- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481019
A Randomised Controlled Trial of ePROM-Guided Flexible Scheduling in Dermatology
March 15, 2026 updated by: National University Hospital, Singapore
The goal of this clinical trial is to evaluate whether an electronic patient-reported outcome measure (ePROM)-guided flexible scheduling system can improve outpatient clinic resource utilisation in patients attending dermatology outpatient clinics for routine follow-up. The main questions it aims to answer are:
- Does the intervention reduce the number of actualised outpatient visits over 12 months compared with standard fixed scheduling?
- Does the intervention group achieve higher adherence to monthly ePROM monitoring, as measured by the proportion of completed ePROM submissions?
Study Overview
Status
Not yet recruiting
Study Type
Interventional
Enrollment (Estimated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ellie Choi, MBBS
- Phone Number: 65 6908 2222
- Email: dermatology@nuhs.edu.sg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Dermatology outpatients otherwise due for a follow-up appointment within six months.
- Ability to independently navigate and complete ePROMs.
- Ability to provide informed consent (including parental consent for minors).
Exclusion Criteria:
- Patients who require fixed or scheduled in-person visits, including those needing skin cancer surveillance, bedside procedures (e.g., liquid nitrogen therapy), surgical interventions, or routine blood tests for immunosuppressive therapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
Participants in the intervention arm will not receive routine follow-up appointments at the end of their consultation.
Instead, their monthly ePROM responses will feed a two-layer Bayesian decision system to determine appointment need.
|
Monthly ePROM responses will feed a Bayesian decision system to determine appointment need, which will then be used to make recommendations to patients for scheduling of appointments.
Monthly electronic patient reported outcome measures (ePROMs) surveys will be sent to patients' mobile devices to capture self-reported disease severity data.
|
|
Active Comparator: Control Arm
Participants in the control arm will continue standard care, with follow-up appointments scheduled at the end of each consultation.
The ePROM responses may be used by patients for self-tracking and will be available to clinicians to inform decision-making at subsequent visits.
|
Monthly electronic patient reported outcome measures (ePROMs) surveys will be sent to patients' mobile devices to capture self-reported disease severity data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of actualised outpatient visits
Time Frame: baseline to week 52
|
Difference in actualised outpatient visits (in-person + teleconsult) over 12 months (effectiveness outcome).
|
baseline to week 52
|
|
Proportion of completed monthly ePROMs
Time Frame: baseline to week 52
|
Difference in proportion of completed monthly ePROMs (implementation outcome)
|
baseline to week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
No-show rate
Time Frame: baseline to week 52
|
Number of appointments missed without prior rescheduling or cancellation
|
baseline to week 52
|
|
Cancelled or rescheduled appointments
Time Frame: baseline to week 52
|
Appointments booked but cancelled or rescheduled before the actual appointment date
|
baseline to week 52
|
|
Urgent care or unscheduled visits
Time Frame: baseline to week 52
|
Emergency department visits or other urgent care visits related to patient's dermatological condition
|
baseline to week 52
|
|
Skin-specific Quality of Life Impairment
Time Frame: baseline, 6 months, 12 months
|
Changes in quality of life using the Dermatology Life Quality Index (DLQI).
Minimum Score: 0 (no impact on quality of life).
Maximum Score: 30 (extremely large impact on quality of life).
|
baseline, 6 months, 12 months
|
|
Clinician-assessed disease severity
Time Frame: baseline to week 52
|
Clinician-assessed disease severity using body surface area and the investigator global assessment on a 0-5 NRS
|
baseline to week 52
|
|
Acceptability of the intervention
Time Frame: week 52
|
Assessed using the Theoretical Framework of Acceptability
|
week 52
|
|
Perceived burden of engaging with the intervention
Time Frame: baseline, 6 months, 12 months
|
Research questionnaire assessing perceived burden of intervention use
|
baseline, 6 months, 12 months
|
|
Fidelity to the scheduling algorithm
Time Frame: baseline to week 52
|
The extent to which algorithm-generated recommendations were followed, overridden, or superseded
|
baseline to week 52
|
|
Barriers and facilitators to implementation
Time Frame: week 52
|
Explored through semi-structured qualitative interviews
|
week 52
|
|
Bayesian Decision-layer outputs
Time Frame: baseline to week 52
|
Decision-layer outputs, including monthly posterior summaries and posterior predictive probabilities for each appointment category
|
baseline to week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ellie Choi, MBBS, National University Hospital, Singapore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
December 1, 2029
Study Registration Dates
First Submitted
March 15, 2026
First Submitted That Met QC Criteria
March 15, 2026
First Posted (Actual)
March 18, 2026
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 15, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/00698
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IPD shared includes de-identified demographics, disease outcomes and measures.
IPD Sharing Time Frame
IPD and supporting information will be available from the time of publication and for four years thereafter.
IPD Sharing Access Criteria
IPD and supporting information will be available from the study team on a case-by-case basis upon request.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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