Skin-in-Sight: a Longitudinal Cohort Infrastructure for Standardized Remote Monitoring and the Evaluation of Digital Care Innovations in Chronic Skin Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Establish a longitudinal cohort infrastructure
研究概览
简要总结
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.
详细描述
Rationale. Chronic inflammatory skin diseases follow a fluctuating course, and the determinants of that course largely operate outside the clinical encounter: treatment adherence, self-management capacity, and environmental exposure to air pollution, ultraviolet radiation and pollen. These determinants are held in separate information systems and are rarely assembled for the same patient over time. Routine care records disease activity only at the moments a patient attends, and validated severity instruments such as PASI and EASI, although recommended by guidelines, are applied inconsistently in practice. Remote photographic follow-up is a plausible way to close this gap, but patient-acquired photographs vary considerably in quality, and only a modest proportion are judged clearly sufficient for clinical decision-making. This cohort therefore combines a standardized home photography procedure with a pre-specified, multiple-rater scoring procedure, and links the resulting measurements to routine care data, national pharmacy dispensing data and daily environmental exposure data.
Objectives. The primary objectives are: (1) to establish a longitudinal cohort infrastructure for patients with chronic inflammatory skin diseases that permits the embedding and evaluation of multiple randomized digital care interventions using a cohort multiple randomized controlled trial design; (2) to prospectively collect standardized longitudinal data comprising serial home photographs, patient-reported outcome measures, and clinically relevant disease outcomes derived from routine care; and (3) to create a dataset suitable for the development, training and validation of models for automated or semi-automated assessment of disease severity and disease impact from photographs and patient-reported measures.
The secondary objectives are: to describe disease trajectories over time, including patterns of stability and flare; to evaluate current dermatological care pathways by comparing outcomes and healthcare use between digitally supported and standard outpatient follow-up; to explore factors associated with disease worsening; to assess the feasibility, completeness and adherence of long-term home-based photograph and questionnaire collection in routine care; and to quantify the reliability of photograph-based severity scoring across raters of differing professional background, including the effect of access to the clinical record on scoring consistency.
Design and setting. Prospective observational cohort at two hospital dermatology departments in the Netherlands, designed as reusable research infrastructure. No intervention is assigned at cohort level; participants receive usual care. Participants are informed by their treating physician during a routine outpatient visit, contacted subsequently by the research team, given a reflection period of at least one week, and included after electronic informed consent.
Measurement schedule. Participants complete a baseline questionnaire set and a baseline photograph set at inclusion. Thereafter a fixed monthly schedule applies, at approximately day 28, identical for every participant and deliberately not responsive to symptom worsening. Each monthly session comprises a short questionnaire set and a standardized home photograph set; an extended questionnaire set is added twice yearly. Automated reminders are sent after two days and after one week, with research team contact where needed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a chronic inflammatory skin disease (psoriasis, atopic dermatitis, hidradenitis suppurativa), as determined by the treating dermatologist.
- •Currently receiving dermatological care at Medisch Spectrum Twente (MST) or Ziekenhuisgroep Twente (ZGT) at the time of inclusion.
- •Willing and able to participate in longitudinal monitoring, including completion of questionnaires and submission of standardized photographs.
- •Sufficient command of the Dutch language to understand the study information and to complete questionnaires.
排除标准
- •The patient has insufficient command of the Dutch language resulting in the insufficient ability to understand and/or answer questions
研究组 & 干预措施
Psoriasis
All patients with psoriasis
Eczema
All patients with eczema/atopic dermatitis
Hidradenitis suppurativa
All patients with hidradenitis suppurativa
结局指标
主要结局
Establish a longitudinal cohort infrastructure
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Disease trajectories(10 years)
- Risk factors(10 years)
- Assess feasibility(10 years)
- Skindex-29 symptoms total score(Every 6 months, from enrollment up to 10 years)
- Skindex-29 symptoms subscale score(Every 6 months, from enrollment up to 10 years)
- Skindex-29 emotions subscale score(Every 6 months, from enrollment up to 10 years)
- Skindex-29 functioning subscale score(Every 6 months, from enrollment up to 10 years)
- Patient Activation Measure (PAM-13) activation score(Every 6 months, from enrollment up to 10 years)
- Client Satisfaction Questionnaire, four-item short form (CSQ-4) total score(Every 6 months, from enrollment up to 10 years)
- Number of disease exacerbations(Continuously from enrollment, up to 10 years)
- Number of outpatient dermatology visits(Continuously from enrollment, up to 10 years)
- Number of remote consultations(Continuously from enrollment, up to 10 years)
- Number of hospital admissions(Continuously from enrollment, up to 10 years)
- Healthcare costs(Continuously from enrollment, up to 10 years)
- Therapy adherence(Continuously from enrollment, up to 10 years)
- Inter-rater reliability of photograph-derived PASI (intraclass correlation coefficient)(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Inter-rater reliability of photograph-derived EASI (intraclass correlation coefficient)(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Inter-rater reliability of photograph-derived IHS4 (intraclass correlation coefficient)(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Inter-rater agreement on photograph-derived refined Hurley stage (weighted kappa)(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Effect of access to the clinical record on photograph-derived PASI scoring(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Effect of access to the clinical record on photograph-derived EASI scoring(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Effect of access to the clinical record on photograph-derived IHS4 scoring(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Proportion of photograph sets meeting the pre-specified discordance threshold(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Monthly questionnaire completion rate(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Monthly photograph set submission rate(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Proportion of submitted photograph sets of sufficient quality for severity scoring(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Distribution of photograph quality failure reasons(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Body region coverage state distribution(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Scoring turnaround within 90 days(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Annual participant attrition rate(Assessed at each two-yearly cohort evaluation, up to 10 years)
- Number of actively participating participants per disease group(Assessed at each two-yearly cohort evaluation, up to 10 years)