[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518605":3},{"organization":4,"outcomesModule":7,"designInfo":95,"detailedDescription":109,"studyPopulation":100,"armGroups":110,"interventions":121,"overallOfficials":126,"centralContacts":131,"locations":138,"responsibleParty":152,"collaborators":155,"id":158,"slug":100,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":100,"enrollmentInfo":167,"targetDuration":100,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":141,"whyStopped":100,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"University Hospital, Akershus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Inappropriate Z-hypnotics use","Proportion of patients with prolonged use of Z-hypnotics","6 weeks",[14,17,20,22,25,26,29,31,32],{"measure":15,"description":16,"timeFrame":12},"Pain visual analogue scale (VAS)","VAS assessment of experienced pain (1-100 mm, no pain (0), worst possible pain (100))",{"measure":18,"description":19,"timeFrame":12},"Cognitive function","Cognistat test total score (0-84, 84 best)",{"measure":18,"description":19,"timeFrame":21},"6 months",{"measure":23,"description":24,"timeFrame":12},"Experience of sleep","Global Sleep Assessment Questionnaire score (GSAQ) (11 items, Never, sometimes, usually, always. Item responses were converted to a common 0-100 scale, with a higher score indicating greater likelihood for presence of the disorder. .)",{"measure":23,"description":24,"timeFrame":21},{"measure":27,"description":28,"timeFrame":12},"Sleep efficiency (random subpopulation)","Actigraphy assessed before and after intervention",{"measure":30,"description":11,"timeFrame":12},"Change compared to baseline of Z-hypnotics use",{"measure":30,"description":11,"timeFrame":21},{"measure":10,"description":11,"timeFrame":33},"baseline",[35,38,41,44,45,48,51,54,57,59,62,66,70,72,75,76,80,83,84,85,86,87,88,89,91,93,94],{"measure":36,"description":37,"timeFrame":21},"Quality of life measure, index","Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation), 0-1 with 1 representing perfect health",{"measure":39,"description":40,"timeFrame":21},"Quality of life measure, VAS","Euro QoL, five dimension, 5 level version (EQ-5D VAS), 0-100 with 100 representing best health",{"measure":42,"description":43,"timeFrame":12},"Dependence score","Severity of dependence score (SDS), 0-15, 15 highest severity",{"measure":42,"description":43,"timeFrame":21},{"measure":46,"description":47,"timeFrame":12},"MoCa score","Telefon - Montreal Cognitive Assessment (T-MoCA) for remote assessments. (0-22 points, normal cognition ≥ 18 \u002F 22)",{"measure":49,"description":50,"timeFrame":12},"Self assessed cognitive function","Norwegian cognitive function instrument (KFI) (0-13 points yes=1 point, maybe=0,5 point, no=0 point)",{"measure":52,"description":53,"timeFrame":12},"Verbal fluency","FAS score (60 seconds timecap, using a cut-off score of 14 points indicating executive function deficits)",{"measure":55,"description":56,"timeFrame":12},"Multimorbidity","Cumulative Illness Rating Scale-Geriatric (CIRS-G) 0-56, 56 worst",{"measure":55,"description":56,"timeFrame":58},"12 months",{"measure":60,"description":61,"timeFrame":12},"Polypharmacy","Number of regularly used medications",{"measure":63,"description":64,"timeFrame":65},"Readiness to change behaviour","Readiness to change behavior visual analogue scale scale, 0-100, 100 most ready","Baseline",{"measure":67,"description":68,"timeFrame":69},"Prevalence of inappropriate medication use in screened population","Patient self report in screening questionnaire","At screening before baseline",{"measure":71,"description":68,"timeFrame":69},"Prevalence self-reported sleep difficulties",{"measure":73,"description":74,"timeFrame":12},"Anxiety and depression symptoms","Hospital anxiety and depression scale (HADS), 0-42, 42 worst",{"measure":73,"description":74,"timeFrame":21},{"measure":77,"description":78,"timeFrame":79},"Mortality","Based on automatic registration in electronic patient journal","12 months, 24 months",{"measure":81,"description":82,"timeFrame":12},"Cognitive function, subdimensions","Cognistat test, subdimensions score, higher score is better cognitive function",{"measure":81,"description":82,"timeFrame":21},{"measure":10,"description":11,"timeFrame":21},{"measure":15,"description":16,"timeFrame":58},{"measure":18,"description":19,"timeFrame":58},{"measure":10,"description":11,"timeFrame":58},{"measure":30,"description":11,"timeFrame":58},{"measure":36,"description":90,"timeFrame":58},"Euro QoL, five dimension, 5 level version (EQ-5D-5L index, Norwegian population norms valuation)",{"measure":39,"description":92,"timeFrame":58},"Euro QoL, 0 (worse) - 100(best)score (EQ-5D VAS)",{"measure":23,"description":24,"timeFrame":58},{"measure":15,"description":16,"timeFrame":21},{"allocation":96,"interventionModel":97,"interventionModelDescription":98,"primaryPurpose":99,"observationalModel":100,"timePerspective":100,"maskingInfo":101},"RANDOMIZED","PARALLEL","Parallel masked and controlled first part intervention vs Business as usual with follow-up after 6 months by masked assessors. Subsequently open single cross-over of business as usual patients to also receive the same intervention.","HEALTH_SERVICES_RESEARCH",null,{"masking":102,"maskingDescription":103,"whoMasked":104},"QUADRUPLE","GPs will be cluster randomized based on GP to two sequential teaching programs to learn the Brief Intervention procedure. The patients of those who have the course first will constitute the intervention arm while patients of GPs who are in the second course will constitute parallel business as usual controls in the masked part of the study. When the second group of GPs have their course, open cross-over will be possible.",[105,106,107,108],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Two armed study with controlled masked first part over 6 months. Active arm is with Brief Intervention for inappropriate use of Z-hypnotics among elderly with intervention delivered by trained GPs. Control arm is for patients handled by their (non-trained) GPs with business as usual (BAU). Main outcome is 6 weeks after intervention with additional data collection points after 6 months (blinded) and long-term follow-up to 12 months (open). After 6 months there will be an open single crossover as BAU GPs will then also receive training in the Brief Intervention method.\n\nBaseline assessments are limited to self reports and automatic sleep assessment with actigraphy to avoid assessment effects. Follow-up at main outcome time point is in person, some outcomes are also by telephone assessment and compared to baseline prior to intervention (e g Actigraphy assessment.",[111,117],{"label":112,"type":113,"description":114,"interventionNames":115},"BI (Brief Intervention)","ACTIVE_COMPARATOR","Patients whose GPs have been taught the behavioral BI intervention aiming to reduce prolonged use of Z-hypnotics.",[116],"Behavioral: BI (Brief Intervention)",{"label":118,"type":119,"description":120,"interventionNames":100},"BAU (Business as usual)","NO_INTERVENTION","Patients whose GPs have not yet been taught the BI intervention. Patients only assessed in parallel with BI group by masked assessors using same instruments as for active comparator.\n\nThis group also constitutes an open cross-over group to active intervention once the masked 6 months phase is completed.",[122],{"type":123,"name":112,"description":124,"armGroupLabels":125,"otherNames":100},"BEHAVIORAL","Short structured individual behavioral intervention to reduce inappropriate usage of Z-hypnotics",[112],[127],{"name":128,"affiliation":129,"role":130},"Christofer Lundqvist, MD, PhD","Akershus University Hospital and University of Oslo","STUDY_CHAIR",[132],{"name":133,"role":134,"phone":135,"phoneExt":136,"email":137},"Tahreem G Siddiqui, PhD","CONTACT","90600984","+47","tahs@ahus.no",[139],{"facility":140,"status":141,"city":142,"state":100,"zip":100,"country":143,"countryCode":144,"cosmosGeoPoint":100,"geoPoint":100,"contacts":145},"Akershus University Hospital","RECRUITING","Lørenskog","Norway","NO",[146,148,150],{"name":147,"role":134,"phone":100,"phoneExt":100,"email":100},"C Lundqvist, MD, PhD",{"name":128,"role":149,"phone":100,"phoneExt":100,"email":100},"PRINCIPAL_INVESTIGATOR",{"name":133,"role":151,"phone":100,"phoneExt":100,"email":100},"SUB_INVESTIGATOR",{"type":149,"investigatorFullName":153,"investigatorTitle":154,"investigatorAffiliation":5,"oldNameTitle":100,"oldOrganization":100},"Christofer Lundqvist","Professor",[156],{"name":157,"class":6},"University of Oslo","100518605",false,"NCT06032715","Brief Intervention for Sleep Medication Misuse Among Elderly","Brief Intervention for Reducing Prolonged Use of Sleep Medication Among Elderly","BI-sleep","Inclusion Criteria:\n\n* Self-reported use of Z-hypnotics \\> 4 days per week and \\> 4 weeks\n\nExclusion Criteria:\n\n* diagnosis of dementia,\n* diagnosis of psychosis,\n* diagnosis of major depression,\n* diagnosis of delirium,\n* unable to give informed consent,\n* insufficient Norwegian language capacity to complete tests","ALL","60 Years",{"count":168,"type":169},120,"ESTIMATED","INTERVENTIONAL",[172],"NA","Randomized controlled trial to evaluate effectiveness of behavioral Brief Intervention administered by General practitioners (GPs) versus business as usual on use of Z-hypnotics by elderly patients in primary care.",[175],"Harmful Use of Hypnotic",[177,178,179,180,181,182,183,184,185],"Z-hypnotics","insomnia","sleep","side effects","cognitive function","pain","behavioral intervention","dependence","quality of life","2024-11-13",{"date":188,"type":189},"2024-11-15","ACTUAL",{"date":191,"type":189},"2023-10-09",{"date":193,"type":169},"2025-06-30",{"name":5,"class":6},1]