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Trial record 33 of 137 for:    heart OR vascular OR aortic OR ventricular | Recruiting Studies | university of colorado

Mechanical Support Measures of Adjustment and QOL (MCS A-QOL)

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ClinicalTrials.gov Identifier: NCT03044535
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kathleen Grady, Northwestern University

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
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.

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
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Prospective
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/Cohort
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.
Group 3: Post-MCS
MCS patients who are 3 months post-MCS implant who have a smartphone will be asked to download the mobile CAT app and complete MCS A-QOL CAT measures at approximately 3, 4, and 5 months after implant.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study is enrolling patients with advanced heart failure who require Mechanical Circulatory Support (MCS) to help the heart pump blood.
Criteria

Group 1 Inclusion Criteria

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

Group 1 Exclusion Criteria:

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

Group 2 Inclusion Criteria:

  1. 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.
  2. The continuous flow MCS device, implant strategy can be a bridge to transplant, destination therapy, or bridge to recovery
  3. Age >= 19 years and able to speak and understand English
  4. Sufficient cognitive ability to provide self-report data on a computer touchscreen/standard computer and/or on paper-based forms with minimal assistance
  5. Willing to participate and able to give written informed consent

Group 2 Exclusion Criteria:

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

Group 3 Inclusion Criteria:

  1. Approximately 3 months post-primary (first time) implant of a continuous flow MCS device
  2. Left ventricular assist device (LVAD), with an implant strategy of bridge to transplant, destination therapy, or bridge to recovery
  3. Age >= 19 years and able to speak and understand English
  4. Has a smartphone
  5. Willing to participate and able to give written informed consent

Group 3 Exclusion Criteria:

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


Information from the National Library of Medicine

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


Contacts
Contact: Kathleen L Grady, RN, PhD (312) 695-4860 kgrady@nm.org
Contact: Elizabeth A Hahn, MA (312) 503-9804 e-hahn@northwestern.edu

Locations
United States, California
University of California Recruiting
San Francisco, California, United States, 94117
Contact: Liviu Klein, MD    415-476-2143    Liviu.Klein@ucsf.edu   
Contact: Cynthia Partida       Cynthia.Partida@ucsf.edu   
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Dipanjan Banerjee, MD, MS    650-533-2433    dipanjan@stanford.edu   
Contact: Reem Yunis, PhD    650.279.7769    ryunis@standford.edu   
Sub-Investigator: Julie A Shinn, RN, MS         
United States, Colorado
University of Colorado Recruiting
Denver, Colorado, United States, 80208
Contact: Larry A Allen, MD    303-596-5724    Larry.Allen@ucdenver.edu   
Contact: Pilar Ingle    303-724-8754    Pilar.Ingle@ucdenver.edu   
Sub-Investigator: Colleen McIlvennan, DNP, MS, BSN         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Sarah Buono    312-503-3445    sarah-buono@northwestern.edu   
Contact: Mohammed Nooruddin    312-695-1806    mohammed.nooruddin@nm.org   
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: David G Beiser, MD    773-702-0307    dbeiser@medicine.bsd.uchicago.edu   
Contact: Jenifer Goldberg    312.702.5424    jgoldberg1@medicine.bsd.uchicago.edu   
Sub-Investigator: Catherine Murks, PhD, RN         
United States, Indiana
St. Vincent Hospital Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Mary N Walsh, MD    317-338-6666    macwalsh@iquest.net   
Contact: Katie Johnson    317-338-5329    Katharine.Johnson@theheartcenter.com   
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Michael Kiernan, MD    617-636-2538    mkiernan@tuftsmedicalcenter.org   
Contact: Nathan Yuen    617-636-4990    nyuen@tuftsmedicalcenter.org   
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Christopher Lee, PhD, RN    503-494-4410    leechri@ohsu.edu   
Contact: Shirin O Hiatt    503-494-3978    hiatts@ohsu.edu   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37240
Contact: JoAnn Lindenfeld, MD    615-936-8187    joann.lindenfeld@vanderbilt.edu   
Contact: Stephanie Stoops    615-936-5463    stephanie.stoops@vanderbilt.edu   
Sub-Investigator: Brian Widmar, PhD, RN         
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

Responsible Party: Kathleen Grady, Professor of Surgery and Medicine, Feinberg School of Medicine at Northwestern University, Northwestern University
ClinicalTrials.gov Identifier: NCT03044535     History of Changes
Other Study ID Numbers: STU00201984
1R01HL130502-01 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.

Data that were derived from the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) will only be shared per data sharing protocols.


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathleen Grady, Northwestern University:
quality of life
mechanical circulatory support

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases