Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT03044535
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Support Measures of Adjustment and QOL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 895}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creation of new MCS A-QOL item banks and short forms and validation of existing instruments', 'timeFrame': 'Longitudinally: baseline through 6 months post-MCS implant and cross-sectionally through 10 years post-MCS implant', 'description': 'Psychometric measurement methods will be used to create new "item banks" (sets of items that comprise carefully calibrated questions which define and quantify a common theme) and short forms from our existing MCS A-QOL item pools (library of relevant items). Psychometric properties (e.g., reliability, validity, etc) of these new measures and existing instruments, some of them modified, will be evaluated, in order to provide evidence of their clinical utility for measuring adjustment to MCS and HRQOL.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quality of life', 'mechanical circulatory support'], 'conditions': ['Quality of Life', 'Heart Failure', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '40485994', 'type': 'DERIVED', 'citation': 'Hahn EA, Allen LA, Cella D, Beiser DG, Denfeld QE, Kirklin J, Lindenfeld J, McIlvennan CK, Ruo B, Teuteberg J, Kiernan M, Klein L, Lee CS, Murks C, Rich J, Stehlik J, Walsh MN, Bedjeti K, Grady KL. Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL study. JHLT Open. 2025 Apr 22;9:100269. doi: 10.1016/j.jhlto.2025.100269. eCollection 2025 Aug.'}, {'pmid': '37591454', 'type': 'DERIVED', 'citation': 'Grady KL, Kallen MA, Beiser DG, Lindenfeld J, Teuteberg J, Allen LA, McIlvennan CK, Rich J, Yancy C, Lee CS, Denfeld QE, Kiernan M, Walsh MN, Adler E, Ruo B, Stehlik J, Kirklin JK, Bedjeti K, Cella D, Hahn EA. Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study. J Heart Lung Transplant. 2024 Jan;43(1):36-50. doi: 10.1016/j.healun.2023.08.007. Epub 2023 Aug 15.'}, {'pmid': '36752104', 'type': 'DERIVED', 'citation': 'Hahn EA, Walsh MN, Allen LA, Lee CS, Denfeld QE, Teuteberg JJ, Beiser DG, McIlvennan CK, Lindenfeld J, Klein L, Adler ED, Stehlik J, Ruo B, Bedjeti K, Cummings PD, Vela AM, Grady KL. Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care. Circ Cardiovasc Qual Outcomes. 2023 Feb;16(2):e008690. doi: 10.1161/CIRCOUTCOMES.121.008690. Epub 2023 Feb 8.'}, {'pmid': '35258804', 'type': 'DERIVED', 'citation': 'Carroll AJ, Hahn EA, Grady KL. Research engagement and experiences of patients pre- and post-implant of a left ventricular assist device from the mechanical circulatory support measures of adjustment and quality of life (MCS A-QOL) study. Qual Life Res. 2022 Aug;31(8):2457-2470. doi: 10.1007/s11136-022-03111-4. Epub 2022 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device \\[VAD\\]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. This investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).', 'detailedDescription': 'It is estimated that 5.1 million U.S. adults have heart failure, with an incidence of 825,000 new cases annually. The prevalence of heart failure is expected to increase by 46% from 2012 to 2030. Mechanical circulatory support (MCS) has been developed as a bridge to heart transplantation and as permanent support (i.e., destination therapy). MCS devices help the heart pump blood to the body. Left ventricular assist devices (LVADs), a type of MCS, support the left heart.\n\nHealth-related quality of life (HRQOL) is a very important outcome that advanced heart failure patients care about when making health care decisions, including when considering surgical treatment options, such as heart transplantation and mechanical circulatory support.\n\nCurrently available HRQOL questionnaires do not assess the unique burdens of MCS, such as changing power sources and driveline exit site dressings; safety precautions (e.g., no immersion in water, need for an MCS-trained caregiver); troubleshooting VAD alarms; and MCS-specific complications, often associated with frequent hospitalizations. Since these questionnaires do not focus on issues of concern to MCS patients, they lack sensitivity and precision to measure the potentially wide-ranging impact of MCS on HRQOL.\n\nGuided by the investigators empirically supported MCS A-QOL conceptual model, the investigators will use state-of-the-science psychometric measurement methods to create "item banks" (sets of items that comprise carefully calibrated questions which define and quantify a common theme) from the investigators existing MCS A-QOL item pools (library of relevant items). Using calibrated item banks, the investigators will develop computer adaptive tests (CATs) and fixed-length short forms to reduce respondent burden and enhance measurement precision. The investigators will assess reliability, validity, responsiveness to change, and clinically important differences of MCS A-QOL measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is enrolling patients with advanced heart failure who require Mechanical Circulatory Support (MCS) to help the heart pump blood.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Group 1 Inclusion Criteria\n\n1. Advanced heart failure patients accepted for, or scheduled for, primary (first time) implant of a continuous flow MCS device left (L)VAD\n2. The continuous flow MCS device implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery\n3. Age \\>= 19 years and able to speak and understand English\n4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance.\n5. Willing to participate and able to give written informed consent\n\nGroup 1 Exclusion Criteria:\n\n1\\. Scheduled for implant of a bi-VAD, right (R)VAD, or total artificial heart\n\nGroup 2 Inclusion Criteria:\n\n1. Patient with a continuous flow MCS device left (L)VAD who is more than 3 months post-implant at the following intervals: 3, 6, 12, 18, 24, 30, 36, 42, 48 months and every 6 months thereafter. Note: patients can have had prior MCS devices.\n2. The continuous flow MCS device, implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery\n3. Age \\>= 19 years and able to speak and understand English\n4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance\n5. Willing to participate and able to give written informed consent\n\nGroup 2 Exclusion Criteria:\n\n1\\. Has a bi-VAD, right (R)VAD, or total artificial heart'}, 'identificationModule': {'nctId': 'NCT03044535', 'acronym': 'MCS A-QOL', 'briefTitle': 'Mechanical Support Measures of Adjustment and QOL', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Mechanical Circulatory Support: Measures of Adjustment and Quality of Life', 'orgStudyIdInfo': {'id': 'STU00201984'}, 'secondaryIdInfos': [{'id': '1R01HL130502-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL130502-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: Longitudinal assessment', 'description': 'Assessments will be performed pre-MCS, 3 months post-MCS and 6 months post-MCS. Participants in this group must be scheduled for MCS implant.'}, {'label': 'Group 2: Cross-sectional assessment', 'description': 'A one-time assessment will be performed on participants who are post-MCS implant (between 3 months and 10 years post-implant). Participants in this group must already have an MCS device in place.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80208', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Integris Health', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Kathleen L Grady, RN, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}, {'name': 'Elizabeth A Hahn, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'All published resources generated during the course of this work will be made available to other investigators upon request. Per study procedure, the investigators will respond to requests from other researchers to use de-identified data and make MCS A-QOL measurement system available to both researchers and clinicians for use.\n\nData that were derived from the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) will only be shared per data sharing protocols.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery and Medicine, Feinberg School of Medicine at Northwestern University', 'investigatorFullName': 'Kathleen Grady', 'investigatorAffiliation': 'Northwestern University'}}}}