Heart Failure Management Program Versus Usual Care

NCT ID: NCT01822912

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

713 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2019-03-31

Brief Summary

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Heart Failure (HF) patients discharged to Skilled Nursing Facilities have higher rehospitalization rates and mortality than patients discharged to home.

HF disease management programs have been shown to reduce rehospitalizations in community settings, no national guidelines have been set forth for Skilled Nursing Facilities (SNF).

This study will investigate the the effect of a heart failure-disease management program on the outcome of all-cause hospital readmissions, emergency room admissions and mortality for 30 days post-SNF admission using 7 component heart failure disease management program.

Detailed Description

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Conditions

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Cardiac Failure Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Heart Failure Disease Management Program

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 Type ACTIVE_COMPARATOR

Heart Failure Disease Management Program

Intervention Type OTHER

Subjects will be assessed 3 times a week while in SNF.

Heart Failure Usual Care

SNF patients with HF will receive usual care

Group Type PLACEBO_COMPARATOR

Heart Failure Usual Care

Intervention Type OTHER

Subjects will receive standard of care.

Interventions

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Heart Failure Disease Management Program

Subjects will be assessed 3 times a week while in SNF.

Intervention Type OTHER

Heart Failure Usual Care

Subjects will receive standard of care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Heart Failure is listed as the hospital discharge primary diagnosis
* Heart Failure is listed as the hospital discharge secondary diagnosis

Exclusion Criteria

* Any life threatening condition which predicts mortality in 6 months or less
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Boxer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Lum H, Obafemi O, Dukes J, Nowels M, Samon K, Boxer RS. Use of Medical Orders for Scope of Treatment for Heart Failure Patients During Postacute Care in Skilled Nursing Facilities. J Am Med Dir Assoc. 2017 Oct 1;18(10):885-890. doi: 10.1016/j.jamda.2017.05.021. Epub 2017 Jul 6.

Reference Type DERIVED
PMID: 28688730 (View on PubMed)

Other Identifiers

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R01HL113387

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-0006

Identifier Type: -

Identifier Source: org_study_id

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