Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-02-01 @ 10:41 AM
Study NCT ID:
NCT03170466
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2017-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Palliative Care in Heart Failure: A Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-21', 'size': 176260, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-10-02T09:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2017-05-22', 'studyFirstSubmitQcDate': '2017-05-25', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of enrolling 30 patients via attempting to enroll 30 patients', 'timeFrame': 'One year', 'description': 'We will assess the feasibility of enrolling 30 patients by attempting to enroll 30 patients.'}], 'secondaryOutcomes': [{'measure': 'Intervention Acceptability', 'timeFrame': 'Two years', 'description': 'We will evaluate acceptability of the intervention through interviews with patients, caregivers, and healthcare providers.'}, {'measure': 'Intervention Fidelity via the Intervention Fidelity Monitoring Report', 'timeFrame': 'Two years', 'description': 'We will assess intervention fidelity by audio-recording the interventions and having independent reviewers listen to them and complete our Intervention Fidelity Monitoring Report.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Palliative care'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Patients with advanced heart failure (HF) typically experience significant burdens that negatively impact their quality of life. Although palliative care has been shown to improve patient outcomes in other serious illnesses, insufficient data exist to support its use in HF. Furthermore, the demand for palliative care in serious illness outstrips the available supply of certified palliative care clinicians. This pilot trial will assess the feasibility and acceptability of training cardiology nurses in basic palliative care skills and their ability to deliver this care alongside usual HF management.', 'detailedDescription': "Patients with advanced heart failure (HF) suffer from significant pain, fatigue, difficulty breathing, anxiety, and depression. Palliative Care (PC) is a medical specialty designed to focus on relieving patient suffering by providing an extra layer of support on top of usual care. To date, there has been little research on the impact of PC in HF. We will conduct a randomized clinical trial to assess the feasibility, acceptability, and perceived effectiveness of training cardiology nurses in PC and administering PC to their patients. Patients will be randomized into either the usual care group or the intervention group. Usual care participants will receive their care with no alterations, and intervention participants will receive the PC intervention from their nurse on top of their usual care. Both groups will complete health-related surveys on tablet computers, via email, and/or via telephone. In the intervention group, these answers will be used to tailor the intervention to the specific patient's needs. Caregivers will also be recruited into the study, and will complete surveys similar to the patients via the aforementioned methods."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New York Heart Association Class III or IV Heart Failure\n* 2 or more hospitalizations in the past year due to Heart Failure\n\nExclusion Criteria:\n\n* Less than 40 years old\n* Currently awaiting a transplant\n* Received outpatient palliative care within the past 12 months\n* Pregnant or intends to be within the next 12 months\n* No regular phone access\n* Not fluent in English\n* Failed the Callahan 6-item Screener\n* Does not intent to regularly attend clinic for the next 12 months'}, 'identificationModule': {'nctId': 'NCT03170466', 'briefTitle': 'Primary Palliative Care in Heart Failure: A Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Primary Palliative Care in Heart Failure: A Pilot Trial', 'orgStudyIdInfo': {'id': 'PRO16090248'}, 'secondaryIdInfos': [{'id': 'K01HL133466-01', 'link': 'https://reporter.nih.gov/quickSearch/K01HL133466-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primary Palliative Care', 'description': "The intervention will be delivered through four primary mechanisms. First, an existing HF nurse will deliver the intervention to patients during regularly scheduled visits. Second, telephone calls will reinforce topics. Third, patients will regularly report symptoms through the MyUPMC patient portal. Fourth, the nurse will act as a liaison to communicate concerns to the patient's cardiologist and primary care physician, as well as facilitating other resources (e.g., home health). In addition, follow-up assessments will be completed via phone or email at least 2 weeks post-intervention delivery. Caregivers will complete surveys during the first in-person visit and then during the follow-up assessments.", 'interventionNames': ['Behavioral: Primary Palliative Care']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients randomized to the control arm of this study will continue to receive the standard of high-quality HF care provided to all patients. Control patients may still receive palliative care outside of the study.'}], 'interventions': [{'name': 'Primary Palliative Care', 'type': 'BEHAVIORAL', 'otherNames': ['Supportive care'], 'description': 'The intervention will span 4 domains: symptom management (e.g., dyspnea), psychosocial support (e.g., anxiety), advance care planning (e.g., understanding prognosis and electing a proxy) and care coordination (e.g., communication across providers).', 'armGroupLabels': ['Primary Palliative Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15131', 'city': 'White Oak', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Heart Vascular Institute', 'geoPoint': {'lat': 40.33757, 'lon': -79.80921}}], 'overallOfficials': [{'name': 'Dio Kavalieratos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Robert Arnold', 'investigatorAffiliation': 'University of Pittsburgh'}}}}