Wound And Symptom Tracking After Colorectal Surgery Using How2trak (NCT04869774) | Clinical Trial Compass
UnknownNot Applicable
Wound And Symptom Tracking After Colorectal Surgery Using How2trak
80 participantsStarted 2021-05
Plain-language summary
The purpose of this study is to assess the feasibility of using a mobile application (app) called how2trak to improve people's experience, wound surveillance, and detection of surgical site infections (SSI) after colorectal surgery while reducing in-person interactions for patients during the COVID-19 pandemic.
This will inform the implementation of a full-scale trial to establish if surveillance of someone's incision and symptoms using how2trak improves SSI detection and management compared to standard care (involving a single post-operative surgery clinic visit).
The data collected will contribute to a broader dataset of people with SSI surveillance to be used in developing a clinical decision support system.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be 16 years of age or older who are being discharged from hospital after undergoing semi-urgent, urgent, or elective abdominal surgery by a colorectal surgeon at The Ottawa Hospital, and have provided informed consent to participate.
Patients enrolled in other clinical trials will still be candidates for this feasibility trial.
Clinicians using the how2trak app in this study will be considered study participants as well. They will be asked to complete the "Patient and Clinician Survey of Application". This survey addresses the experience with the use of the H2T app their feedback regarding usability is fundamental for future improvement.
Exclusion Criteria:
* Individuals will be excluded if less than 16 years of age; have no access or ability to use a mobile device; no cellular data/WiFi access; and/or cannot read and write in English.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Capability for enrollment
Timeframe: 6 months
2
Feasibility of the randomization processes
Timeframe: 6 months
3
How2trak compliance
Timeframe: 6 months
4
How2trak usability, delivery and compliance
Timeframe: 6 months
5
Monitoring of protocol deviation and safety
Timeframe: 6 months
6
Feasibility of data extraction
Timeframe: 6 months
7
Resources and time required to conduct the feasibility trial will be assessed