Mechanical Support Measures of Adjustment and QOL (MCS A-QOL)
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|ClinicalTrials.gov Identifier: NCT03044535|
Recruitment Status : Active, not recruiting
First Posted : February 7, 2017
Last Update Posted : March 6, 2020
|Condition or disease|
|Quality of Life Heart Failure Cardiovascular Diseases|
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.
The investigators will then explore ways to enhance patient care by using MCS A-QOL clinically. The investigators will develop and test a mobile CAT app to be used by patients and their health care providers. A printed computer-generated summary and interpretation of these measures will be shared with patients and their health care providers during clinic visits. They will also participate in semi-structured interviews to assess the user experience (i.e., understandability, usability, and acceptability) of the mobile app and printed reports.
|Study Type :||Observational|
|Actual Enrollment :||895 participants|
|Official Title:||Mechanical Circulatory Support: Measures of Adjustment and Quality of Life|
|Actual Study Start Date :||October 26, 2016|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||February 28, 2021|
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 4 years post-implant). Participants in this group must already have an MCS device in place.
- Creation of new MCS A-QOL item banks and short forms and validation of existing instruments [ Time Frame: Longitudinally: baseline through 6 months post-MCS implant and cross-sectionally up to 4 years post-MCS implant ]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.
- Enhancement of patient-centered care using MCS A-QOL in clinical practice [ Time Frame: 3 to 5 months after MCS implant ]MCS A-QOL assessments, using CAT, will be collected at 3, 4, and 5 months after MCS implant via a mobile app. Understandablity, acceptability, and usefulness of the mobile app will be determined through participation in semi-structured interviews by patients and healthcare providers, with the goal of enhancing patient-centered care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044535
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92037|
|University of California|
|San Francisco, California, United States, 94117|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|United States, Colorado|
|University of Colorado|
|Denver, Colorado, United States, 80208|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|St. Vincent Hospital|
|Indianapolis, Indiana, United States, 46260|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73112|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37240|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Kathleen L Grady, RN, PhD||Northwestern University|
|Principal Investigator:||Elizabeth A Hahn, MA||Northwestern University|