Completed

Heart Failure Disease Management Program in Skilled Nursing Facilities for Reduced Rehospitalizations and Mortality

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Study Aim

This study aims to determine if a heart failure disease management program can reduce hospitalizations, emergency department visits, and mortality within 60 days for heart failure patients in skilled nursing facilities, compared to usual care.

What is being tested

Heart Failure Disease Management Program

+ Heart Failure Usual Care

Other
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Last updated: August 7, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

Heart failure patients who are discharged to skilled nursing facilities face higher risks of rehospitalization and mortality compared to those who return home. Currently, there are no national guidelines for heart failure disease management programs in skilled nursing facilities, despite evidence that such programs can reduce rehospitalizations in community settings. This study aims to evaluate the impact of a heart failure disease management program on patients' outcomes within 30 days post-admission to a skilled nursing facility, with a focus on preventing rehospitalizations, emergency room visits, and mortality. Patients participating in this study will be cared for either through a specialized heart failure disease management program or usual care. The program consists of seven components designed to manage heart failure effectively. The study's primary outcome is to measure the difference in the composite endpoint of 60-day all-cause hospitalization, all-cause emergency department visits, and all-cause mortality between patients in skilled nursing facilities who receive care via the disease management program versus usual care.

NCT01822912
Principal SponsorUniversity of Colorado, Denver
Last updated: August 7, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

713 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

2 inclusion criteria required to participate
Heart Failure is listed as the hospital discharge primary diagnosis

Heart Failure is listed as the hospital discharge secondary diagnosis

1 exclusion criteria prevent from participating
Any life threatening condition which predicts mortality in 6 months or less

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Patients will receive personalized care to include medication titration, daily weights, symptom and activity assessment, documentation of ejection fraction, patient and caregiver education,dietary surveillance, discharge instructions and follow up visit within 7 days of SNF discharge

Group II

Placebo
SNF patients with HF will receive usual care

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Colorado

Aurora, United StatesOpen University of Colorado in Google Maps
CompletedOne Study Center