[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595340":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Padova","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The video recordings will be made available to patients randomized to the experimental\u002Fintervention group by providing a QR code linked to the Youtube or other similar platform in order to be played by a digital device already available to patients and caregivers. It will be played for the first time at the end of the first study visit after all assessments have been completed. Patients and caregivers will be encouraged to play the video recordings as they need and prefer.",[13],"Other: educational video",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","The control group will not receive the additional educational video but will receive the standard of care and an educational pamphlet.",[19],"Other: educational pamphlet (standard educational intervention)",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"educational video","The experimental educational intervention will consist of professional video recordings that will cover the following topics:\n\n1. Disease knowledge (VLU)\n2. Medication management\n3. The importance of compression therapy\n4. Diet and physical activity The video recordings' contents will result from a review of the literature and guidelines, which will be later reviewed by a panel of experts in VLU. The video will be recorded by experienced video-maker and by a group of volunteers who will be the actors.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"educational pamphlet (standard educational intervention)","The educational brochure is an educational intervention already in use at the setting involved in the study.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Matteo Martinato, RN, PhD","CONTACT","+393472306806","matteo.martinato@ubep.unipd.it",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Azienda ULSS 6 Euganea","Padova","PD","35131","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],11.14261,44.38225,{"lat":48,"lon":47},[51,55],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":54},"Flavia Masiero, RN","+393472104810","flavia.masiero@aulss6.veneto.it",{"name":56,"role":57,"phone":25,"phoneExt":25,"email":25},"Pandini Micaela, RN, MSc","PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[61],{"name":62,"class":6},"Azienda Ulss 6 Euganea","100595340","educational-interventions-in-venous-leg-ulcer-100595340",false,"NCT07031180","Educational Interventions in Venous Leg Ulcer","The Effect of an Educational Intervention in Patient's Knowledge and Self-care Skills in Adult Patients With Venous Leg Ulcer in Outpatient Clinic of \"Azienda ULSS 6 Euganea\": a Two-arm, Single Centre Randomized Controlled Trial","Inclusion Criteria:\n\n* older than 18 years;\n* with venous leg ulcer;\n* who understand Italian language;\n* who is able to read and understand the questions;\n* who attending to the nursing clinics involved in the study;\n* who have given consent to participate in the study;\n* who use a smart device with an internet connection or with caregiver able to provide the smart device as video player.\n\nExclusion Criteria:\n\n* with cognitive impairment;\n* who have an ankle-arm index\u002FWinsor's index (ABI) less than 0.90. \u002F with arterial insufficiency\n* patients with arterial or mixed-origin ulcers","ALL","18 Years",{"count":73,"type":74},142,"ESTIMATED","INTERVENTIONAL",[77],"NA","Background: Venous ulcers are skin lesions caused by impaired blood circulation. In Western countries, about 1% of the population is affected, and approximately 3% those over 80 years old. Venous leg ulcers tend to become chronic; a lesion is defined as chronic when it does not progress towards spontaneous healing. The treatment of these lesions inevitably involves long healing times, which results in increased healthcare costs. Moreover, venous leg ulcers have recurrence rates ranging from 18% to 28%. For this reason, it is important to support patients affected by or at risk of venous ulcers during their healing process or for prevention.\n\nObjectives: The primary objective of the study is to assess the superiority of the educational interventions to the standard therapeutic education, in improving the patient's\u002Fcaregiver's self-efficacy, after 4 weeks, 3, 6 and 12 months from the educational intervention begin. The secondary objectives are to clinically assess the impact of the educational intervention in decreasing healing time and recurrence rates and in patients' well-being after 12 months of follow-up. Additionally, the Well-being of Wounds Inventory (WOW-I) questionnaire will be validated in its Italian version.\n\nMethods: the study is a two arm moncentric randomized-controlled trial. The participants will be randomly assigned into two groups. The control group will receive an educational intervention through a pamphlet, which represents the standard education received in the outpatient clinics involved in the study. The intervention group instead will receive an experimental educational intervention through video played specifically for this study. The socio-demografic, health and ulcer related factors will be collected and the questionnaires: venous leg ulcer knowledge (VLUK), Venous Leg Ulcer Self-Efficacy Tool (VeLUSET) and Well-being Of Wounds Inventory (WOW I) will be administered to the patients during the outpatient clinic visit, before the treatment and after 4 weeks, 3 and 6 months after the intervention. The study also includes a telephonic follow up at 12 months from the start carried out to assess if the patient's venous ulcer has healed or recurred.",[80],"Venous Leg Ulcers",[82,83,84,85,86],"venous leg ulcer","education","randomized controlled trial","knowledge","self-care skills","NOT_YET_RECRUITING","2025-06-29",{"date":90,"type":91},"2025-07-03","ACTUAL",{"date":93,"type":74},"2025-09",{"date":95,"type":74},"2027-03",{"name":5,"class":6},1]