Promoting Patient-Centered Care Through a Heart Failure Simulation Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Medical Center

Murray, Utah, 84107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full simulation and education

Behavioral

See simulation room, usual education

Behavioral

Primary outcomes

Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

Intermountain Research and Medical Foundation

Registry information

Acronym: HF SIM

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Aug 6, 2013
Registry last updated: Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed