- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277053
A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery
A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction: Enhanced Recovery Programs (ERP) in colorectal surgery reduce postoperative morbidity and shorten length of hospital stay with no increase in readmission rates. However, poor adherence to ERP elements remains a challenge. Recent studies suggest that the use of mobile device applications has the potential to improve patient compliance with treatment guidelines. We recently developed and pilot tested a mobile app to support an ERP for colorectal surgery which collects patient-reported recovery information and engages patients as stakeholders in their recovery process. The overall aim of this study is to estimate the extent to which the use of this mobile device app impacts adherence to postoperative ERP elements in comparison to standard preoperative education.
Methods. The proposal is for a two-group, assessor-blind, randomized trial including adult patients with colorectal diseases planned for surgical resection.
Participants will be randomly assigned into one of two groups:
- usual perioperative education and audit, or
- a mobile device application for postoperative education and self-audit.
The intervention will be delivered through a tablet present at the bedside with an application which links education, recovery planning, and daily self-assessment to a plan of care. It educates patients about daily recovery milestones and track their adherence. The primary outcome will be patient adherence to postoperative enhanced recovery elements. Other targeted outcomes include self-reported recovery, satisfaction and patient activation. According to an a priori power analysis, a sample of 104 patients (52 per group) is targeted for this trial.
Significance: This study will contribute evidence regarding the use of mobile device technology for education and the direct involvement of patients as stakeholders in postoperative recovery.
The study findings have the potential to increase patient engagement in the care pathway, which has the potential to increase compliance to pathway elements and improve postoperative outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, h3g1a4
- Montreal General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- elective laparoscopic colorectal resection.
- Proficient in english or french
Exclusion Criteria:
- intellectual disabilities
- major simultaneous procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: control
Patients receive an ipad with no app.
|
Patient receive an ipad with no application.
|
Experimental: Mobile application no stoma
Patients who did not receive a stoma receive an ipad containing the app and are instructed how to use it.
|
A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway.
Contains information, guidelines, questionnaires and feedback
|
Experimental: Mobile application stoma
Patients who receive a stoma receive an ipad containing the app and are instructed how to use it.
|
A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway.
Contains information, guidelines, questionnaires and feedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery.
Time Frame: postoperative day 2
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: one month
|
Number of days spent in the hospital after surgery
|
one month
|
Complications
Time Frame: one month
|
Comprehensive complication index (CCI)
|
one month
|
Successful Recovery
Time Frame: postoperative day 4
|
Discharge by postoperative day 4 with no complications.
|
postoperative day 4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- McgillGensurgAPPRCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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