Clinical trial NCT02828553: CHF Inpatient Ambulation Trial
Official title: CHF Inpatient Ambulation Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Wearable device
Fitbit
Inpatient
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Walk distance
timeFrame: Through study completion, an average of 5 days
measure: Steps per day
timeFrame: Through study completion, an average of 5 days
Secondary outcomes:
measure: Disposition at Discharge
timeFrame: At discharge/completion of study; an average of 5 days after admission
measure: Readmission within 30 days
timeFrame: 30 Days after discharge
measure: Falls
timeFrame: Through study completion, an average of 5 days
measure: Length of Stay
timeFrame: Through study completion, an average of 5 days
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
Study officials:
affiliation: Lancaster General Hospital
name: Justin Roberts, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Lisa Rathman, CRNP
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Dana Irwin, BSN, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Michael Killinger, MSN, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Nathaniel Baker, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Michael Horst, PhD
role: PRINCIPAL_INVESTIGATOR
References: