[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642993":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":36,"collaborators":25,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":25,"enrollmentInfo":50,"targetDuration":25,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":68,"whyStopped":25,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":25},{"fullName":5,"class":6},"G. d'Annunzio University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Telenursing Education Program with Video Pills and Teleconsultations","EXPERIMENTAL","Participants assigned to the intervention group will receive, in addition to standard care, a personalised six-month telenursing educational programme including video pills and nurse-led teleconsultations. Six video pills (5-8 minutes) will be sent monthly via email before each teleconsultation and will cover key aspects of multiple sclerosis management. Materials will be developed using Patient and Public Involvement principles with a multidisciplinary team and patient representatives. The programme includes six monthly teleconsultations via a telemedicine platform to assess understanding, support symptom and disability management, identify informational needs, and promote adherence (20-30 minutes each). Prior to the intervention, participants will receive telephone support to access the platform. Teleconsultations will be tailored to health literacy levels using appropriate communication strategies.",[13],"Other: TELESM-edu.nursing",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Patient Education Program","ACTIVE_COMPARATOR","The standard programme involves physicians and healthcare professionals, particularly nurses, providing patients with information about the disease, care pathway, and clinical management. It also includes guidance on selecting reliable information sources and addressing patients' questions and informational needs throughout the care process.",[19],"Other: Standard",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"TELESM-edu.nursing","The teleconsultation intervention will be tailored according to participants' health literacy (HL) levels, adapting content complexity, information load, language, interaction style, and methods to verify understanding, while maintaining consistent participation goals.\n\nFor patients with low HL, the intervention will focus on simplifying and progressively structuring information, prioritising essential and practical content. Understanding will be assessed using teach-back and Teach-to-Goal strategies. Nurses will provide supportive materials, including brochures with images, diagrams, and key messages, sent via email after each session.\n\nFor patients with adequate HL, the intervention will include more in-depth content and encourage critical discussion. Additional educational materials and reliable online resources will be provided after teleconsultations to support further learning.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard","The standard informational and educational programme provides that the physician and the health professionals involved in the care pathway, in particular the nurse, furnish patients taken care of at the Centre with information regarding the disease, the therapeutic and care pathway, and the management of the clinical condition. The standard intervention includes education on informed selection of information sources relevant to patients' areas of interest, and the clarification of any questions or informational requests that arise during the care pathway.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Valentina Simonetti, Associate Professor","CONTACT","+39 (0871) 541205","v.simonetti@unich.it",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Valentina Simonetti","Associate Professor","100642993","telesm-edunursing-a-personalised-nursing-intervention-for-people-with-multiple-sclerosis-100642993",false,"NCT07640698","TELESM-edu.Nursing: a Personalised Nursing Intervention for People With Multiple Sclerosis","TELESM-edu.Nursing: Efficacy of a Personalised Nursing Intervention for the Management of People With Multiple Sclerosis","TELESM-edu","Inclusion Criteria:\n\n* Patients of both sexes (male and female)\n* Age 18 years or older\n* Confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), or secondary progressive multiple sclerosis (SPMS)\n* Currently receiving pharmacological treatment for multiple sclerosis\n* Expanded Disability Status Scale (EDSS) score of 7.5 or lower\n* Ability to read and understand Italian\n* Ability to provide written informed consent\n* Access to a suitable device (smartphone, tablet, or computer with a webcam)\n* Access to a home internet connection\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Expanded Disability Status Scale (EDSS) score higher than 7.5\n* Presence of psychiatric disorders that may interfere with participation in the study\n* Presence of cognitive impairment that may interfere with participation in the study","ALL","18 Years",{"count":51,"type":52},110,"ESTIMATED","INTERVENTIONAL",[55],"NA","The primary aim of this study is to evaluate the impact of the telenursing intervention \"TELESM-edu.nursing\" on people with Multiple Sclerosis (pwMS), specifically focusing on their navigational capacity within the healthcare system (Navigation Health Literacy) and their perceived level of Health Literacy.\n\nThe study will also assess the effectiveness of the intervention in improving patient satisfaction with current therapy, patients' beliefs and attitudes towards the prescribed therapeutic regimen, satisfaction of informational needs, trust in nurses, and degree of disability.\n\nThe secondary objective is to evaluate the feasibility and sustainability of a personalised telenursing programme for pwMS. Feasibility will be assessed based on: (I) the ability to recruit and retain participants, measured through adherence rates and dropout rates in the intervention group; (II) participants' acceptability, usability, and satisfaction with the intervention; and (III) healthcare staff satisfaction and perceived usability of the intervention.\n\nThe main research questions addressed in this study are:\n\nDoes the \"TELESM-edu.nursing\" intervention improve patients' Navigation Health Literacy and overall Health Literacy levels? Does the intervention improve patient satisfaction with therapy and fulfilment of informational needs? Does the intervention positively influence patients' beliefs and attitudes towards their treatment? Does the intervention increase trust in nurses? What is the impact of the intervention on patients' level of disability? Is the telenursing programme feasible, acceptable, and sustainable for both patients and healthcare professionals?\n\nBoth study groups will receive the standard in-person informational and educational programme, as well as routine follow-up visits according to the established care pathway. Participants assigned to the intervention group will additionally receive a personalised educational programme lasting six months. This programme will be delivered monthly by a nurse through educational video pills and nurse-led teleconsultations.\n\nParticipants will be required to watch the video pills and take part in teleconsultations.",[58,59],"Multiple Sclerosis (MS)","Telenursing",[59,61,62,63,64,65,66,67],"Navigation Health Literacy","Health Literacy","Needs Assessment","Nurses","Therapeutics","Multiple sclerosis","Disability Evaluation","NOT_YET_RECRUITING","2026-06-05",{"date":71,"type":72},"2026-06-11","ACTUAL",{"date":74,"type":52},"2026-07",{"date":76,"type":52},"2027-06",{"name":5,"class":6}]