CHF Inpatient Ambulation Trial

NCT02828553 | Completed

• 1 other identifier: CHF Inpatient Ambulation Trial
• Study Type: observational
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Wearable device; Fitbit; Inpatient

Outcome Measures

Primary Outcomes (2)

• Walk distance

  Walk distance using a 2-minute walk test will be assessed at admission and again at discharge. A clear starting and stopping point will be made with distance marked every 10 feet. A chair with armrests will be at the starting and stopping point of the walk distance. The designated area will be between 5 East and 5 West which will be standard for each patient. After the assessment the nurse will document the total patient's distance to the nearest 10 feet. Example "Ms. Smith walked 100 feet with 3 stops in 2 minutes." The patient will have a repeat 2 minute walk test on the day of discharge using the same criteria. For the walk test: * Gait belt must be used * Patient will be allowed to stop, lean on the wall and rest, but if requires sitting, terminates the 2 minute walk distance. * IV medications on hold is able

  Through study completion, an average of 5 days

• Steps per day

  Steps per day for each day in the hospital will be measured in 15-minute intervals from admission to discharge using a Fitbit device (wearable device on the wrist). Data will be downloaded from the Fitbit upon discharge.

  Through study completion, an average of 5 days

Secondary Outcomes (4)

• Disposition at Discharge

  At discharge/completion of study; an average of 5 days after admission

• Readmission within 30 days

  30 Days after discharge

• Falls

  Through study completion, an average of 5 days

• Length of Stay

  Through study completion, an average of 5 days

Study Arms (2)

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.

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.

Other: Aggressive planned ambulation with a mobility aide

Interventions

Aggressive planned ambulation with a mobility aide OTHER

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

Intervention Group - Aggressive Ambulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients entering the Lancaster General Hospital heart failure unit (5 East or 5 West) will be evaluated with a 2 minute walk test and if able to complete this test will be offered the opportunity to enroll/consent for participation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lancaster General Hospital: lead

Study Sites (1)

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Justin Roberts, DO

  Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

• Lisa Rathman, CRNP

  Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

• Dana Irwin, BSN, RN

  Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

• Michael Killinger, MSN, RN

  Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

• Nathaniel Baker, DPT

  Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

• Michael Horst, PhD

  Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: July 11, 2016
• Study Start: October 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)