Recruiting

Integrated Monitoring App

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT04236128

Conditions

Colorectal Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mobile App

Study Details

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.

Conditions

Colorectal Disorders

Study ID

NCT04236128

Start date

May 25, 2021

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

670 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention Group

The intervention group will receive the same usual care as the control group plus be enrolled in the integrated discharge monitoring system.

active comparator: Control Group

The control group will receive usual follow up care that is currently provided at the 3 participating centres.

Interventions

Mobile App

The app will be provided to patients in hospital on post-operative day 3. On the day of discharge, the patient will be emailed a "Daily Health Check" and receive subsequent "Daily Health Check" emails on Day 1-14, 21 and 30 days following discharge. The "Daily Health Check" is a tailored questionnaire to elicit their symptoms and status of post-operative recovery. After the patient has completed the "Daily Health Check", a "Daily Health Check Summary" is emailed to the patient that summarizes their responses and provides appropriate action recommendations based on their responses ranging from: (i) suggestions for educational modules, (ii) expect a call from your health care team in the next 24 hours, (iii) call your surgeon's office today or (iv) go to the nearest emergency room. The patient's "Daily Health Check" responses are displayed in real time on a secure website that automatically "red flags" extreme responses to alert the health care team to contact the patient by telephone.

Primary outcome measure

  • 30-day unplanned hospital visit rate [ Time Frame: 30 Days ]

Central Contacts and Locations

Central contacts

Selina Research Coordinator

416-586-4800selina.schmocker@sinaihealth.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2026-06-22.