N/A
Completed N=72
Promoting Patient-Centered Care Through a Heart Failure Simulation Study
Source: ClinicalTrials.gov NCT01917188 ↗Enrolled (actual)
72
Serious AEs
2.8%
Results posted
Jan 2019
Primary outcomePrimary: Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results — -4.69; -26.59; -29.36; -4.31 score on a scale
Summary
The initial aim of this study will be to assess current methods of heart failure (HF) patient education in terms of patient satisfaction, level of preparedness for home, and care provider satisfaction. The second aim will be to design and create a "living with HF at home" simulation session. The third aim will test the hypothesis that hospitalized HF patients who receive education in a simulation room in addition to usual HF education will have improved qualitative and quantitative outcomes as compared to those who do not receive the additional education support.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results |
-4.69; -26.59; -29.36; -4.31; -13.24; -15.09 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female > 18 years of age.
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- Documentation of HF of any etiology based on clinical assessment of the Primary Investigator, using standard-of-care criteria for diagnosis.
- Heart failure of either preserved or reduced ventricular function.
Exclusion Criteria
- Patients requiring ICU monitoring
- LVAD candidate/recipient
- Cardiac transplant candidate/recipient
- Confusion
- Sepsis
- Terminal illness (other than HF) with expected survival of less than 1 year
- Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
- Inability to comply with planned study procedures
- Active illicit drug use
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- Other conditions that in the opinion of the Primary Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
Data sourced from ClinicalTrials.gov (NCT01917188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.