AmbulationEARLYNCT04444453
Early Ambulation to Reduce Hospital Length of Stay
A study testing Wearable Pedometer in people with Ambulation and Wearable Devices, run by University of Florida at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ambulation, Wearable Devices
- What is being tested?
- Wearable Pedometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Ambulation, Wearable Devices
- Being tested
- Wearable Pedometer
- Keywords
- length of stay, hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable PedometerDevice
Also called Pedometer
Pedometer worn on wrist
| Study group | Role | What they receive |
|---|---|---|
| Pedometer | Experimental | Admitted patients who receive a pedometer to wear during their hospital stay to measure steps ambulated Receives: Device: Wearable Pedometer |
| Control | No intervention | Patients admitted to hospital who do not receive a pedometer, but receive all other usual standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Time patient is admitted in hospital
Measured: Up to 1 month
Secondary outcomes (5)
Hospital length-of-stay index
Measured: Up to 1 month
Time to first ambulation
Measured: Up to 1 month
Time to first bowel movement
Measured: Up to 1 month
Rate of venous thromboembolism
Measured: Up to 1 month
Total hospitalization costs
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start21 Oct 2020
- Primary completion1 Aug 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmbulationStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Fishe, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444453
- Sponsor's protocol ID
- IRB202001410
- Other IDs
- IRB202001410
- Acronym
- EARLY
- Status last verified
- Jan 2023
- First submitted
- 18 Jun 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Ambulation to Reduce Hospital Length of Stay
- ClinicalTrials.gov ID
- NCT04444453
- Acronym / sponsor ID
- EARLY / IRB202001410
- Conditions
- Ambulation, Wearable Devices
- Keywords
- length of stay, hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedometer | Experimental | Device: Wearable PedometerAdmitted patients who receive a pedometer to wear during their hospital stay to measure steps ambulated |
| Control | No intervention | –Patients admitted to hospital who do not receive a pedometer, but receive all other usual standard of care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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"
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable PedometerAlso: PedometerPedometer worn on wrist | Device | Pedometer |
Primary outcome
Hospital Length of Stay
Time frame: Up to 1 month
Time patient is admitted in hospital
5 secondary outcomes
Hospital length-of-stay index
Time frame: Up to 1 month
Time to first ambulation
Time frame: Up to 1 month
Time to first bowel movement
Time frame: Up to 1 month
Rate of venous thromboembolism
Time frame: Up to 1 month
Total hospitalization costs
Time frame: Up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Fishe, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Pedometer in people with Ambulation and Wearable Devices, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Length of Stay (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.