[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627230":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":68,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":12,"enrollmentInfo":84,"targetDuration":12,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":100,"whyStopped":12,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Medstar Health Research Institute","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual care","NO_INTERVENTION","The usual care arm will consist of routine LVAD care with clinician-triggered referral for palliative care specialist evaluation.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Palliative care intervention","ACTIVE_COMPARATOR","The palliative care arm mirrors the intervention described in a cohort of patients with HF in the PAL-HF trial. The intervention will be conducted by a palliative care specialist nurse clinician with standardized training in administering the intervention. The palliative care clinician will conduct visits within 2 weeks of randomization\u002Fenrollment and subsequently approximately every 4-6 weeks with the patient for 6 months total duration. The patient will be referred for interdisciplinary supportive care from the palliative care chaplain, social worker, and\u002For pharmacist based on NP evaluation. Additionally, based on baseline clinical assessment scales and symptoms, patients will be offered supportive medications or referrals for cardiac rehabilitation and behavioral health\u002Fpsychiatry.",[18],"Behavioral: Palliative care intervention",[20],{"type":21,"name":14,"description":16,"armGroupLabels":22,"otherNames":23},"BEHAVIORAL",[14],[24],"PC intervention",[26],{"name":27,"affiliation":5,"role":28},"Richa Gupta, MD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},"Richa Gupta, MD MPH","CONTACT","202-877-4698","richa.gupta@medstar.net",[36,52],{"facility":37,"status":12,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"MedStar Washington Hospital Center","Washington D.C.","District of Columbia","20010","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-77.03637,38.89511,{"lat":47,"lon":46},[50,51],{"name":31,"role":32,"phone":33,"phoneExt":12,"email":34},{"name":31,"role":28,"phone":12,"phoneExt":12,"email":12},{"facility":53,"status":12,"city":54,"state":55,"zip":56,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Inova Schar Heart and Vascular Institute","Fairfax","Virginia","22042",{"type":44,"coordinates":58},[59,60],-77.30637,38.84622,{"lat":60,"lon":59},[63,67],{"name":64,"role":32,"phone":65,"phoneExt":12,"email":66},"Anirudh Rao, MD","703-776-4289","anirudh.rao@inova.org",{"name":64,"role":28,"phone":12,"phoneExt":12,"email":12},{"type":69,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[71],{"name":72,"class":73},"Inova Schar Heart and Vascular","UNKNOWN","100627230","palliative-care-intervention-to-improve-health-related-quality-of-life-for-patients-on-long-term-lvad-support-100627230",false,"NCT07445932","Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support","The PALL-VAD Study: Palliative Care Intervention to Improve Health Related Quality of Life for Patients With Heart Failure on Long-Term LVAD Support: A Pilot, Prospective, Randomized Trial","PALL-VAD","Inclusion Criteria:\n\n* LVAD patients \\>= 18 years of age\n* \\>= 1 year post-LVAD implantation\n\nExclusion Criteria:\n\n* Listed for heart transplantation. Undergoing evaluation for heart transplantation, however, is not an exclusion.\n* Non-English speaking\n* Receiving outpatient palliative care in the last 6 months\n* Renal replacement therapy\n* Non-cardiac terminal illness\n* Women who are pregnant or planning to become pregnant\n* Inability to comply with study protocol and follow up\n* Inabilty to provide consent.\n* Cognitive impairment or intellectual disability that prohibits successful completion of the HRQoL scales or compliance with the study protocol and follow up.","ALL","18 Years",{"count":85,"type":86},90,"ESTIMATED","INTERVENTIONAL",[89],"NA","Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL). Palliative care specialists are key members of the multidisciplinary care team for patients with long-term-LVAD (LT-LVAD), offering specialized, comprehensive, holistic care.\n\nProblem: A seminal study of palliative care in patients with heart failure (PAL-HF trial) demonstrated that outpatient palliative care improved HRQoL, depression, anxiety, and spiritual well-being compared to usual care. The impact of longitudinal palliative care on HRQoL in LT-LVAD patients is unknown.\n\nObjective: The investigators aim to conduct the first study examining a palliative care intervention to improve HRQoL among LT- LVAD recipients (patients who have lived with LT-LVAD for at least six months and are not heart transplant candidates) at two centers (MedStar Health and Inova) in the Mid-Atlantic Region. Given the demographics of the study institutions, the investigators anticipate a socioeconomically and racially diverse cohort of patients with subgroups who may disproportionately experience LVAD-related burdens relative to benefits.\n\nAims: The first aim is to assess baseline measures of HRQoL in LT-LVAD patients to understand differences in HRQoL across subgroups and multiple, understudied domains. The second aim is to test the feasibility and acceptability of a randomized, unblinded pilot study of a palliative care interdisciplinary intervention in this population.\n\nSignificance: Results of this study will inform the development of a large randomized controlled trial to test the effectiveness of palliative care intervention in improving HRQoL in LT-LVAD patients. If results are positive, this will revolutionize the post-LVAD treatment paradigm, by making palliative care integration the standard of care for longitudinal LT-LVAD patient management.",[92,93,94,95],"Advanced Heart Failure","Mechanical Circulatory Support","Left Ventricular Assist Device","Palliative Care",[97,98,99],"advanced heart failure","left ventricular assist device","palliative care","NOT_YET_RECRUITING","2026-02-25",{"date":103,"type":104},"2026-03-03","ACTUAL",{"date":106,"type":86},"2026-03-01",{"date":108,"type":86},"2027-03-01",{"name":5,"class":6},2]