A Study to Assess Emotional Experiences in Patients with Symptomatic Heart Failure and Left Ventricular Assist Devices
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: 20-011392
About this study
The objectives of this study are to use qualitative methods to characterize patients’ distress, to use qualitative methods to explore how distress can impact healthcare behaviors and caregiver support; specifically, their motivation to sustain critical lifestyle changes and provide assertive communication with caregivers and medical teams, and to use qualitative methodology to explore if themes found in patients with symptomatic heart failure (HF) translate to patients with left ventricular assist devices (LVAD) or if they will be superseded by LVAD-specific themes.
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- Aim 1 and Aim 2:
- Adults older than 18 years.
- Any gender/race/ethnicity, diagnosed with heart failure (HF) at any time and New York Heart Association (NYHA) II-IV, who are being followed-up at the Mayo Clinic Heart Failure Clinic.
- Who are able to attend outpatient follow-up in person or virtually.
- Willing and able to provide informed consent.
- Speak English.
Exclusion Criteria - Aim 1 and Aim 2:
- Patients who do not read, write, or speak English or who cannot verbally communicate.
- Patients with active substance abuse, diagnosis of dementia, traumatic brain injury, stroke with residual symptoms, acute psychosis, or mania.
Inclusion Criteria - Aim 3:
- Adults older than 18 years.
- Any gender/race/ethnicity.
- Have received an left ventricular assist devices (LVAD) as destination therapy.
- Able to attend outpatient follow-up in person or virtually.
- Willing and able to provide informed consent.
- Speak English.
Exclusion Criteria - Aim 3:
- Patients who have had an LVAD in the past but has been removed.
- Patients with LVAD as bridge to transplant.
- Patients who do not read, write, or speak English and who cannot verbally communicate.
- Patients with active substance abuse.
- Diagnosis of dementia.
- Traumatic brain injury.
- Stroke with residual symptoms.
- Acute psychosis or mania.
Eligibility last updated 11/1/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jeffrey Staab, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available