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Not yet recruiting NCT07481019

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

No phase Interventional Chronic Dermatological Conditions Eczema Urticaria Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Flexible ePROM-guided Scheduling System, electronic patient reported outcome measures (ePROMs).
Who it may be relevant to
Registry conditions: Chronic Dermatological Conditions, Eczema, Urticaria, Psoriasis. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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?

Interventions

  • 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.

Primary outcome measures

  • Number of actualised outpatient visits [Time frame: baseline to week 52]
  • Proportion of completed monthly ePROMs [Time frame: baseline to week 52]
Secondary outcome measures (10)
  • No-show rate [Time frame: baseline to week 52]
  • Cancelled or rescheduled appointments [Time frame: baseline to week 52]
  • Urgent care or unscheduled visits [Time frame: baseline to week 52]
  • Skin-specific Quality of Life Impairment [Time frame: baseline, 6 months, 12 months]
  • Clinician-assessed disease severity [Time frame: baseline to week 52]
  • Acceptability of the intervention [Time frame: week 52]
  • Perceived burden of engaging with the intervention [Time frame: baseline, 6 months, 12 months]
  • Fidelity to the scheduling algorithm [Time frame: baseline to week 52]
  • Barriers and facilitators to implementation [Time frame: week 52]
  • Bayesian Decision-layer outputs [Time frame: baseline to week 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07481019 · 2023/00698

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗