Condition category
Surgery
Date applied
17/06/2015
Date assigned
29/06/2015
Last edited
22/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Boston University Medical Center Institutional Review Board

Sponsor details

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

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes