[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559082":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":52,"studyPopulation":42,"armGroups":53,"interventions":64,"overallOfficials":68,"centralContacts":72,"locations":81,"responsibleParty":193,"collaborators":195,"id":198,"slug":42,"hasResults":199,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":199,"sex":205,"minAge":206,"maxAge":42,"enrollmentInfo":207,"targetDuration":42,"studyType":210,"phases":211,"briefSummary":213,"conditions":214,"keywords":219,"overallStatus":84,"whyStopped":42,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"Pakistan Institute of Living and Learning","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Hierarchical composite score of all-cause mortality, all cause hospital readmissions and health related quality of life (EQ5D)","all-cause mortality followed by readmission rates and changes in health-related quality of life","Baseline to 12th month post randomization",[14,18,21,24,27,30,33,36,39],{"measure":15,"description":16,"timeFrame":17},"Patient Health Questionnaire (PHQ-9)","To screen, diagnose, monitor and measure the severity of depression","Baseline to 3 months, 6 months and 12-months post-intervention",{"measure":19,"description":20,"timeFrame":17},"Burns Specific Health Scale","To quantify dysfunction and distress across six major domains of health, specifically burn injury related morbidity",{"measure":22,"description":23,"timeFrame":17},"Rosenburg Self-Esteem Scale","A 10 item self-report instrument to measure individual self-esteem",{"measure":25,"description":26,"timeFrame":17},"Visual Analogue Scale","It provides subjective magnitude estimation and consists of a straight line with limits that carry a verbal description of each extreme of the symptom both pain relief or pain severity",{"measure":28,"description":29,"timeFrame":17},"International Trauma Questionnaire","It is a brief,18 item self-report questionnaire used to assess core features of Post-Traumatic Stress Disorder (PTSD) and Complex PTSD.",{"measure":31,"description":32,"timeFrame":17},"Perceived Stigma Questionnaire","It is used to measure stigmatizing behaviors commonly reported by people with appearance distinctions. Participants were asked to rate how often they experienced a behavior on a 5-point Likert scale",{"measure":34,"description":35,"timeFrame":17},"WHO disability assessment schedule","It is used to measure the impact of health condition, functioning, disability, monitor the effectiveness of interventions as well as the burden of disease both mental and physical disorders",{"measure":37,"description":38,"timeFrame":17},"Vancouver Scar Scale","It is used to document change in scar appearance. Index measures the scares on four parameters, Pigmentation, vascularity, pliability and heigh",{"measure":40,"description":41,"timeFrame":17},"Quality of life scale EQ-5D","Health-related quality of life as measured for mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":48,"maskingDescription":42,"whoMasked":49},"DOUBLE",[50,51],"INVESTIGATOR","OUTCOMES_ASSESSOR","The Burns trial will be conducted in six cities of Pakistan; Karachi, Hyderabad, Lahore, Rawalpindi, Peshawar and Quetta to compare integrated intervention with enhanced usual care. Participants will be randomized either to the intervention or enhanced usual care. The intervention consists of multiple culturally adapted components such as psychological bundle, emergency care, surgical and rehab bundle to improve care within burn units, transitional care, and patient and family rehabilitation (known as 'Integrated case management for improved psychosocial and physical rehabilitation of burn survivors and their families'). The comparator will be usual care (emergency, surgical and rehab care ) plus brief written self-help booklets will be given(enhanced usual care).\n\nThe intervention will be carried out by case managers (trained allied health professionals such as nurses, physiotherapists, psychologists etc) and will be started during hospital stay to enhance physical health outcomes by educating patients about self-care\u002F medications and adherence to treatment resources provided to the case managers and upon discharge to the participants and their carers.\n\nParticipants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital\u002Fcommunity and 2 follow-up sessions lasting 30 minutes in the community). Assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Integrated case manager care","EXPERIMENTAL","comprises 8 sessions delivered by case managers. Case managers will provide up to 6 low-intensity sessions in the hospital or the community (if the patient is discharged before completing the required sessions), with content and duration tailored to patient preferences. Post-discharge, patients will receive 2 follow-up sessions with case managers to ensure a smooth transition into the community.",[59],"Behavioral: Integrated case manager care",{"label":61,"type":62,"description":63,"interventionNames":42},"Enhanced care as usual","NO_INTERVENTION","includes their standard care, and all treatments recommended by attending physicians will be provided, plus a written self-help booklet",[65],{"type":66,"name":55,"description":57,"armGroupLabels":67,"otherNames":42},"BEHAVIORAL",[55],[69],{"name":70,"affiliation":5,"role":71},"Nasim Chaudhry, MD","PRINCIPAL_INVESTIGATOR",[73,78],{"name":74,"role":75,"phone":76,"phoneExt":42,"email":77},"Ameer Khoso, PhD Fellow","CONTACT","+92-2135871845","ameer.bukhsh@pill.org.pk",{"name":79,"role":75,"phone":76,"phoneExt":42,"email":80},"sehrish Tofique, PhD Fellow","Sehrishtofique@ymail.com",[82,95,103,115,128,136,144,156,167,175,181],{"facility":83,"status":84,"city":85,"state":86,"zip":42,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":42},"Burn Unit, Sandeman Provisional Hospital","RECRUITING","Quetta","Balochistan","Pakistan","PK",{"type":90,"coordinates":91},"Point",[92,93],67.00141,30.18414,{"lat":93,"lon":92},{"facility":96,"status":84,"city":85,"state":86,"zip":42,"country":87,"countryCode":88,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Plastic Surgery and Burn Unit, BMC, Quetta",{"type":90,"coordinates":98},[92,93],{"lat":93,"lon":92},[101],{"name":102,"role":75,"phone":42,"phoneExt":42,"email":42},"Dr Silsila Sherzad, MBBS",{"facility":104,"status":84,"city":105,"state":106,"zip":42,"country":87,"countryCode":88,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Burns and Plastic Surgery Center, Peshawar","Peshawar","KPK",{"type":90,"coordinates":108},[109,110],71.57849,34.008,{"lat":110,"lon":109},[113],{"name":114,"role":75,"phone":42,"phoneExt":42,"email":42},"Irfan Ullah",{"facility":116,"status":84,"city":117,"state":118,"zip":119,"country":87,"countryCode":88,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Department of Plastic, Reconstructive Surgery and Burn Unit, Kind Edward Medical University","Lahore","Punjab Province","203393",{"type":90,"coordinates":121},[122,123],74.35071,31.558,{"lat":123,"lon":122},[126],{"name":127,"role":75,"phone":42,"phoneExt":42,"email":42},"Mustehsan Bashir",{"facility":129,"status":84,"city":117,"state":118,"zip":42,"country":87,"countryCode":88,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"Jinnah Burn & Reconstructive Surgery Centre, Lahore",{"type":90,"coordinates":131},[122,123],{"lat":123,"lon":122},[134],{"name":135,"role":75,"phone":42,"phoneExt":42,"email":42},"Farrukh Aslam, FCPS",{"facility":137,"status":84,"city":138,"state":118,"zip":42,"country":87,"countryCode":88,"cosmosGeoPoint":139,"geoPoint":143,"contacts":42},"Pak Italian Modern Burn and Plastic Surgery Centre","Multan Khurd",{"type":90,"coordinates":140},[141,142],72.01752,33.03555,{"lat":142,"lon":141},{"facility":145,"status":84,"city":146,"state":147,"zip":42,"country":87,"countryCode":88,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Burn Centre, Civil Hospital Hyderabad","Hyderābād","Sindh",{"type":90,"coordinates":149},[150,151],68.37718,25.39689,{"lat":151,"lon":150},[154],{"name":155,"role":75,"phone":42,"phoneExt":42,"email":42},"Saadia Rasheed",{"facility":157,"status":84,"city":158,"state":147,"zip":119,"country":87,"countryCode":88,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Burn Centre, Ruth K. M. Pfau, Civil Hospital Karachi","Karachi",{"type":90,"coordinates":160},[161,162],67.0104,24.8608,{"lat":162,"lon":161},[165],{"name":166,"role":75,"phone":42,"phoneExt":42,"email":42},"Samia Tasleem",{"facility":168,"status":84,"city":158,"state":147,"zip":42,"country":87,"countryCode":88,"cosmosGeoPoint":169,"geoPoint":171,"contacts":172},"Burns and Plastic Surgery, Patel Hospital, Karachi",{"type":90,"coordinates":170},[161,162],{"lat":162,"lon":161},[173],{"name":174,"role":75,"phone":42,"phoneExt":42,"email":42},"Mazhar Nizam, FCPS",{"facility":176,"status":84,"city":177,"state":42,"zip":42,"country":87,"countryCode":88,"cosmosGeoPoint":42,"geoPoint":42,"contacts":178},"Allied Burn & Reconstructive Surgery Centre","Faisalābad",[179],{"name":180,"role":75,"phone":42,"phoneExt":42,"email":42},"Urwa Ahmed",{"facility":182,"status":84,"city":183,"state":42,"zip":184,"country":87,"countryCode":88,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Burn Care Centre, PIMS, Islamabad","Islamabad","46300",{"type":90,"coordinates":186},[187,188],73.04329,33.72148,{"lat":188,"lon":187},[191],{"name":192,"role":75,"phone":42,"phoneExt":42,"email":42},"Rehan Ahmed, MBBS",{"type":194,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[196],{"name":197,"class":6},"University of Manchester","100559082",false,"NCT06559501","Integrated Case Management for Burns Care in Pakistan","Integrated Case Management for Improved Psychosocial and Physical Rehabilitation of Burn Survivors and Their Families Treated in Pakistan","BURNS","Inclusion Criteria:\n\n* Adults 18 years and over\n* Accidental burn injury and meet the criteria for admission to burn centres\n* Clinician judgment for participation readiness\n* Ability to provide informed consent\n\nExclusion Criteria:\n\nNo intentional burn injuries\n\n• Lacking capacity to provide informed consent","ALL","18 Years",{"count":208,"type":209},1146,"ESTIMATED","INTERVENTIONAL",[212],"NA","To test whether a culturally adapted multicomponent intervention for improving burns care and patient\u002Ffamily rehabilitation is effective in improving survival among burn victims in Pakistan and is cost-effective. The comparator will be usual care plus brief written self-help advice (enhanced usual care). The study is designed as a multicentre, pragmatic, parallel group, individually randomised trial. Participants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital\u002Fcommunity and 2 follow-up sessions lasting 30 minutes in the community). Assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.",[215,216,217,218],"Unintentional Burn Injury","Depression","Anxiety","Burns",[220,221,222,223,87,224],"Burns Rehabilitation","culturally adapted","Cost effectiveness","Multicenter trial","Burns Injury","2025-07-29",{"date":227,"type":228},"2025-07-30","ACTUAL",{"date":230,"type":228},"2024-09-02",{"date":232,"type":209},"2026-10-31",{"name":5,"class":6},11]