CHF Inpatient Ambulation Trial

NCT ID: NCT02828553

Last Updated: 2019-08-30

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

Total Enrollment

352 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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There is an overwhelming amount of deconditioning that occurs during the hospitalization to a patient admitted with a primary diagnosis of congestive heart failure. The goals of this study are to determine if monitored activity and aggressive mobility provides improved outcomes in hospitalized heart failure patients.

Detailed Description

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By implementing an ambulatory study, the goal is to decrease the hospital length of stay by half of a day, decrease the percentage of patients being discharged to an extended nursing care facility, and improve quality of life for the patient. Fiscal year 2014 the average length of stay for a CHF patient at Lancaster General Health was 6.0, and as of fiscal year 2015 this was decreased to 5.8. According to Harlan M Krumbholz's theory of post hospital syndrome, patients are subjected to a time of increased risk of impaired stamina, coordination, strength and readmission for about thirty days after discharge due to deconditioning during their hospitalization. By implementing the ambulatory study, the hope is to prevent such extensive deconditioning to help improve the patient's quality of life after discharge; thereby reducing length of stay, discharges to skilled nursing facilities, 30 day readmissions and costs.

The advent of wearable activity and/or health monitors in the health and fitness industry segment has the potential to revolutionize the industry. More importantly, these devices allow new variables to be collected to provide an impact on patients' care and outcome such as steps taken per day.

The intention of the ambulation study is to prevent hospital acquired deconditioning; which in turn would not only decrease the length of stay, but also improve the discharge disposition and place them at home rather than hospice, an extended care facility or rehab. Not only is the intent of the study to decrease the length of stay and also improve the patient's disposition, but also improve their quality of life. In addition, the study will test the effectiveness of the addition of a mobility aide to assist with patients walking on the nursing units.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group - Usual Care

At the start of the study, subjects will be enrolled in usual care when admitted to the heart failure unit following standard protocols.

No interventions assigned to this group

Intervention Group - Aggressive Ambulation

After a washout period and transition to a new aggressive ambulation protocol, subjects will be enrolled to usual care + aggressive planned ambulation with a trained mobility aide.

Aggressive planned ambulation with a mobility aide

Intervention Type OTHER

A trained mobility aide will provide aggressive ambulation at least 3X per day for all patients on the heart failure unit

Interventions

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Aggressive planned ambulation with a mobility aide

A trained mobility aide will provide aggressive ambulation at least 3X per day for all patients on the heart failure unit

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of heart failure
* The heart group as attending or consultant
* Patient on 5 West at the time of admission
* Admission diagnosis of heart failure
* Age ≥ 18
* Initial assessment completed within 10 hours of admission by a registered nurse

Exclusion Criteria

* Patient admitted from acute rehabilitation or skilled nursing facility
* Altered weight bearing or unable to complete initial 2 minute walk test
* Unwilling or unable to participate or consent
* Acute delirium or dementia by history
* Hospice or actively dying
* Ventricular assist device or listed for heart transplantation
* Inotrope dependence
* Active ischemia
* Heart rate (HR) \<50 or \>130 at rest
* Blood pressure (BP) \<80 or \>180 at rest
* Pulse oximetry \<88% at rest
* Patient is in isolation for multi-drug resistant organism such as MRSA or C-diff
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lancaster General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Roberts, DO

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Lisa Rathman, CRNP

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Dana Irwin, BSN, RN

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Michael Killinger, MSN, RN

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Nathaniel Baker, DPT

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Michael Horst, PhD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Locations

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Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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CHF Inpatient Ambulation Trial

Identifier Type: -

Identifier Source: org_study_id

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