Heart Failure
Conditions
Brief 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.
Interventions
BEHAVIORALFull simulation and education
BEHAVIORALSee simulation room, usual education
Sponsors
Intermountain Research and Medical Foundation
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female \> 18 years of age. 2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. 3. Documentation of HF of any etiology based on clinical assessment of the Primary Investigator, using standard-of-care criteria for diagnosis. 4. Heart failure of either preserved or reduced ventricular function.
Exclusion criteria
1. Patients requiring ICU monitoring 2. LVAD candidate/recipient 3. Cardiac transplant candidate/recipient 4. Confusion 5. Sepsis 6. Terminal illness (other than HF) with expected survival of less than 1 year 7. Enrollment or planned enrollment in another randomized clinical trial during this hospitalization 8. Inability to comply with planned study procedures 9. Active illicit drug use 10. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study. 11. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | 30 days | The mean differences in heart failure knowledge (from study enrollment to the 30 day study follow up) in each of the arms as assessed by the MLHFQ. Lower scores indicate improvement and a better health-related quality of life (HRQoL). The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full Simulation and Education Patients who will receive full simulation and education session prior to discharge.
Full simulation and education | 17 |
| See Simulation Room, Usual Education Patients will be shown the simulation room prior to discharge but will only receive usual education.
See simulation room, usual education | 17 |
| Usual Care Patients will receive usual care by bedside nurse. | 11 |
| Total | 45 |
Baseline characteristics
| Characteristic | Full Simulation and Education | See Simulation Room, Usual Education | Usual Care | Total |
|---|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 13 | 67.9 years STANDARD_DEVIATION 8.2 | 62.7 years STANDARD_DEVIATION 11.6 | 65.3 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 8 Participants | 2 Participants | 1 Participants | 11 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 10 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 29 | 1 / 23 | 1 / 20 |
| other Total, other adverse events | 1 / 29 | 0 / 23 | 1 / 20 |
| serious Total, serious adverse events | 0 / 29 | 1 / 23 | 1 / 20 |
Outcome results
Primary
Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results
The mean differences in heart failure knowledge (from study enrollment to the 30 day study follow up) in each of the arms as assessed by the MLHFQ. Lower scores indicate improvement and a better health-related quality of life (HRQoL). The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score.
Time frame: 30 days
Population: Only a small number of people completed and returned the quiz.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Simulation and Education | Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | Physical Score Difference | -4.31 score on a scale | Standard Deviation 15.25 |
| Full Simulation and Education | Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | Total Score Difference | -4.69 score on a scale | Standard Deviation 35.06 |
| Full Simulation and Education | Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | Emotional Score Difference | -0.88 score on a scale | Standard Deviation 8.6 |
| See Simulation Room, Usual Education | Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | Physical Score Difference | -13.24 score on a scale | Standard Deviation 11.51 |
| See Simulation Room, Usual Education | Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | Total Score Difference | -26.59 score on a scale | Standard Deviation 28.25 |
| See Simulation Room, Usual Education | Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | Emotional Score Difference | -6.59 score on a scale | Standard Deviation 8.28 |
| Usual Care | Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | Total Score Difference | -29.36 score on a scale | Standard Deviation 35.69 |
| Usual Care | Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | Emotional Score Difference | -5.27 score on a scale | Standard Deviation 8.88 |
| Usual Care | Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | Physical Score Difference | -15.09 score on a scale | Standard Deviation 14.58 |