Utilizing activity trackers to increase postoperative ambulation

ISRCTN	ISRCTN96991582
DOI	https://doi.org/10.1186/ISRCTN96991582
Secondary identifying numbers	N/A

Submission date: 17/06/2015
Registration date: 29/06/2015
Last edited: 22/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Ryan Macht
Public

88 East Newton Street, Collamore - C 500
Boston
02118
United States of America

ORCID ID	0000-0002-1944-1653

Study information

Study design	Single-center randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Utilizing activity trackers to increase postoperative ambulation: a novel quality improvement strategy to quantify ambulation and decrease bariatric surgery complications
Study objectives	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(s)	Boston University Medical Center IRB, 28/01/2015, ref: H-33593
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/03/2015
Completion date	31/03/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	150
Key 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).
Key exclusion criteria	Patients undergoing revisional bariatric surgery or emergent/elective reoperations
Date of first enrolment	01/03/2015
Date of final enrolment	01/03/2016

Locations

Countries of recruitment

United States of America

Study participating centre

Boston Medical Center

One Boston Medical Center Place
Boston
MA 02118
United States of America

Sponsor information

Boston University Medical Center Institutional Review Board
Research organisation

560 Harrison Avenue
3rd floor, Suite 300
Boston
02118
United States of America

"ROR"	https://ror.org/05qwgg493

Funders

Funder type

Research organisation

Boston Medical Center Resident Quality Improvement Council (USA)

No information available

Results and Publications

Intention to publish date	01/04/2016
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan