MCS A-QOL: Mechanical Support Measures of Adjustment and QOL

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT03044535

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

895

Enrollment

Locations

40.1

Actual Duration (Months)

74.6

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Quality of Life Heart Failure Cardiovascular Diseases

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

895 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Mechanical Circulatory Support: Measures of Adjustment and Quality of Life

Actual Study Start Date :

Oct 26, 2016

Actual Primary Completion Date :

Feb 28, 2020

Actual Study Completion Date :

Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Creation of new MCS A-QOL item banks and short forms and validation of existing instruments [Longitudinally: baseline through 6 months post-MCS implant and cross-sectionally through 10 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Group 1 Inclusion Criteria

Advanced heart failure patients accepted for, or scheduled for, primary (first time) implant of a continuous flow MCS device left (L)VAD
The continuous flow MCS device implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery
Age >= 19 years and able to speak and understand English
Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance.
Willing to participate and able to give written informed consent

Group 1 Exclusion Criteria:

Scheduled for implant of a bi-VAD, right (R)VAD, or total artificial heart

Group 2 Inclusion Criteria:

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.
The continuous flow MCS device, implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery
Age >= 19 years and able to speak and understand English
Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance
Willing to participate and able to give written informed consent

Group 2 Exclusion Criteria:

Has a bi-VAD, right (R)VAD, or total artificial heart

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	La Jolla	California	United States	92037
2	University of California	San Francisco	California	United States	94117
3	Stanford University Medical Center	Stanford	California	United States	94305
4	University of Colorado	Denver	Colorado	United States	80208
5	Northwestern University	Chicago	Illinois	United States	60611
6	University of Chicago	Chicago	Illinois	United States	60637
7	St. Vincent Hospital	Indianapolis	Indiana	United States	46260
8	Tufts Medical Center	Boston	Massachusetts	United States	02111
9	Integris Health	Oklahoma City	Oklahoma	United States	73112
10	Oregon Health and Science University	Portland	Oregon	United States	97239
11	Vanderbilt University	Nashville	Tennessee	United States	37240
12	University of Utah	Salt Lake City	Utah	United States	84132

Sponsors and Collaborators

Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Kathleen L Grady, RN, PhD, Northwestern University
Principal Investigator: Elizabeth A Hahn, MA, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kathleen Grady, Professor of Surgery and Medicine, Feinberg School of Medicine at Northwestern University, Northwestern University

ClinicalTrials.gov Identifier:

NCT03044535

Other Study ID Numbers:

STU00201984
1R01HL130502-01

First Posted:

Feb 7, 2017

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kathleen Grady, Professor of Surgery and Medicine, Feinberg School of Medicine at Northwestern University, Northwestern University

quality of life

mechanical circulatory support

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Feb 16, 2022