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Completed

NCT Number: NCT07065201

DENIM-trial: Digital prE-operative patieNt guIdance systeM

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.

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Key information

Conditions

Rate of Late Cancellation Behavior Care Givers Satisfaction Health Behavior Patient Adherence to Preoperative Instructions Patient Satisfaction Personal Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeroen Bosch Hospital

's-Hertogenbosch, 5200ME, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Rate of late cancellations

    Time frame: Day of surgery

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

Secondary outcomes

  1. Adherence to preoperative instructions

    Time frame: Day of surgery

    Adherence to instruction regarding anticoagulants, antihypertensive medication, hypoglicaemic medication, astma/COPD medication, fasting rules. This outcome will be assessed as a binary outcome (yes/no) based on wether the patients has followed all relevant preoperative instructions.

  2. Patient satisfaction

    Time frame: 7 days after surgery

    Patient satisfaction will be assessed using the Usability: System Usability Scale (SUS)/ Mobile App Usability Questionnaire (MAUQ)1. Vaarious aspects of the app's use will be evaluated including quality, quantity and timing of information provided. Satisfaction will be measured on a numerical scale from 0 (not satisfied at all) to 10 (extremely satisfied).

  3. Care provider satisfaction

    Time frame: At 6 and 12 months after implementation

    preoperative screening nurses and surgeons will be asked to complete a questionnaire at 6 and 12 months after implementation. Their experince with patient's use of the app will be assessed using a numerical rating scale ranging from 0 (not usefull at all) to 10 (extremely usefull)

Sponsors and collaborators

Lead sponsor

Jeroen Bosch Ziekenhuis

Other

Registry information

Official study title

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

Acronym: DENIM

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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