NCT07065201

DENIM-trial: Digital prE-operative patieNt guIdance systeM

Effectiveness of a Digital prE-operative patieNt guIdance systeM (DENIM) in Enhancing Preparation of Elective Patients Undergoing Anesthesia: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (actual)
• Sponsor: Jeroen Bosch Ziekenhuis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this RCT is to assess the effectiveness of a mobile application in enhancing the preoperative preparation of patients scheduled for elective surgery under anesthesia or procedural sedation. The main object is to evaluate the effect of preoperative instructions, delivered through reminders and push notifications, on the rate of late cancellations. Secondary outcomes are adherence to preoperative instructions, patient satisfaction, and care provider satisfaction.

Detailed description

Participants will be randomly assigned to one of two groups: 1) Intervention group: patients will be asked to download a mobile application specifically designed for preoperative guidance. Through this app they will receive all relevant preoperative instructions via automated reminders and push notifications (e.g., fasting and medication adjustment). In addition, they will be asked to complete a short questionnaire via the app. 2) Control group: patients will download the same mobile application and will be asked to fill out the same questionnaire. However, they will not receive any preoperative instructions through the app. All patients in both groups will continue to receive the standard written instructions. App access will be maintained until five days after surgery.

Conditions

• Rate of Late Cancellation
• Patient Adherence to Preoperative Instructions
• Patient Satisfaction
• Care Givers Satisfaction

Interventions

Type	Name	Description
DEVICE	Mobile application for preoperative patient guidance	The mobile application provides patients with tailored information during the preoperative period until seven days after surgery. 1) Before the preoperative outpatient clinic visits, patient will receive information regarding the preoperative screening process and an overview of available anesthesia techniques through videos embedded in the app. 2) After approval for surgery and during the period leading up to the day of surgery, they will receive instructions concerning medication adjustment, lifestyle modifications, fasting rules, and hygiene measures.
DEVICE	Mobile application and standard care	Patients in the control group will be asked to download the same mobile app but they will not receive the same tailored information as those in the intervention group. Instead, they will be provided with standard preoperative information and instructions. In addition, they will be asked to fill out the same questionnaire as the intervention group.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-01
• Completion: 2025-04-01
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: Netherlands