Colorectal DisordersNCT03277053
A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery
A study testing Mobile application in people with Colorectal Disorders, run by Dr. Liane S. Feldman at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- Mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 24 Aug 2016to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective laparoscopic colorectal resection.
- Proficient in english or french
Who cannot join
- intellectual disabilities
- major simultaneous procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial
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.
Read the 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.
- Conditions
- Colorectal Disorders
- Being tested
- Mobile application, Control.
- Keywords
- colorectal, laparoscopic, application, ERP, adherence, mobile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationDevice
A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback
Control.Other
Patient receive an ipad with no application.
| Study group | Role | What they receive |
|---|---|---|
| control | Sham comparator | Patients receive an ipad with no app. Receives: Other: Control. |
| Mobile application no stoma | Experimental | Patients who did not receive a stoma receive an ipad containing the app and are instructed how to use it. Receives: Device: Mobile application |
| Mobile application stoma | Experimental | Patients who receive a stoma receive an ipad containing the app and are instructed how to use it. Receives: Device: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: postoperative day 2
Secondary outcomes (3)
Length of stay
Number of days spent in the hospital after surgery
Measured: one month
Complications
Comprehensive complication index (CCI)
Measured: one month
Successful Recovery
Discharge by postoperative day 4 with no complications.
Measured: postoperative day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start24 Aug 2016
- Primary completion1 Oct 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Liane S. Feldman
- Sponsor type
- University, hospital or other
- Collaborators
- Society of American Gastrointestinal and Endoscopic Surgeons
- Responsible party
- Sponsor-investigator, Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Liane Feldman, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277053
- Sponsor's protocol ID
- McgillGensurgAPPRCT
- Status last verified
- Mar 2018
- First submitted
- 11 Jul 2017
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Device App to Improve Adherence to an Enhanced Recovery Program for Colorectal Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03277053
- Acronym / sponsor ID
- McgillGensurgAPPRCT
- Conditions
- Colorectal Disorders
- Keywords
- colorectal, laparoscopic, application, ERP, adherence, mobile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Dr. Liane S. FeldmanUniversity, hospital or other
- Collaborators
- Society of American Gastrointestinal and Endoscopic Surgeons
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Sham comparator | Other: Control.Patients receive an ipad with no app. |
| Mobile application no stoma | Experimental | Device: Mobile applicationPatients who did not receive a stoma receive an ipad containing the app and are instructed how to use it. |
| Mobile application stoma | Experimental | Device: Mobile applicationPatients who receive a stoma receive an ipad containing the app and are instructed how to use it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective laparoscopic colorectal resection.
- Proficient in english or french
Key exclusion criteria (2 listed)
- intellectual disabilities
- major simultaneous procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile applicationA mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback | Device | Mobile application no stoma, Mobile application stoma |
| Control.Patient receive an ipad with no application. | Other | control |
Primary outcome
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).
3 secondary outcomes
Length of stay
Time frame: one month
Complications
Time frame: one month
Successful Recovery
Time frame: postoperative day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liane Feldman, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application in people with Colorectal Disorders, run by Dr. Liane S. Feldman at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of 5 patient-dependent pathway interventions that involve patient participation on the initial 48 hrs after surgery. (time frame: postoperative day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2018.