Plain English Summary
Background and study aims
We are investigating the use of activity trackers as a novel quality improvement strategy to increase postoperative ambulation (walking after surgery). Postoperative ambulation is frequently recommended in surgical guidelines, but often difficult for patients and hospital staff to comply with. Activity trackers have been successfully used in outpatient clinics as a motivation tool for ambulation and health monitoring, but have rarely been used in the inpatient surgical setting. This study aims to test how well activity trackers perform in increasing postoperative ambulation.
Who can participate?
Adult patients having an bariatric operation performed at our center ( that is, laparoscopic roux-n-y gastric bypass, laparoscopic adjustable gastric band, and laparoscopic sleeve gastrectomy).
What does the study involve?
All participants are given activity trackers and then randomly allocated into one of two groups. Those in group 1 are given feedback on the number of steps they tale. Those in group 2 do not receive this feedback. The number of steps taken each day is then compared between the two groups.
What are the possible benefits and risks of participating?
The benefits of participating are limited to the use of the activity trackers and there is no financial compensation for subjects. There are no major risks to wearing the activity trackers.
Where is the study run from?
Boston Medical Center (USA)
When is the study starting and how long is it expected to run for?
March 2015 to March 2016
Who is funding the study?
Boston Medical Center Resident Quality Improvement Council (USA)
Who is the main contact?
Dr Ryan Macht
Trial website
Contact information
Type
Public
Primary contact
Dr Ryan Macht
ORCID ID
http://orcid.org/0000-0002-1944-1653
Contact details
88 East Newton Street
Collamore - C 500
Boston
02118
United States of America
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Utilizing activity trackers to increase postoperative ambulation: a novel quality improvement strategy to quantify ambulation and decrease bariatric surgery complications
Acronym
Study hypothesis
The goal of this study is to evaluate activity tracker feedback as a strategy to increase early ambulation after surgery and to assess the association of early mobility with postoperative outcomes. We hypothesize that feedback from activity trackers will increase postoperative ambulation and lead to decreased ambulation-relation complications.
Ethics approval
Boston University Medical Center IRB, 28/01/2015, ref: H-33593
Study design
Single-center randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Postoperative complications following bariatric surgery
Intervention
All subjects will receive an activity tracker following surgery with randomization into two groups:
1. Participants receive ambulation feedback as an inpatient
2. Participants do not receive any feedback
Intervention type
Device
Phase
Drug names
Primary outcome measures
Postoperative ambulation (average steps/day)
Secondary outcome measures
1. Postoperative readmission or emergency department visit
2. Venous thromboembolism
3. Postoperative complications
4. Weight loss
Patient experience outcomes will be obtained by a short survey given to all study participants at their two-week postoperative visit.
Overall trial start date
01/03/2015
Overall trial end date
31/03/2016
Reason abandoned
Eligibility
Participant inclusion criteria
All patients undergoing any of the three bariatric operations performed at our center (laparoscopic roux-n-y gastric bypass, laparoscopic adjustable gastric band, and laparoscopic sleeve gastrectomy).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
Patients undergoing revisional bariatric surgery or emergent/elective reoperations
Recruitment start date
01/03/2015
Recruitment end date
01/03/2016
Locations
Countries of recruitment
United States of America
Trial participating centre
Boston Medical Center
One Boston Medical Center Place
Boston
MA 02118
United States of America
Funders
Funder type
Research organisation
Funder name
Boston Medical Center Resident Quality Improvement Council (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to publish the results of our study in the Winter/Spring of 2016. We will publish all initial results on whether our feedback intervention with activity trackers increased postoperative ambulation. Additionally we will publish whether the amount of postoperative ambulation was associated with any clinical outcomes.
Intention to publish date
01/04/2016
Participant level data
Available on request
Results - basic reporting
Publication summary