A Study to Evaluate if Modifications to the Kansas City Cardiomyopathy Questionnaire Are Needed to Address Interpretation Differences by Gender
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-012802
Sponsor Protocol Number: 19-012802
About this study
The purpose of this study is to describe if and how men and women interpret Kansas City Cardiomyopathy Questionnaire (KCCQ) questions differently using qualitative interviews.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 22 years old.
- A clinician-diagnosed NYHA I-IV heart failure.
- LVEF ≤ 40% on most recent cardiac imaging.
- Ability to read, speak and understand English.
- Access to a telephone for interviews or ability to meet study staff in person for an interview.
- Ability and willingness to participate in all study related activities.
- Provide informed written or verbal consent based on site IRB requirements.
Exclusion Criteria:
- Clinically significant cognitive or memory impairment in the opinion of research staff (e.g., patient has trouble holding a conversation, patient exhibits signs of disorientation).
- Currently hospitalized.
- Individuals who have left ventricular assist device (LVAD) or are planning to have surgery to implant an LVAD within 2 weeks of screening.
- Individuals who have received a cardiac transplant at any time prior to screening.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available