NCT04236128 Home to Stay Mobile App for Colorectal Surgery
| NCT ID | NCT04236128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mount Sinai Hospital, Canada |
| Condition | Colorectal Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 670 participants |
| Start Date | 2021-05-25 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 670 participants in total. It began in 2021-05-25 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Colorectal surgery includes surgery for colorectal cancer, inflammatory bowel disease and other benign diseases such as diverticulitis. In Canada, approximately 21,000 colorectal surgeries are performed each year. Patients undergoing colorectal surgery face high rates of unplanned hospital visits including readmission to hospital and Emergency Room (ER) visits. These unplanned hospital visits lead to significant distress and anxiety for patients and increased health care costs. Research Aims: The goal is to evaluate the use of an integrated discharge monitoring system with a mobile application (app) to support colorectal surgery patients at home following discharge from hospital. Methods: The study will include 3 hospitals across Canada. Patients will be assigned to either a control group or intervention group. Control group patients will receive standard follow up care after going home following surgery. Intervention group patients will be enrolled in an integrated discharge monitoring system using an app to monitor their progress at home following discharge after surgery. The main outcomes are to measure the number of patients with unplanned hospital visits within 30 days of discharge following surgery, the quality of patient recovery and confidence managing one's own health care. Patients are eligible if they are being discharge home after having elective colorectal surgery, are 18 years or older and speak and understand English or French. At the end of the study, the outcomes between the control group and intervention group will be compared to look for important differences. Expected Outcomes: It is expected that the results of this study will show that the integrated discharge monitoring system will lead to a significant improvement in the quality of patient recovery and self-confidence with one's own health care, as well as significantly reduce the number of unplanned hospital visits for patients undergoing colorectal surgery in Canada.
Eligibility Criteria
Inclusion Criteria: * any patient who is being discharged to home after undergoing elective colorectal surgery * 18 years or older * able to speak and understand English or French * provides informed consent Exclusion Criteria: * post-operative admission less than 3 days * requiring discharge to rehabilitation centre to recover prior to being able to go home
Contact & Investigator
Erin Kennedy
PRINCIPAL INVESTIGATOR
MOUNT SINAI HOSPITAL
Frequently Asked Questions
Who can join the NCT04236128 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04236128 currently recruiting?
Yes, NCT04236128 is actively recruiting participants. Contact the research team at selina.schmocker@sinaihealth.ca for enrollment information.
Where is the NCT04236128 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04236128 clinical trial?
NCT04236128 is sponsored by Mount Sinai Hospital, Canada. The principal investigator is Erin Kennedy at MOUNT SINAI HOSPITAL. The trial plans to enroll 670 participants.