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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07065201
Acronym
DENIM
Enrollment
10000
Registered
2025-07-15
Start date
2022-10-01
Completion date
2025-04-01
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

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.

Sponsors

Jeroen Bosch Ziekenhuis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

single center randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of late cancellationsDay of surgeryUnexpected cancellation of a scheduled surgical case on the day of surgery, prior to the procedure taking place.

Secondary

MeasureTime frameDescription
Adherence to preoperative instructionsDay of surgeryAdherence 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.
Patient satisfaction7 days after surgeryPatient 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).
Care provider satisfactionAt 6 and 12 months after implementationpreoperative 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)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026