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CompletedNCT07065201DENIMUpdated Jul 15, 2025

DENIM-trial: Digital prE-operative patieNt guIdance systeM

An interventional study of Mobile application for preoperative patient guidance and Mobile application and standard care in Rate of Late Cancellation, Patient Adherence to Preoperative Instructions and Patient Satisfaction, sponsored by Jeroen Bosch Ziekenhuis. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-15.

Sponsored by Jeroen Bosch Ziekenhuis · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Oct 2022, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
10,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Patient Satisfaction

256 studies on the registry are indexed under Patient Satisfaction; 127 are open to participants now.

This study's enrollment of 10,000 is above the median of 90 across 196 interventional studies indexed under Patient Satisfaction.

Browse Patient Satisfaction studies →

Lead sponsor

Jeroen Bosch Ziekenhuis is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • age \< 18 years
  • emergency surgery
  • language barrier
  • no consent
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
10,000 participants (actual)

Study arms

  • Experimental
    Intervention group

    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

  • Placebo comparator
    Control group

    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

  • DeviceMobile 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.

  • DeviceMobile 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.

06

What researchers measure

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.

    Time frame: Day of surgery

Secondary outcomes

  1. Adherence to preoperative instructions

    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.

    Time frame: Day of surgery

  2. Patient satisfaction

    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).

    Time frame: 7 days after surgery

  3. Care provider satisfaction

    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)

    Time frame: At 6 and 12 months after implementation

07

Study locations

1 site
  • Jeroen Bosch Hospital
    's-Hertogenbosch, 5200ME, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided — No plan made yet

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07065201
Lead sponsor
Jeroen Bosch Ziekenhuis
Responsible party
Sponsor
First posted
Jul 15, 2025
Start date
Oct 1, 2022
Primary completion
Oct 1, 2024
Completion
Apr 1, 2025
Last update
Jul 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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