[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621624":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":102,"collaborators":106,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":126,"minAge":127,"maxAge":18,"enrollmentInfo":128,"targetDuration":18,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":18,"overallStatus":77,"whyStopped":18,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Queen's University, Belfast","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Carers","EXPERIMENTAL","180 informal carers of people with symptomatic heart failure across the three collaborating centres (Northern Ireland, England, and Scotland). These carers will receive the HEart faiLure carer support Programme (HELP).",[13],"Behavioral: HEart faiLure carer support Programme (HELP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Patients with symptomatic heart failure","NO_INTERVENTION","The patients who are receiving support from the recruited carers will be invited to provide outcome data (approximately 180), which will enable an assessment of the dyadic impact of HELP.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","HEart faiLure carer support Programme (HELP)","A 6-week, psychoeducational intervention consisting of two components: 1) Online support group sessions and 2) Educational booklet and supplementary website. A weekly online support group session will be delivered over 6 weeks via ZOOM by local specialist heart failure nurses. Each session will consist of 12 carers and last approximately 60 minutes. The sessions will initiate with a presentation (approximately 20 minutes in duration) on the allocated topic, including questions and group discussions throughout.\n\nCarers will complete self-directed learning across the educational booklet and website, which will complement the support group sessions.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Gareth Thompson, PhD","CONTACT","07714198795","gareth.thompson@qub.ac.uk",{"name":32,"role":28,"phone":18,"phoneExt":18,"email":33},"Donna Fitzsimons, PhD, RN","D.Fitzsimons@qub.ac.uk",[35,52,62,75,89],{"facility":36,"status":37,"city":38,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Royal Victoria Hospital","NOT_YET_RECRUITING","Belfast","United Kingdom","UK",{"type":42,"coordinates":43},"Point",[44,45],-5.92541,54.59682,{"lat":45,"lon":44},[48],{"name":49,"role":28,"phone":50,"phoneExt":18,"email":51},"Lana Dixon","028 9024 0503","lana.dixon@belfasttrust.hscni.net",{"facility":53,"status":37,"city":38,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Ulster Hospital",{"type":42,"coordinates":55},[44,45],{"lat":45,"lon":44},[58],{"name":59,"role":28,"phone":60,"phoneExt":18,"email":61},"Patrick Donnelly","028 9048 4511","patrick.donnelly@setrust.hscni.net",{"facility":63,"status":37,"city":64,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Craigavon Area Hospital","Craigavon",{"type":42,"coordinates":66},[67,68],-6.387,54.44709,{"lat":68,"lon":67},[71],{"name":72,"role":28,"phone":73,"phoneExt":18,"email":74},"Edith Donnelly","028 3833 4444","Edith.Donnelly@southerntrust.hscni.net",{"facility":76,"status":77,"city":78,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Glasgow Royal Infirmary","RECRUITING","Glasgow",{"type":42,"coordinates":80},[81,82],-4.25763,55.86515,{"lat":82,"lon":81},[85],{"name":86,"role":28,"phone":87,"phoneExt":18,"email":88},"Yvonne Millerick","0141 211 4000","yvonne.millerick@nhs.scot",{"facility":90,"status":37,"city":91,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"King's College Hospital","London",{"type":42,"coordinates":93},[94,95],-0.12574,51.50853,{"lat":95,"lon":94},[98],{"name":99,"role":28,"phone":100,"phoneExt":18,"email":101},"Hannah Simmons","020 3299 9000","hannah.simmons1@nhs.net",{"type":103,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Gareth Thomson","Project Manager",[107,109,112,114,116],{"name":108,"class":6},"Belfast Health and Social Care Trust",{"name":110,"class":111},"Southern Health and Social Care Trust","OTHER_GOV",{"name":113,"class":6},"South Eastern Health and Social Care Trust",{"name":115,"class":6},"King's College Hospital NHS Trust",{"name":76,"class":6},"100621624","heart-failure-carer-support-programme-implementation-testing-in-the-uk-100621624",false,"NCT07373041","Heart Failure Carer Support Programme: Implementation Testing in the UK.","Implementation Testing of the Heart Failure Carer Support Programme in the United Kingdom.","HELP","Carers\n\nInclusion Criteria\n\n1. Aged 18 years or older\n2. Physical and mental ability to operate a digital device, engage comfortably in conversation with peers, and be able to read written materials\n3. Caring (regular, unpaid care) for a person with a clinical diagnosis of heart failure (HF) who is receiving standard evidence-based HF therapies and has either HF symptoms or 1 episode of decompensation (symptoms requiring medical attention) in previous 6 months\n4. Ability to speak and understand English\n\nExclusion criteria\n\n1. Lacking capacity to give consent\n2. Under the age of 18\n\nPatients\n\nInclusion Criteria\n\n1. Aged 18 years or older\n2. Physical and mental ability to engage comfortably in conversation and be able to read written materials\n3. Clinical diagnosis of HF and receiving standard evidence-based HF therapies and has either HF symptoms or 1 episode of decompensation (symptoms requiring medical attention) in previous 6 months\n4. Ability to speak and understand English\n5. Receiving regular, unpaid support with managing his \u002F her condition from a loved one or friend (e.g., a relative or spouse)\n\nExclusion criteria\n\n1. Lacking capacity to give consent\n2. Under the age of 18\n3. Carer refused to participate in HELP",true,"ALL","18 Years",{"count":129,"type":130},360,"ESTIMATED","INTERVENTIONAL",[133],"NA","Background:\n\nHeart failure (HF) is widespread in the United Kingdom (UK). Many of these patients rely on support from family carers who are ill-prepared and supported for this role. These carers often experience poor mental and physical health because of their caring role. HEart faiLure carer support Programme (HELP) is the first intervention in the UK developed with carers of patients with HF to support them with looking after themselves and the patients they care for.\n\nAim:\n\nTo identify the best way of delivering HELP to all carers across the UK and evaluate its impact on carers and patients.\n\nMethods:\n\nHF Nurses will deliver HELP across 3 sites in the UK to approximately 180 carers of patients with HF. The carers targeted will be those who require additional support (caring for a patient who has HF symptoms). These carers will be nominated for the project by patients identified by nurses at in- and out-patient HF appointments. These patients (around 180) will also be invited to provide information for the project. HELP includes 6 online educational support sessions (1 hour each) delivered weekly, along with an educational booklet and website that provide additional support and advice. We will evaluate the impact of HELP on outcomes for patients (i.e., hospital admissions, GP visits, and quality of life) and carers (i.e., burden, preparedness, and quality of life). Interviews and logs \u002F questionnaires will be completed by participants and staff, which will help us understand how best to deliver HELP. Information for the project will be collected at baseline, during HELP, immediately post-HELP (6 weeks), and 6 months after finishing HELP.\n\nImpact:\n\nThe findings will allow us to develop a plan for giving HELP to all carers throughout the UK to provide them with the education and support they need.",[136,137,138],"Heart Failure","Care Givers","Self Management","2026-05-29",{"date":141,"type":142},"2026-06-02","ACTUAL",{"date":139,"type":142},{"date":145,"type":130},"2027-11-29",{"name":5,"class":6},5]