Postoperative CareNCT02833324
Fitbit for Postoperative Ambulation
A study testing Education regarding ambulation, Ambulation reminder alarms and Fitbit in people with Postoperative Care, run by Emory University at 1 site in United States.
Trial summary
This trial will investigate whether using reminder alarms with a wireless activity tracking device (Fitbit) will increase daily ambulation in individuals who have just had colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Care
- What is being tested?
- Education regarding ambulation, Ambulation reminder alarms and Fitbit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing an elective surgical procedure in colorectal services at Emory University Hospital
Who cannot join
- Post-surgical admission into the intensive care unit (ICU)
- Have an open abdomen due to surgical complications
- Wound Vacuum Assisted Closure (VAC) dependent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can a Fitbit (a Mobile Tracking Device) Increase Ambulation of Colorectal Surgical Patients in the Postoperative Period?
This trial will investigate whether using reminder alarms with a wireless activity tracking device (Fitbit) will increase daily ambulation in individuals who have just had colorectal surgery.
Read the detailed description
Early mobilization after surgery has been shown to reduce recovery time, incidence of venous thromboembolism, length of hospital stay and both pulmonary and general post-operative complications. Ambulation is also a main tenant of a fast-track recovery protocol known as Enhanced Recovery After Surgery (ERAS), which is commonly used among colorectal surgical practices and being implanted across other surgical practices. Despite evidence supporting its benefit, early ambulation has been identified as the one of the most difficult clinical interventions to enforce and to measure.
The primary objective of this trial is to investigate whether the use of wireless activity tracking device (Fitbit) with 5 daily reminder alarms will increase daily ambulation on postoperative day 0 until post operative day 9 or hospital discharge (whichever occurs first). Secondary objectives include evaluating the effect of Fitbit as a motivating factor on the frequency of postoperative ileus, time to return of bowel function, number of venous thromboembolism (VTE), pneumonia (PNA) and other pulmonary complications, number of code Medical Emergency Team (MET) alerts, and overall cost saving.
- Conditions
- Postoperative Care
- Being tested
- Education regarding ambulation, Ambulation reminder alarms, Fitbit
- Keywords
- Postoperative Period, Colorectal Surgery, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education regarding ambulationBehavioural
The participants will be educated on the importance of postoperative ambulation during the recovery period.
Ambulation reminder alarmsBehavioural
Participants in the intervention arm will receive 5 daily alarms to prompt them to ambulate. Alarms will be set to ring at 9am, 11am, 2pm, 5pm and 9pm. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.
FitbitOther
Participants who are postoperative for colorectal surgery, who have been cleared to ambulate during recover, will be equipped with an off-the-shelf Fitbit device (a wireless activity tracking device) which will record steps taken while the participant is hospitalized. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Fitbit with ambulation reminder alarms | Experimental | Study participants who are postoperative for colorectal surgery will wear a Fitbit (a wireless activity tracking device) to count steps taken during their postoperative hospitalization. In addition to being educated on the importance of postoperative ambulation, this arm will have 5 alarms every day reminding them to ambulate. Receives: Behavioral: Education regarding ambulation; Behavioral: Ambulation reminder alarms; Other: Fitbit |
| Fitbit without ambulation reminder alarms | Active comparator | Study participants who are postoperative for colorectal surgery will wear a Fitbit (a wireless activity tracking device) to count steps taken during their postoperative hospitalization. Participants will be educated on the importance of postoperative ambulation but will not have ambulation reminder alarms. Receives: Behavioral: Education regarding ambulation; Other: Fitbit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of number of steps taken between study arms
The number of steps taken by each participant will be measured by a Fitbit, which is a wireless activity tracking device. The number of steps taken will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. The Fitbit is commercially available and is worn on the wrist. Data will be collected from the Fitbit wirelessly using a dedicated study data collection phone and linked with an anonymized patient identifier. Data collection phones attached to chargers will be placed in patient rooms within range of the hospital bed to enable automatic wireless data collection.
Measured: Up to 10 days (postoperative day 0 through postoperative day 9)
Secondary outcomes (5)
Comparison of time to first ambulation between study arms
The duration of time from administration of the Fitbit device until first postoperative ambulation will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. Participants cleared to ambulate will be given a package containing the Fitbit device, paired study phone, and chargers while in the Post Anesthesia Care Unit (PACU). Participants will be instructed to equip the device prior to discharge from the PACU.
Measured: Up to 10 days (postoperative day 0 through postoperative day 9)
Comparison of incidence of prolonged postoperative ileus between study arms
The incidence of prolonged postoperative ileus during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms.
For this study, postoperative ileus is defined as the interval from surgery until there is passage of flatus or stool and an oral diet is tolerated. Prolonged postoperative ileus is determined to be present if two or more of the following criteria are met on or after postoperative day 4, without prior resolution of postoperative ileus:
- Nausea or vomiting
- The inability to tolerate an oral diet over 24 hours
- Absence of flatus over 24 hours
- Abdominal distension
- Radiologic confirmation
Measured: Up to 10 days (postoperative day 0 through postoperative day 9)
Comparison of incidence of pulmonary complications between study arms
The incidence of pulmonary complications during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. For this study, pulmonary complications are defined as respiratory failure requiring mechanical ventilation, pneumonia, atelectasis requiring bronchoscopic intervention, or pneumothorax or pleural effusion requiring percutaneous intervention.
Measured: Up to 10 days (postoperative day 0 through postoperative day 9)
Comparison of incidence of venous thromboembolism between study arms
The incidence of venous thromboembolism occurring during hospitalization will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. Venous thromboembolism is when a blood clot (thrombus) forms within a vein and includes deep vein thrombosis (DVT) and pulmonary embolism (PE).
Measured: Up to 10 days (postoperative day 0 through postoperative day 9)
Comparison of length of postoperative hospital stay between study arms
The length of hospitalization following surgery will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms.
Measured: Up to 10 days (postoperative day 0 through postoperative day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Sean Sullivan MD, Emory University
- Investigators
- Patrick S Sullivan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833324
- Sponsor's protocol ID
- IRB00088864
- Status last verified
- Oct 2017
- First submitted
- 12 Jul 2016
- Last updated
- 17 Oct 2017
- 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 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Fitbit (a Mobile Tracking Device) Increase Ambulation of Colorectal Surgical Patients in the Postoperative Period?
- ClinicalTrials.gov ID
- NCT02833324
- Acronym / sponsor ID
- IRB00088864
- Conditions
- Postoperative Care
- Keywords
- Postoperative Period, Colorectal Surgery, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- 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.
This trial will investigate whether using reminder alarms with a wireless activity tracking device (Fitbit) will increase daily ambulation in individuals who have just had colorectal surgery.
Detailed description
Early mobilization after surgery has been shown to reduce recovery time, incidence of venous thromboembolism, length of hospital stay and both pulmonary and general post-operative complications. Ambulation is also a main tenant of a fast-track recovery protocol known as Enhanced Recovery After Surgery (ERAS), which is commonly used among colorectal surgical practices and being implanted across other surgical practices. Despite evidence supporting its benefit, early ambulation has been identified as the one of the most difficult clinical interventions to enforce and to measure.
The primary objective of this trial is to investigate whether the use of wireless activity tracking device (Fitbit) with 5 daily reminder alarms will increase daily ambulation on postoperative day 0 until post operative day 9 or hospital discharge (whichever occurs first). Secondary objectives include evaluating the effect of Fitbit as a motivating factor on the frequency of postoperative ileus, time to return of bowel function, number of venous thromboembolism (VTE), pneumonia (PNA) and other pulmonary complications, number of code Medical Emergency Team (MET) alerts, and overall cost saving.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit with ambulation reminder alarms | Experimental | Behavioral: Education regarding ambulation, Behavioral: Ambulation reminder alarms, Other: FitbitStudy participants who are postoperative for colorectal surgery will wear a Fitbit (a wireless activity tracking device) to count steps taken during their postoperative hospitalization. In addition to being educated on the importance of postoperative ambulation, this arm will have 5 alarms every day reminding them to ambulate. |
| Fitbit without ambulation reminder alarms | Active comparator | Behavioral: Education regarding ambulation, Other: FitbitStudy participants who are postoperative for colorectal surgery will wear a Fitbit (a wireless activity tracking device) to count steps taken during their postoperative hospitalization. Participants will be educated on the importance of postoperative ambulation but will not have ambulation reminder alarms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing an elective surgical procedure in colorectal services at Emory University Hospital
Key exclusion criteria (3 listed)
- Post-surgical admission into the intensive care unit (ICU)
- Have an open abdomen due to surgical complications
- Wound Vacuum Assisted Closure (VAC) dependent
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 |
|---|---|---|
| Education regarding ambulationThe participants will be educated on the importance of postoperative ambulation during the recovery period. | Behavioural | Fitbit with ambulation reminder alarms, Fitbit without ambulation reminder alarms |
| Ambulation reminder alarmsParticipants in the intervention arm will receive 5 daily alarms to prompt them to ambulate. Alarms will be set to ring at 9am, 11am, 2pm, 5pm and 9pm. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first. | Behavioural | Fitbit with ambulation reminder alarms |
| FitbitParticipants who are postoperative for colorectal surgery, who have been cleared to ambulate during recover, will be equipped with an off-the-shelf Fitbit device (a wireless activity tracking device) which will record steps taken while the participant is hospitalized. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first. | Other | Fitbit with ambulation reminder alarms, Fitbit without ambulation reminder alarms |
Primary outcome
Comparison of number of steps taken between study arms
Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)
The number of steps taken by each participant will be measured by a Fitbit, which is a wireless activity tracking device. The number of steps taken will be compared between the study arm receiving the ambulation reminder alarms and the study arm without reminder alarms. The Fitbit is commercially available and is worn on the wrist. Data will be collected from the Fitbit wirelessly using a dedicated study data collection phone and linked with an anonymized patient identifier. Data collection phones attached to chargers will be placed in patient rooms within range of the hospital bed to enable automatic wireless data collection.
5 secondary outcomes
Comparison of time to first ambulation between study arms
Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)
Comparison of incidence of prolonged postoperative ileus between study arms
Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)
Comparison of incidence of pulmonary complications between study arms
Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)
Comparison of incidence of venous thromboembolism between study arms
Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)
Comparison of length of postoperative hospital stay between study arms
Time frame: Up to 10 days (postoperative day 0 through postoperative day 9)
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 Oct 2017.
- 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.
Patrick S Sullivan, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education regarding ambulation, Ambulation reminder alarms and Fitbit in people with Postoperative Care, run by Emory University 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 1 inclusion and 3 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 Oct 2017. 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?
Comparison of number of steps taken between study arms (time frame: Up to 10 days (postoperative day 0 through postoperative day 9)). 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 Oct 2017.