A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery
1 other identifier
interventional
104
1 country
1
Brief Summary
A randomized control trial on patients undergoing laparoscopic colorectal resection in an Enhanced Recovery Program (ERP). The intervention is delivered via an electronic application containing guidelines, information, and tailored feedback. The hypothesis is that the application will improve adherence to the ERP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2016
CompletedFirst Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
September 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 26, 2018
March 1, 2018
1.1 years
July 11, 2017
March 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.
Questionnaire including 5 pathway interventions that involve patient participation during the first 48 hours after surgery (mobilization, gum chewing, consumption of oral liquids, breathing exercises, nutritional supplement).
postoperative day 2
Secondary Outcomes (3)
Length of stay
one month
Complications
one month
Successful Recovery
postoperative day 4
Study Arms (3)
control
SHAM COMPARATORPatients receive an ipad with no app.
Mobile application no stoma
EXPERIMENTALPatients who did not receive a stoma receive an ipad containing the app and are instructed how to use it.
Mobile application stoma
EXPERIMENTALPatients who receive a stoma receive an ipad containing the app and are instructed how to use it.
Interventions
A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback
Eligibility Criteria
You may qualify if:
- elective laparoscopic colorectal resection.
- Proficient in english or french
You may not qualify if:
- intellectual disabilities
- major simultaneous procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal general Hospital
Montreal, Quebec, h3g1a4, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Liane Feldman, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Department of Surgery, McGill University Director, General Surgery Clinical Teaching Unit, Montreal General Hospital. Director, Division of General Surgery at the MUHC and McGill University. Program Director, MIS Fellowship Program.
Study Record Dates
First Submitted
July 11, 2017
First Posted
September 8, 2017
Study Start
August 24, 2016
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
March 26, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share