An interventional study of Full simulation and education and See simulation room, usual education in Heart Failure, sponsored by Intermountain Health Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Intermountain Health Care, Inc. · Not applicable, Interventional, and Supportive care
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 72 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who will receive full simulation and education session prior to discharge.
Behavioral: Full simulation and education
Patients will be shown the simulation room prior to discharge but will only receive usual education.
Behavioral: See simulation room, usual education
Patients will receive usual care by bedside nurse.
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
| Milestone | Full Simulation and Education | See Simulation Room, Usual Education | Usual Care |
|---|---|---|---|
| Started | 29 | 23 | 20 |
| Completed | 17 | 17 | 11 |
| Not completed | 12 | 6 | 9 |
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.
| score on a scale | Full Simulation and Education | See Simulation Room, Usual Education | Usual Care |
|---|---|---|---|
| Total Score Difference | -4.69 ± 35.06 | -26.59 ± 28.25 | -29.36 ± 35.69 |
| Physical Score Difference | -4.31 ± 15.25 | -13.24 ± 11.51 | -15.09 ± 14.58 |
| Emotional Score Difference | -0.88 ± 8.60 | -6.59 ± 8.28 | -5.27 ± 8.88 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Full Simulation and Education | 2/29 (6.9%) | 0/29 (0%) | 1/29 (3.4%) |
| See Simulation Room, Usual Education | 1/23 (4.3%) | 1/23 (4.3%) | 0/23 (0%) |
| Usual Care | 1/20 (5%) | 1/20 (5%) | 1/20 (5%) |
| Event | Full Simulation and Education | See Simulation Room, Usual Education | Usual Care |
|---|---|---|---|
| Subarachnoid hemorrhage after a fallNervous system disorders | 0/29 | 0/23 | 1/20 |
| Knee wound dehiscenceSkin and subcutaneous tissue disorders | 0/29 | 1/23 | 0/20 |
| Event | Full Simulation and Education | See Simulation Room, Usual Education | Usual Care |
|---|---|---|---|
| hypertensionVascular disorders | 0/29 | 0/23 | 1/20 |
| lightheadedCardiac disorders | 1/29 | 0/23 | 0/20 |
Only included those who completed the study.
| Age, Continuous(years) | Full Simulation and Education | See Simulation Room, Usual Education | Usual Care | Total |
|---|---|---|---|---|
| Mean | 66 ± 13 | 67.9 ± 8.2 | 62.7 ± 11.6 | 65.3 ± 11.1 |
| Sex: Female, Male(Participants) | Full Simulation and Education | See Simulation Room, Usual Education | Usual Care | Total |
|---|---|---|---|---|
| Female | 8 | 2 | 1 | 11 |
| Male | 9 | 15 | 10 | 34 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Intermountain Health Care, Inc.