Patient-Reported Outcomes as an Indicator of Disease Transitions in Heart Failure
- Conditions
- Heart Failure
- Registration Number
- NCT04264845
- Lead Sponsor
- Intermountain Health Care, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 3640
Inclusion Criteria:<br><br>Eligible participants in the Provider Focus Group and Patient Interview Group:<br><br> 1. Male or female > 18 years of age<br><br> 2. Ability to understand and provide agreement to participation, which must be obtained<br> prior to initiation of any study procedures<br><br> 3. Willing and able to comply with the protocol requirements and schedule of<br> evaluations<br><br>The Provider Focus Group must meet the following additional criteria:<br><br> 1. Heart failure providers, including cardiologists, cardiothoracic surgeons, physician<br> assistants, nurse practitioners, nurses, and medical assistants.<br><br> 2. They are members of the University of Utah and/or Intermountain Medical Center Heart<br> Failure Teams.<br><br>The Patient Interview Group must meet the following additional criteria:<br><br> 1. Documentation of heart failure with reduced ejection fraction (<50%) or heart<br> failure with preserved ejection fraction (>50%)<br><br> 2. The patient is followed in heart failure clinic at Intermountain Medical Center or<br> the University of Utah<br><br> 3. Ability to complete PROs, including the KCCQ12 and PROMIS<br><br> 4. Ability to complete a telephone interview<br><br>The PROs/Clinical Data Integration Group must meet the following criteria:<br><br> 1. Male or female > 18 years of age<br><br> 2. Documentation of heart failure with reduced ejection fraction (<50%) or heart<br> failure with preserved ejection fraction (>50%)<br><br> 3. The patient is followed in heart failure clinic at Intermountain Medical Center or<br> the University of Utah<br><br> 4. No other inclusion criteria are required for this group because study-required<br> information will be obtained from electronic medical records and will not require<br> direct patient contact.<br><br>A subset of subjects in this third group (PROs/Clinical Data Integration Group) will be<br>invited to provide a blood sample for the purpose of examining the biological<br>determinants of patient health status in HF, provided they meet the following criteria:<br><br> - Age > 18<br><br> - Documentation of heart failure with reduced ejection fraction (<50%) or heart<br> failure with preserved ejection fraction (>50%)<br><br> - The patient is followed in heart failure clinic at Intermountain Medical Center or<br> the University of Utah<br><br> - The patient has no contraindications for blood draws<br><br>Exclusion Criteria:<br><br>Provider Focus Group:<br><br> 1. The provider is not interested or is unable to participate in the focus group<br><br> 2. The Principal Investigator determines that the provider is not eligible for this<br> research study<br><br>Patient Interview Group:<br><br> 1. The patient is not willing to be interviewed<br><br> 2. Participation in any other clinical trials involving investigational or marketed<br> products within 30 days prior to entry in the study<br><br> 3. Other conditions that in the opinion of the Principal Investigator may increase risk<br> to the subject and/or compromise the quality of the clinical trial<br><br> 4. The Principal Investigator determines that the proposed patient is not eligible for<br> this research study<br><br>PROs/Clinical Data Integration Group:<br><br> 1. Participation in any other clinical trials involving investigational or marketed<br> products within 30 days prior to entry in the study<br><br> 2. Other conditions that in the opinion of the Principal Investigator may compromise<br> the quality of the clinical trial<br><br> 3. The Principal Investigator determines that the proposed patient is not eligible for<br> this research study<br><br>A subset of subjects in this third group (PROs/Clinical Data Integration Group) will be<br>invited to provide a blood sample for the purpose of examining the biological<br>determinants of patient health status in HF, except the following:<br><br> - Patients who are not interested in providing blood samples<br><br> - Patients without heart failure<br><br> - Patients with contraindications to blood draws
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time necessary for PRO completion by patients;Completion rate among eligible patients
- Secondary Outcome Measures
Name Time Method