Study for the clinical validation of a medical device for prioritising follow-up visits in patients at risk of melanoma (CVCSD_VC_2402)

Study type

• Study topic:
  Medical device
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes

  Healthcare resource utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-only

  Cohort

Study drug and medical condition

• Name of medicine, other:
  The medical device under investigation is Legit.Health Plus
• Medical condition to be studied:
  Malignant melanoma

Population studied

• Short description of the study population:
  Adult patients (≥ 18 years) at risk of melanoma and treated in the dermatology department of the Hospital de la Santa Creu i Sant Pau in Barcelona will be recruited during a follow-up visit they had already scheduled with the Department, after confirming that they meet the inclusion criteria.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest, other:
  patients with dermatological lesions suspected of being malignant
• Estimated number of subjects:
  139

Study design details

• Study design:
  A quasi-experimental study without a control group will be conducted to evaluate the impact of the Legit.Health device for the rescheduling of patient follow-up visits. Patients will take photographs of their own skin lesions, which will be analysed by Legit.Health.
• Main study objective:
  The primary objective of this study is to evaluate the impact of the Legit.Health medical device on the prioritisation of dermatology follow-up visits in patients at risk of melanoma.; ; Secondary objectives include:; To evaluate the accuracy of the LH algorithm in estimating the diagnostic probability of various clinical dermatological conditions.; To estimate the mean wait time until the next visit after using the LH in patients at risk of melanoma and evaluate its potential benefit in reducing this risk.; To compare the number of in-person follow-up visits in the 6 months prior to using Legit.Health with the number of visits during the study (with the use of Legit.Health).; To evaluate healthcare professionals' satisfaction with the use of the Legit.Health medical device.; To evaluate patient satisfaction with the use of the Legit.Health medical device, and with the new care pathway.;
• Setting:
  This study will be carried out in the department of Dermatology of the Santa Creu i Sant Pau University Hospital. For this purpose, 140 patients suspected of malignancy will be recruited. ; The study will have a duration of 16 months to be completed. Patients should meet the following acceptance criteria: ; Patients at high risk for melanoma: patients with a personal or family history of melanoma, dysplastic nevus syndrome (>100 nevi with variability in shape, size, and/or color), patients with a known genetic mutation that increases the risk of familial melanoma (CDKN2A, CDK4, MITF, BAP1, POT1, TERT, MC1R polymorphisms, among others).; Patients aged 18 years or older.; Patients who have signed the informed consent form for the study.; Must have a smartphone.; Must know how to use WhatsApp (minimum digital proficiency).; ; In this way, the dermatologist will receive and review the images taken by patients. They will also review the output of the device and, with this data, will decide if this patient must be prioritised and see earlier by the dermatologist.
• Data analysis plan:
  To evaluate the potential impact of implementing Legit.Health on follow-up visits, the rescheduling rate (%) and the average wait time until the next follow-up visit will be estimated. ; In addition, the average reduction in wait time until the follow-up visit will be estimated, compared to regular scheduling. ; Furthermore, the number of in-person follow-up visits during the 6 months prior to the start of the study will be compared with the number of in-person follow-up visits during the study to determine whether these decrease, remain the same, or increase.; ; To evaluate the accuracy of the HL risk score, the Area Under the Curve (AUC) will be calculated by class, using the final diagnosis at the final visit as the gold standard.; The level of satisfaction with Legit.Health among professionals will be measured using the System Usability Scale (SUS), and that of patients will be measured using a specific satisfaction questionnaire. ; The scale scores will be analysed through a descriptive analysis of the overall scores obtained globally and for each dimension. All analyses will be conducted using Python or R software. P values ​​< 0.05 will be considered statistically significant, and 95% confidence intervals will be applied to the estimates.;