Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-01-03 @ 12:15 PM
Study NCT ID:
NCT03246035
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2017-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2017-06-28', 'studyFirstSubmitQcDate': '2017-08-09', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause death, hospital readmission, or ED revisit', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Rate of return visits to any ER for any medical issue', 'timeFrame': '30 days', 'description': 'Number of times enrolled patient visits an emergency department for any medical issue, over the 90 day follow-up period.'}, {'measure': 'Rate of admission to hospital at 90 days', 'timeFrame': '90 days', 'description': 'Number of times the patient needs to be admitted to hospital for any medical issue, over the 3 month follow-up period.'}, {'measure': 'Incidence of adverse effects from medication', 'timeFrame': '90 days', 'description': 'Number of patients who experience unexpected side effects from their heart failure medications'}, {'measure': 'Self-Care Index', 'timeFrame': '90 days', 'description': 'Change in the Self-Care Heart Failure Index from enrollment to follow-up'}, {'measure': 'Heart Failure Symptom Scale', 'timeFrame': '90 days', 'description': 'Change in the 12 point Heart Failure Symptom Scale from enrollment to follow-up'}, {'measure': 'Frailty Index', 'timeFrame': '90 days', 'description': 'Change in the Frailty Index from enrollment to follow-up'}, {'measure': 'Recruitment rate', 'timeFrame': '90 days', 'description': 'The number of eligible of patients recruited into the study over a 3 month trial period'}, {'measure': 'Attrition rate', 'timeFrame': '90 days', 'description': 'The number of patients enrolled the study who choose to leave the study before completing the follow-up'}, {'measure': 'Informed consent validation (qualitative)', 'timeFrame': '90 days', 'description': 'Qualitative feedback from participants regarding the informed consent process'}, {'measure': 'All-cause death, hospital readmission, or ED revisit', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Decompensated Heart Failure', 'Heart Failure', 'Frailty', 'Geriatrics', 'Self-care', 'Emergency Medicine', 'Cardiology', 'Patient Oriented Research'], 'conditions': ['Heart Failure', 'Acute Decompensated Heart Failure', 'Fragility', 'Emergencies']}, 'referencesModule': {'availIpds': [{'id': 'CODIM-MBM-17-052', 'url': 'http://www.ladydavis.ca/en/jonathanafilalo', 'type': 'Study Protocol', 'comment': 'Pilot study protocol'}, {'id': 'CODIM-MBM-17-052', 'url': 'http://www.ladydavis.ca/en/jonathanafilalo', 'type': 'Informed Consent Form', 'comment': 'Patient consent Caregiver consent French and English available'}]}, 'descriptionModule': {'briefSummary': 'A randomized study designed to determine whether telephone based interventions can prevent return hospital visits for elderly and frail patients with acute symptoms of heart failure. Specifically, the intervention will improve patients ability to monitor and address self care of heart failure at home.', 'detailedDescription': 'Acute decompensated heart failure (ADHF) is a common illness in Canadian emergency departments (ED). The frail subset of elderly patients with ADHF is challenging to treat, use a large proportion of available resources, and are at higher risk for complications, including readmission to hospital after discharge. The investigators believe that by improving access to follow-up, optimizing self-care, and addressing the various cognitive and physical limitations of frailty, it will be possible to improve quality of life and reduce readmission rates for frail patients with ADHF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who presented to the ED and who are being discharged with a primary or secondary diagnosis of ADHF\n* Age ≥ 65\n* Frailty, defined as a FRAIL score \\>=3/5 or Clinical Frailty Scale (CFS) score \\>=5/9\n* Informed consent provided by the patient or proxy\n\nExclusion Criteria:\n\n* Significant dementia or active delirium\n* Severe frailty, defined as a CFS score \\>=8/9\n* Prohibitive language barrier\n* Primary address outside of Quebec\n* Patient deemed to be palliative or moribund by treating team'}, 'identificationModule': {'nctId': 'NCT03246035', 'acronym': 'HFF-ED', 'briefTitle': 'Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Jewish General Hospital'}, 'officialTitle': 'A Prospective Randomized Pilot Trial to Reduce Readmission for Frail Elderly Patients With Acute Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'ADHF-ED-JGH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group (Standard Care)', 'description': 'The control group will receive outpatient follow-up, medication advice and lifestyle guidance as prescribed at discharge from the ED or hospital.', 'interventionNames': ['Other: Control Group (Standard Care)']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The intervention will consist of contacting the patient 5 days post-discharge and arranging definitive outpatient follow-up and providing targeted medical and lifestyle advice based on deficient domains identified at baseline.', 'interventionNames': ['Behavioral: Intervention Group']}], 'interventions': [{'name': 'Intervention Group', 'type': 'BEHAVIORAL', 'description': "For the intervention arm, a specialized heart failure nurse practitioner will contact the patient or their primary caregiver by telephone within 5 days post-discharge and send them an education packet by mail. During the telephone call, the nurse will (1) confirm the patient's scheduled follow-up appointment in cardiology, (2) provide recommendations for heart failure self-care behaviors that were found to be deficient at baseline. Patients will then be referred to a Geriatrics Assessment Team, who will provide individualized recommendations for frailty domains that were found to be deficient at baseline. The technique used to provide educational recommendations will be motivational interviewing.", 'armGroupLabels': ['Intervention Group']}, {'name': 'Control Group (Standard Care)', 'type': 'OTHER', 'description': 'For patients randomized to the Control Group (Standard Care), they will receive their follow-up visits, medications, diet and physical activity advice as they normally would. This is the care they would receive even if they were not enrolled in the study', 'armGroupLabels': ['Control Group (Standard Care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jonathan Afilalo, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jewish General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Association of Emergency Physicians', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Jonathan Afilalo', 'investigatorAffiliation': 'Jewish General Hospital'}}}}