Back to resultsPromoting Patient-Centered Care Through a Heart Failure Simulation Study (HF SIM)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full simulation and education
See simulation room, usual education
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
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.
Sites / Locations
- Intermountain Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Other
No Intervention
Arm Label
Full simulation and education
See simulation room, usual education
Usual care
Arm Description
Patients who will receive full simulation and education session prior to discharge.
Patients will be shown the simulation room prior to discharge but will only receive usual education.
Patients will receive usual care by bedside nurse.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01917188
First Posted
August 1, 2013
Last Updated
July 25, 2018
Sponsor
Intermountain Health Care, Inc.
Collaborators
Intermountain Research and Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01917188
Brief Title
Promoting Patient-Centered Care Through a Heart Failure Simulation Study
Acronym
HF SIM
Official Title
Promoting Patient-Centered Care Through a Heart Failure Simulation Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
Intermountain Research and Medical Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full simulation and education
Arm Type
Active Comparator
Arm Description
Patients who will receive full simulation and education session prior to discharge.
Arm Title
See simulation room, usual education
Arm Type
Other
Arm Description
Patients will be shown the simulation room prior to discharge but will only receive usual education.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients will receive usual care by bedside nurse.
Intervention Type
Behavioral
Intervention Name(s)
Full simulation and education
Intervention Type
Behavioral
Intervention Name(s)
See simulation room, usual education
Primary Outcome Measure Information:
Title
Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kismet D Rasmusson, FNP-BC
Organizational Affiliation
Intermountain Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Promoting Patient-Centered Care Through a Heart Failure Simulation Study
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