A Randomised Controlled Trial of ePROM-Guided Flexible Scheduling in Dermatology

June 29, 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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Flexible ePROM-guided Scheduling System
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.
Behavioral: electronic patient reported outcome measures (ePROMs)
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.
Behavioral: electronic patient reported outcome measures (ePROMs)
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Hospital, Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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