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OpenTrials
Completed

NCT Number: NCT04444453

Early Ambulation to Reduce Hospital Length of Stay

Early ambulation of inpatients has been shown to be a key driver of decreased LOS and also reduced adverse events such as venous thromboembolism (VTE). We will test if a patient wearable device (pedometer) measuring steps and ambulation sessions decreases hospital LOS (primary outcome), decreases hospital LOS index (LOSI), decreases time to first ambulation, decreases time to first bowel movement (BM), decreases incidence of VTEs, and decreases costs (secondary outcomes). In a pilot randomized control trial, we will randomize 150 total adult patients admitted to UF Health Jacksonville in a 1:1 fashion to usual care and wearable pedometer or usual care. Patients randomized to the study intervention will receive a wearable pedometer upon admission, to be worn for the duration of their inpatient stay. Study outcome measures to be compared between the pedometer and no pedometer group include hospital LOS (primary outcome), hospital LOSI, time to first ambulation, time to first BM, incidence of VTEs, patient experience, and costs (secondary outcomes).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Jacksonville, Florida, 32209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ages > or equal to 18 years
  • Patient has capacity to undergo informed consent
  • Admitted to UF Health Jacksonville 8N progressive inpatient unit
  • Inpatient physician orders for patient ambulation and/or activity as tolerated upon hospital admission
  • Patient with a Fall Predictive Analytics score category of "low risk"
  • Patient with a Morse Fall Scale (MFS) of < or equal to 50
  • No contraindications to wearing a wrist pedometer (no skin breakdown, overlying skin infections, contact dermatitis, or indwelling catheters/need for venipuncture at wrist site)

Exclusion criteria

  • Patient < 18 years of age
  • Patient without capacity to undergo informed consent
  • Patient with a 'do not ambulate' order or has order for bed rest or other contraindication to ambulation (i.e., fall risk) or dependent on more than minimal assistance to ambulate
  • Patient with a Fall Predictive Analytics score category of "high risk"
  • Patient with MFS > 50 or labelled by clinical team as fall risk
  • Non-English speaking
  • In law enforcement custody or ward of the state
  • Pregnancy

Treatment and study plan

Wearable Pedometer

Device

Pedometer worn on wrist

Other names: Pedometer

Primary outcomes

  1. Hospital Length of Stay

    Time frame: Up to 1 month

    Time patient is admitted in hospital

Secondary outcomes

  1. Hospital length-of-stay index

    Time frame: Up to 1 month

  2. Time to first ambulation

    Time frame: Up to 1 month

  3. Time to first bowel movement

    Time frame: Up to 1 month

  4. Rate of venous thromboembolism

    Time frame: Up to 1 month

  5. Total hospitalization costs

    Time frame: Up to 1 month

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: EARLY

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2020
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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