Skin-in-Sight: a Longitudinal Cohort Infrastructure for Standardized Remote Monitoring and the Evaluation of Digital Care Innovations in Chronic Skin Diseases

Condition(s) studied

Study summary

Psoriasis, atopic dermatitis (eczema) and hidradenitis suppurativa are long-term skin conditions that flare and settle over time. Most of what happens to the skin happens at home, between hospital appointments. A dermatologist usually sees the skin only on the day of the visit, which may not reflect how the condition has been over the preceding months.

This study sets up a long-term research collection, called a cohort, in which people with one of these three conditions take part from home. Once a month, participants use a certified digital health app on their own phone to answer a short set of questions about their symptoms and about how their skin affects daily life, and to take a standard set of photographs of their skin. Twice a year they answer a longer set of questions. Taking part takes about five minutes in most months and about twenty-five minutes twice a year. The app gives step-by-step guidance on lighting, distance and framing at the start of every photo session, so that the photographs can be compared from month to month.

The photographs are reviewed by trained assessors, who score how severe the skin disease looks using the scoring systems established in dermatology research. Three assessors score each set of photographs independently, and their scores are combined according to rules that are set in advance. With the participant's permission, this information is combined with information already recorded during routine care, such as changes in treatment and hospital visits; with pharmacy records showing which medicines were dispensed; and with publicly available daily measurements of air quality, sunshine, ultraviolet radiation and pollen for the area where the participant lives.

Bringing these together makes it possible to study how these conditions change over time, what happens in the period before a flare, and how treatment and the living environment relate to the course of the disease. The collected data are also intended to support the development of computer-based tools that could in future help assess skin disease from photographs.

Taking part does not change the care a participant receives. The study does not provide medical advice, and the data collected are not used for diagnosis, treatment decisions or routine follow-up. Participants who experience worsening symptoms contact their treating physician as usual.

The cohort is also designed so that studies of digital care tools can later be carried out within it, among participants who have agreed in advance to be approached. Each of those studies is registered separately.

Eligibility

Primary outcome measure(s)

• Establish a longitudinal cohort infrastructure — 10 years
  To establish a longitudinal cohort infrastructure for patients with chronic inflammatory skin diseases (psoriasis, atopic dermatitis, hidradenitis suppurativa) that enables the embedding and evaluation of multiple randomized digital care interventions using a cohort multiple randomized controlled trial (cmRCT) design.
• Psoriasis Area and Severity Index (PASI) derived from patient-acquired photographs — Monthly, from enrollment up to 10 years
  Consensus PASI score, defined as the mean of three independent scores assigned by calibrated raters from the monthly home photograph set. Psoriasis Area and Severity Index: minimum 0, maximum 72; higher scores indicate more severe disease. Assessed in participants with psoriasis.
• Eczema Area and Severity Index (EASI) derived from patient-acquired photographs — Monthly, from enrollment up to 10 years
  Consensus EASI score, defined as the mean of three independent scores assigned by calibrated raters from the monthly home photograph set. Eczema Area and Severity Index: minimum 0, maximum 72; higher scores indicate more severe disease. Assessed in participants with atopic dermatitis.
• International Hidradenitis Suppurativa Severity Score System (IHS4) derived from patient-acquired photographs — Monthly, from enrollment up to 10 years
  Consensus IHS4 score, defined as the mean of three independent scores assigned by calibrated raters from the monthly home photograph set. International Hidradenitis Suppurativa Severity Score System: weighted count of nodules, abscesses and draining tunnels; minimum 0, no predefined maximum; higher scores indicate more severe disease. Because photography of sensitive regions is optional, the photograph-derived score is interpreted as a lower bound where affected regions were not photographed. Assessed in participants with hidradenitis suppurativa.
• Refined Hurley stage derived from patient-acquired photographs — Monthly, from enrollment up to 10 years
  Consensus refined Hurley stage, defined as the median of three independent stages assigned by calibrated raters from the monthly home photograph set. Refined Hurley classification: ordinal stages \[TO CONFIRM: exact level set to be registered, i.e. I-III or IA-IIIB\]; higher stages indicate more severe disease. Assessed in participants with hidradenitis suppurativa.
• Dermatology Life Quality Index (DLQI) total score — Monthly, from enrollment up to 10 years
  Dermatology Life Quality Index, a 10-item patient-reported questionnaire on the impact of skin disease on daily life. Minimum 0, maximum 30; higher scores indicate greater impairment of quality of life.
• Numeric Rating Scale for itch, average intensity — Monthly, from enrollment up to 10 years
  Patient-reported average itch intensity over the preceding period, recorded on a Numeric Rating Scale. Minimum 0 (no itch), maximum 10 (worst imaginable itch); higher scores indicate more severe symptoms. Assessed in participants with psoriasis or atopic dermatitis.
• Numeric Rating Scale for itch, peak intensity — Monthly, from enrollment up to 10 years
  Patient-reported worst itch intensity over the preceding period, recorded on a Numeric Rating Scale. Minimum 0 (no itch), maximum 10 (worst imaginable itch); higher scores indicate more severe symptoms. Assessed in participants with psoriasis or atopic dermatitis.
• Numeric Rating Scale for pain, average intensity — Monthly, from enrollment up to 10 years
  Patient-reported average pain intensity over the preceding period, recorded on a Numeric Rating Scale. Minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate more severe symptoms. Assessed in participants with hidradenitis suppurativa.
• Numeric Rating Scale for pain, peak intensity — Monthly, from enrollment up to 10 years
  Patient-reported worst pain intensity over the preceding period, recorded on a Numeric Rating Scale. Minimum 0 (no pain), maximum 10 (worst imaginable pain); higher scores indicate more severe symptoms. Assessed in participants with hidradenitis suppurativa.
• AI modelling — 10 years
  To create a high-quality dataset that can be used for the development, training and validation of AI models for automated or semi-automated assessment of disease severity and disease impact based on photographs and PROMs.

Trial sites (3)

More Medisch Spectrum Twente trials in the Netherlands

Other trials for the same condition