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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL130502-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
Health-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.
Currently 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.
Guided 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Longitudinal assessment | 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. | ||
| Group 2: Cross-sectional assessment | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Creation of new MCS A-QOL item banks and short forms and validation of existing instruments | 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. | Longitudinally: baseline through 6 months post-MCS implant and cross-sectionally through 10 years post-MCS implant |
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Group 1 Inclusion Criteria
Group 1 Exclusion Criteria:
1. Scheduled for implant of a bi-VAD, right (R)VAD, or total artificial heart
Group 2 Inclusion Criteria:
Group 2 Exclusion Criteria:
1. Has a bi-VAD, right (R)VAD, or total artificial heart
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This study is enrolling patients with advanced heart failure who require Mechanical Circulatory Support (MCS) to help the heart pump blood.
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen L Grady, RN, PhD | Northwestern University | Principal Investigator |
| Elizabeth A Hahn, MA | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037 | United States | ||
| University of California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40485994 | Derived | 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. | |
| 37591454 | Derived |
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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.
Data that were derived from the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) will only be shared per data sharing protocols.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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| San Francisco |
| California |
| 94117 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| University of Colorado | Denver | Colorado | 80208 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| St. Vincent Hospital | Indianapolis | Indiana | 46260 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Integris Health | Oklahoma City | Oklahoma | 73112 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Vanderbilt University | Nashville | Tennessee | 37240 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| 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. |
| 36752104 | Derived | 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. |
| 35258804 | Derived | 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. |