DENIM-trial: Digital prE-operative patieNt guIdance systeM

NCT07065201 | Completed

• 1 other identifier: 2022.04.04.02
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

patient guidance; mobile application; digital support; late cancellations; adherence; preoperative instructions; satisfaction

Outcome Measures

Primary Outcomes (1)

• Rate of late cancellations

  Unexpected cancellation of a scheduled surgical case on the day of surgery, prior to the procedure taking place.

  Day of surgery

Secondary Outcomes (3)

• Adherence to preoperative instructions

  Day of surgery

• Patient satisfaction

  7 days after surgery

• Care provider satisfaction

  At 6 and 12 months after implementation

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in the intervention arm are individuals scheduled for elective surgery who 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, medication adjustment). In addition, they will be asked to complete a short questionnaire via the app.

Device: Mobile application for preoperative patient guidance

Control group

PLACEBO COMPARATOR

Patients in the control group are individuals scheduled for elective surgery who will be asked to download the same mobile application as the intervention group. However, they will not receive any preoperative instructions through the app. They will be asked to fill out the same questionnaire as the control group.

Device: Mobile application and standard care

Interventions

Mobile application for preoperative patient guidance DEVICE

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.

Intervention group

Mobile application and standard care DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years
• patients scheduled for elective surgery under anesthesia or procedural sedation
• Possession of a mobile phone or tablet
• Access to a valid email address for study communication

You may not qualify if:

• age \< 18 years
• emergency surgery
• language barrier
• no consent

Sponsors & Collaborators

• Jeroen Bosch Ziekenhuis: lead

Study Sites (1)

Jeroen Bosch Hospital

's-Hertogenbosch, 5200ME, Netherlands

Location

MeSH Terms

Conditions

Patient Satisfaction; Personal Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single center randomized trial

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 15, 2025
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

NL (1)