[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557077":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":75,"collaborators":79,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":12,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":12,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":43,"whyStopped":12,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Glostrup University Hospital, Copenhagen","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"controlgroup","NO_INTERVENTION","There are no established standards for identifying and addressing self-management needs in rheumatology outpatient consultations. Participants allocated to the control group will receive usual care, which consists of planned sessions with a rheumatologist and occasionally a nurse, a physiotherapist, and an occupational therapist. Those who started DMARDs of any type had an appointment with a nurse and a follow-up phone call. All participants will have the possibility to contact the outpatient clinic and talk to a nurse. Participants in the control group will be encouraged to maintain their usual daily routines and self-management practices until the follow-up assessment is conducted.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"intervention group","EXPERIMENTAL","Participants allocated to the intervention group will receive the NISMA Intervention in addition to usual care.",[18],"Behavioral: Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention (NISMA)",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention (NISMA)","The NISMA intervention is a flexible intervention and comprises three mandatory individual sessions with a nurse, supplemented by two optional group sessions over a period of 12 months, to provide comprehensive support tailored to each participant's needs. The intervention is grounded in the theoretical framework Social Cognitive Theory and inspired by the questioning techniques in Acceptance and Commitment Therapy (ACT). These methods play a crucial role in helping participants enhance their self-efficacy. The key components of our approach include: a person-centered approach by addressing challenges identified by each participant to foster self-efficacy through targeted problem-solving and goal-setting. This is utilized by interviewing techniques derived from ACT to assist participants in accepting and committing to self-management. The program is designed to last between 6-12 months, allowing for gradual skill development and adaptation.",[14],[26],{"name":27,"affiliation":28,"role":29},"Bente A Esbensen","Rigshospitalet, Glostrup, Center for Rheumatology and Spine Diseases. COPECARE","PRINCIPAL_INVESTIGATOR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Luise H Lindgren","CONTACT","22509390","+ 45","luise.holberg.lindgren@regionh.dk",{"name":27,"role":33,"phone":38,"phoneExt":35,"email":39},"38624056","bente.appel.esbensen@regionh.dk",[41,62],{"facility":42,"status":43,"city":44,"state":12,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Rigshospitalet, Center for Rheummatology and Spine Diseases","RECRUITING","Glostrup Municipality","2600","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],12.40377,55.6666,{"lat":52,"lon":51},[55,58,61],{"name":56,"role":33,"phone":57,"phoneExt":12,"email":36},"Luise H Lindgren, Ph.d.","+4522509390",{"name":59,"role":33,"phone":60,"phoneExt":12,"email":39},"Bente A. Esbensen, Professor","+4525540828",{"name":59,"role":29,"phone":12,"phoneExt":12,"email":12},{"facility":63,"status":43,"city":64,"state":12,"zip":65,"country":46,"countryCode":47,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Holbæk sygehus","Holbæk","4300",{"type":49,"coordinates":67},[68,69],11.71279,55.7175,{"lat":69,"lon":68},[72],{"name":73,"role":33,"phone":12,"phoneExt":12,"email":74},"Line T Krogh, RN","ltkr@regionsjaelland.dk",{"type":29,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":78,"oldNameTitle":12,"oldOrganization":12},"Bente Appel Esbensen","Professor","Rigshospitalet, Denmark",[80,82],{"name":81,"class":6},"University Hospital Bispebjerg and Frederiksberg",{"name":83,"class":6},"Aarhus University Hospital","100557077","effect-of-a-self-management-intervention-for-patients-newly-diagnosed-with-inflammatory-arthritis-the-nisma-trial-100557077",false,"NCT06533423","Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: The NISMA Trial","Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: Study Protocol for a Randomized Controlled NISMA Trial","Inclusion Criteria:\n\nPatients will be included if they are adults aged 18 years or older with one of the following conditions:\n\n* Rheumatoid Arthritis (RA) with ICD-10 codes: M05.3, M05.9, M05.8, M06.9 diagnosed within the last 6 months\n* Psoriatic Arthritis (PsA) with ICD-10 codes: M073.A, M073.B diagnosed within the last 6 months\n* Axial Spondyloarthritis (axSpA) with ICD-10 codes: M45.9, M46.1, M46.8, M46.9, diagnosed within the last 12 months, and has initiated biological treatment\n\nPatients with axSpA will have unique inclusion criteria due to NSAIDs being the first-line pharmacological treatment. For those effectively treated with NSAIDs and exercise, treatment is transitioned to their general practitioner. Therefore, only those who have initiated biological treatment will be included.\n\nExclusion Criteria:\n\nPatients will be excluded if they:\n\n* have insufficient language skills to discuss the topics in the intervention in Danish\n* are receiving chemo-therapy treatment for malignancies\n* are pregnant\n* have severe mental illness.","ALL","18 Years","120 Years",{"count":95,"type":96},130,"ESTIMATED","INTERVENTIONAL",[99],"NA","Background:\n\nIn patients newly diagnosed with inflammatory arthritis, a self-management intervention is anticipated to enhance self-management skills, thereby improving patient function, well-being, and survival. The primary objective of the trial is to investigate the short-term efficacy of the NISMA intervention and usual care, compared to usual care alone (control group), on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis.\n\nMethod:\n\nThis study aims to test the efficacy of the \"Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention\" (NISMA) through a multicenter pragmatic randomized controlled trial (RCT). The trial will involve 130 patients newly diagnosed with IA from three Danish hospitals. Participants will be randomly assigned to either the NISMA intervention group or a control group receiving usual care. The NISMA intervention includes three mandatory individual sessions with a nurse, supplemented by two optional group sessions over 12 months.\n\nPrimary outcomes will be measured using the Health Education Impact Questionnaire (heiQ), focusing on the \"skill and technique acquisition\" domain. Secondary outcomes include other heiQ domains, quality of life, loneliness, physical function, pain intensity, pain, self-efficacy, anxiety and depression, fatigue, patient global assessment, disease activity, and medication adherence. Data will be collected at baseline, 12 months, and 18 months post-baseline.\n\nDiscussion:\n\nThis RCT will provide essential insights into the effectiveness of a targeted self-management intervention for patients newly diagnosed with IA. The NISMA intervention, developed following the Medical Research Council Framework for complex interventions, aims to improve self-management skills and overall QoL. By addressing the unique challenges faced by newly diagnosed patients, this study seeks to enhance the initial management of IA, aligning with the European Alliance of Associations for Rheumatology (EULAR) recommendations for self-management support. If successful, the NISMA intervention could represent a significant advancement in the non-pharmacological management of IA, offering a comprehensive, patient-centered approach that addresses both physical and psychological needs.",[102],"Inflammatory Arthritis",[104,105,106,107,108,109,110],"self-management","rheumatoid arthritis","axial spondyloarthritis","psoriatic arthritis","newly diagnosed","heiQ","quality of life","2026-02-05",{"date":113,"type":114},"2026-02-09","ACTUAL",{"date":116,"type":114},"2024-12-09",{"date":118,"type":96},"2028-05-30",{"name":5,"class":6},2]