Rate of Late CancellationDENIMNCT07065201
DENIM-trial: Digital prE-operative patieNt guIdance systeM
A study testing Mobile application for preoperative patient guidance in people with Rate of Late Cancellation and Patient Adherence to Preoperative Instructions, run by Jeroen Bosch Ziekenhuis at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rate of Late Cancellation, Patient Adherence to Preoperative Instructions, Patient Satisfaction
- What is being tested?
- Mobile application for preoperative patient guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2022to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age < 18 years
- emergency surgery
- language barrier
- no consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Digital prE-operative patieNt guIdance systeM (DENIM) in Enhancing Preparation of Elective Patients Undergoing Anesthesia: a Randomized Controlled Trial
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.
- Conditions
- Rate of Late Cancellation, Patient Adherence to Preoperative Instructions, Patient Satisfaction, Care Givers Satisfaction
- Being tested
- Mobile application for preoperative patient guidance, Mobile application and standard care
- Keywords
- patient guidance, mobile application, digital support, late cancellations, adherence, preoperative instructions, satisfaction
- Medical subject headings
- Patient Satisfaction, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application for preoperative patient guidanceDevice
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 careDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Mobile application and standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of late cancellations
Unexpected cancellation of a scheduled surgical case on the day of surgery, prior to the procedure taking place.
Measured: Day of surgery
Secondary outcomes (3)
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.
Measured: Day of surgery
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).
Measured: 7 days after surgery
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)
Measured: At 6 and 12 months after implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Oct 2022
- Primary completion1 Oct 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rate of Late CancellationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single center randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeroen Bosch Ziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065201
- Sponsor's protocol ID
- 2022.04.04.02
- Acronym
- DENIM
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan made yet
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Digital prE-operative patieNt guIdance systeM (DENIM) in Enhancing Preparation of Elective Patients Undergoing Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07065201
- Acronym / sponsor ID
- DENIM / 2022.04.04.02
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Jeroen Bosch ZiekenhuisUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- single center randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Mobile application for preoperative patient guidancePatients 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. |
| Control group | Placebo comparator | Device: Mobile application and standard carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- age < 18 years
- emergency surgery
- language barrier
- no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application for preoperative patient guidanceThe 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 | Intervention group |
| Mobile application and standard carePatients 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. | Device | Control group |
Primary outcome
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.
3 secondary outcomes
Adherence to preoperative instructions
Time frame: Day of surgery
Patient satisfaction
Time frame: 7 days after surgery
Care provider satisfaction
Time frame: At 6 and 12 months after implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Undecided. No plan made yet
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application for preoperative patient guidance in people with Rate of Late Cancellation and Patient Adherence to Preoperative Instructions, run by Jeroen Bosch Ziekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of late cancellations (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.