (VAS 0-100) where respondents rate their overall health.",{"measure":25,"description":26,"timeFrame":27},"Patient enablement instrument (PEI)","Measured with the Patient Enablement Instrument (PEI).","3 months and 12 months",{"measure":29,"description":30,"timeFrame":20},"Fear of falling","Assessed with Falls Efficacy Scale-International (FES-I). The FES-I is a 16-item questionnaire.",{"measure":32,"description":33,"timeFrame":20},"Illness perception","Assessed with the Brief-Illness Perception Questionnaire BIPQ which is an 8-item questionnaire.",{"measure":35,"description":36,"timeFrame":20},"Beliefs about the necessity of prescribed medication","Assessed using Beliefs about Medicines Questionnaire (BMQ).",{"measure":38,"description":39,"timeFrame":20},"Physical activity (self-reported)","Measured with questions from the Swedish Questionnaire about Lifestyle Habits.",{"measure":41,"description":42,"timeFrame":20},"Fall incidence (self-reported)","Self-reported numbers of fall during the last 3 and 12 months",{"measure":44,"description":45,"timeFrame":20},"Perceived balance (self-reported)","Self-rated perceived balance is assessed with Numeric Rating Scale (NRS 0-10).",{"measure":47,"description":48,"timeFrame":20},"Perceived pain (self-reported)","Self-reported pain is assessed both regarding intensity (Numeric Rating Scale \\[NRS\\] 0-10) and frequency.",{"measure":50,"description":51,"timeFrame":20},"Use of pain-relieving medication (self-reported)","Self-reported use of pain-relieving medication, including type and frequency.",{"measure":53,"description":54,"timeFrame":20},"Fracture risk score","Composite score based on results for balance (One-leg-standing test with eyes opened), leg muscle srength (Chair-Stand test- 30 sec), and patient-reported fall incidence during the last year.",{"measure":56,"description":57,"timeFrame":20},"Maximal walking speed","Walking speed assessed with patients walking 10 meters at a maximal walking speed.",{"measure":59,"description":60,"timeFrame":20},"Hand-strength","Assessed in sitting position with the Jamar. Values from both right and left side are assessed.",{"measure":62,"description":63,"timeFrame":20},"Chair-Stand test (30 sec)","The maximal number of sit to stand during 30 seconds.",{"measure":65,"description":66,"timeFrame":20},"Measure of hyperkyfosis","With patients in upright standing measuring distance between the C7 and the wall",{"measure":68,"description":69,"timeFrame":20},"Timed-up and go (TUG)","Patients were asked to stand up from sitting and walk 3 meters, turning around, walk back and sit again. Time was measured in seconds.",{"measure":71,"description":72,"timeFrame":20},"Static balance","Assessed with the One-leg-Standing test with eyes opened (OLST-EO) for both right and left legs and a maximum of 60 seconds.",{"measure":74,"description":75,"timeFrame":20},"Dynamic balance","Measured with the Four Square Step Test (FSST) as the time in seconds to perform a sequence that require the subject to step forward, backward, and sideway to the right and left.",[77,80],{"measure":78,"description":79,"timeFrame":20},"Accelerometer-based assessment of physical activity and sedentary behaviours","Measured with ActivPAL™ accelerometers in a subset of patients during 7 days",{"measure":81,"description":82,"timeFrame":83},"Adverse event","Adverse events will be monitored throughout the study period. Self-reported adverse events related to fracture, musculoskeletal injury, falls, increased uncertainty and worry, or other health-related complaints will be collected at follow-up assessments.","Baseline to follow-up at 3 months and 12 months",{"allocation":85,"interventionModel":86,"interventionModelDescription":87,"primaryPurpose":88,"observationalModel":87,"timePerspective":87,"maskingInfo":89},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":90,"maskingDescription":87,"whoMasked":91},"SINGLE",[92],"OUTCOMES_ASSESSOR",[94,100,105],{"label":95,"type":96,"description":97,"interventionNames":98},"Usual care (Control)","ACTIVE_COMPARATOR","General information on osteoporosis (open website)",[99],"Behavioral: General information on osteoporosis (open website)",{"label":101,"type":96,"description":102,"interventionNames":103},"Face-to-face patient education","Structured group-based theoretical education ('osteoporosis school')",[104],"Behavioral: Face-to-face patient education",{"label":106,"type":96,"description":107,"interventionNames":108},"Digital patient education","Internet-based patient education program",[109],"Behavioral: Digital patient education",[111,115,118],{"type":112,"name":106,"description":113,"armGroupLabels":114,"otherNames":87},"BEHAVIORAL","An internet-based program comprising nine modules will be available to participants for a duration of one year. The program addresses essential components of patient education in osteoporosis and includes a variety of learning formats such as text, images, videos, reflection exercises, knowledge-check questions, and checklists. The estimated total time required to complete the program is approximately 5.5 hours. Intervention adherence will be monitored. For the digital intervention, adherence will be assessed by number of modules accessed.",[106],{"type":112,"name":101,"description":116,"armGroupLabels":117,"otherNames":87},"Three theoretical sessions, each lasting two hours, will be conducted over a period of 3-5 weeks. The sessions adhere to a standardized curriculum addressing key aspects of osteoporosis management. Two sessions will be led by physiotherapists, and one session by either a physician or a nurse. Each group will include a maximum of 15 participants. Intervention adherence will be monitored. For the group-based intervention, attendance at scheduled sessions will be recorded.",[101],{"type":112,"name":97,"description":119,"armGroupLabels":120,"otherNames":87},"Participants receive general osteoporosis information provided by healthcare services (open website with general information on osteoporosis: https:\u002F\u002Fwww.1177.se\u002Fsjukdomar--besvar\u002Fskelett-leder-och-muskler\u002Fbenskorhet---osteoporos\u002F ).",[95],[122,126,129],{"name":123,"affiliation":124,"role":125},"Anna Spångeus, Ass Prof MD","Region Östergötland","STUDY_CHAIR",{"name":127,"affiliation":124,"role":128},"Johanna Wibault, PhD","PRINCIPAL_INVESTIGATOR",{"name":130,"affiliation":131,"role":128},"Gunnel Peterson, Assoc Prof","Sormland County Council, Sweden",[133,137],{"name":123,"role":134,"phone":135,"phoneExt":87,"email":136},"CONTACT","+46-10-1030000","anna.spangeus@liu.se",{"name":127,"role":134,"phone":135,"phoneExt":87,"email":138},"johanna.wibault@regionostergotland.se",[140,156,166,176,186,197,206],{"facility":141,"status":142,"city":143,"state":87,"zip":87,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":151,"contacts":152},"Region Gävleborg","RECRUITING","Gävle","Sweden","SE",{"type":147,"coordinates":148},"Point",[149,150],17.14174,60.67452,{"lat":150,"lon":149},[153],{"name":154,"role":134,"phone":135,"phoneExt":87,"email":155},"Research coordinator at Linköpings University Hospital","osteoporosforskning@regionostergotland.se",{"facility":157,"status":142,"city":158,"state":87,"zip":87,"country":144,"countryCode":145,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Region Jönköpings län","Jönköping",{"type":147,"coordinates":160},[161,162],14.15618,57.78145,{"lat":162,"lon":161},[165],{"name":154,"role":134,"phone":135,"phoneExt":87,"email":155},{"facility":167,"status":142,"city":168,"state":87,"zip":87,"country":144,"countryCode":145,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Region Kalmar","Kalmar",{"type":147,"coordinates":170},[171,172],16.36163,56.66157,{"lat":172,"lon":171},[175],{"name":154,"role":134,"phone":135,"phoneExt":87,"email":155},{"facility":177,"status":142,"city":178,"state":87,"zip":87,"country":144,"countryCode":145,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Region Sörmland","Katrineholm",{"type":147,"coordinates":180},[181,182],16.20721,58.99587,{"lat":182,"lon":181},[185],{"name":154,"role":134,"phone":135,"phoneExt":87,"email":155},{"facility":187,"status":188,"city":189,"state":87,"zip":87,"country":144,"countryCode":145,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Region Halland","NOT_YET_RECRUITING","Kungsbacka",{"type":147,"coordinates":191},[192,193],12.07612,57.48719,{"lat":193,"lon":192},[196],{"name":154,"role":134,"phone":135,"phoneExt":87,"email":155},{"facility":124,"status":142,"city":198,"state":87,"zip":87,"country":144,"countryCode":145,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Linköping",{"type":147,"coordinates":200},[201,202],15.62157,58.41086,{"lat":202,"lon":201},[205],{"name":154,"role":134,"phone":135,"phoneExt":87,"email":155},{"facility":207,"status":142,"city":208,"state":87,"zip":87,"country":144,"countryCode":145,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Region Örebro","Örebro",{"type":147,"coordinates":210},[211,212],15.2066,59.27412,{"lat":212,"lon":211},[215],{"name":154,"role":134,"phone":135,"phoneExt":87,"email":155},{"type":128,"investigatorFullName":217,"investigatorTitle":218,"investigatorAffiliation":5,"oldNameTitle":87,"oldOrganization":87},"Anna Spangeus","Senior Associated Professor, Senior Consultant",[220,223,225,227,228,230],{"name":221,"class":222},"Örebro County Council","OTHER_GOV",{"name":224,"class":6},"Region Kalmar County",{"name":226,"class":222},"County Council of Halland, Sweden",{"name":131,"class":6},{"name":229,"class":6},"County Council of Gavleborg",{"name":231,"class":222},"Region Jönköping County","100621219","patient-education-in-osteoporosis-rct-patos-100621219",false,"NCT07367776","Patient Education in Osteoporosis (RCT-PATOS)","Effects and Mechanisms of Patient Education in Osteoporosis: A Randomized Controlled Trial Comparing Digital Education, Face-to-Face Education, and General Patient Information (RCT-PATOS)","RCT-PATOS","Inclusion Criteria:\n\n* Women and men\n* Age \\> 50 years\n* Diagnosed with osteoporosis or osteopenia (either ICD-coded \\[M80x, M81x, or M859\\] or current\u002Fprevious pharmacological treatment for osteoporosis)\n* Basic computer literacy\n* Possession of BankID (Swedish electronic identification system used for secure authentication) and ability to log in to the 1177.se \"Support and Treatment platform\"\n\nExclusion Criteria:\n\n* Inability to understand written and spoken Swedish\n* Cognitive impairment preventing comprehension of the study protocol and provision of informed consent\n* Participation in structured patient education on osteoporosis within the past year","ALL","50 Years",{"count":243,"type":244},600,"ESTIMATED","INTERVENTIONAL",[247],"NA","The objective of this randomized clinical trial is to assess both the effectiveness and underlying mechanisms of patient education for individuals aged 50 years and older with osteoporosis.\n\nPrimary research question: What differences in outcomes can be observed among three different educational interventions with respect to osteoporosis-specific self-care, health related quality of life, fracture risk, illness perception, physical activity, physical function, fear of falling, and pain in patients diagnosed with osteoporosis?\n\nThe trial will include three study arms: 1) Control group: Participants receive standard osteoporosis information provided by healthcare services. 2) Face-to-face education: Three 2-hours sessions led by a physiotherapist (two sessions) and physician or nurse (one session) within a 2 months period. 3) Digital education: Internet-based program consisting of nine modules accessible to participants over a one-year period.\n\nParticipants will complete questionnaires and undergo physical assessments at baseline, and at 3 and 12 months follow up. Additionally, a subset of participants will undergo objective assessment of physical activity pattern and sedentary behaviours with an accelerometer at baseline and after 3 and 12 months.",[250],"Osteoporosis",[252,253,254,255,256,257,258],"osteoporosis","patient education","self-care","health related quality of life","HRQoL","internetbased","digital","2026-09-04",{"date":261,"type":262},"2026-09-08","ACTUAL",{"date":264,"type":262},"2026-01-27",{"date":266,"type":244},"2028-10-20",{"name":5,"class":6},7]