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ID
Source
Brief title
Health condition
Premalignant skin lesions, skin malignancies (including: melanomas, basal cell carcinomas, cutaneous squamous cell carcinomas and rare skin cancers) and benign skin tumors.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the difference in skin tumor related care between the intervention group and the control group during 12 months, which is assessed by comparison of:
- The incidence of malignant skin tumors in Palga (national pathology database).
- The incidence of claims for benign skin tumors.
- The incidence of claims for (pre)malignant skin tumors.
Secondary outcome
The secondary outcomes have been defined as:
- The cost-effectiveness of the SVA, which will be measured by the costs per detected skin cancer.
- The impact of SVA usage on primary care, which will be measures by surgical claims in primary care, although rather general coding will be a limiting factor.
- Comparison of the proportion of dermatological care received between the intervention group and the control group: Dermatological care will be specified for new dermatology consultations, follow-up visits, performed biopsies and excisions.
- The proportion of false negative melanomas within 2 years after using the SVA based on linkage with Palga.
Background summary
Background: Recently, deep learning algorithms have been integrated into smartphone applications that allow risk assessments of skin lesions to be performed at home by people in the general population. The SkinVision app (SVA) is a CE marked class 1 medical device that uses a machine learning algorithm to classify a skin lesion as low or high risk. Based on this classification, users can be advised to visit a doctor when the lesion is at high risk of skin cancer. The SVA is reimbursed by multiple healthcare insurances in Europe, including the Netherlands. Although previous studies have tested the accuracy of the SVA, the impact of smartphone-based skin cancer risk assessments on health care systems is unknown.
Objective: In this prospective randomized study, we will study the effects of the SVA on healthcare consumption in the Netherlands on a population-wide level.
Methods: In this randomized controlled trial, all customers (+/-200.000) of DSW aged >18 years will be invited to participate. After randomization, the intervention group will be offered to use the SVA at no extra costs for the duration of one year. After this year the control group will receive access to the SVA for the period of one year. Both groups will enter a passive follow-up for 2 years after the use of the SVA. Data will be collected on the incidence of (pre)malignant and benign skin lesions through Palga and on the incidence of claims from the DSW database.
Study objective
Our hypothesis is that the incidence of skin cancer and (pre)malignant diagnosis and related healthcare claims will be higher in the intervention group compared to the control group, while the incidence for benign tumor related claims will be lower in the intervention group compared to the control group.
Study design
The first year of the study will be an active comparison phase in which the intervention group will have access to the SVA and the control group will receive the current standard of healthcare. One year after the start of the study the control group will also get access to the SVA for a year. Both groups will enter a passive follow-up phase after one year of using the SVA. In this period, data will be collected on the incidence of skin malignancies, benign skin lesions and pre-malignancies through Palga. Additionally data on claims will be collected from the database of DSW.
Intervention
The intervention group will be offered to use the SkinVision app for free, for a duration of one year. After this year the control group will receive access to the SVA for the period of one year. Both groups will enter a passive follow-up for 2 years after the use of the SVA.
Inclusion criteria
To be eligible to participate in this study, a subject must meet all of the following inclusion criteria:
- Ability to give informed consent for this study.
- ≥ 18 years old.
- Receive health care insurance from DSW.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Persons without an email address.
- Persons without a (compatible) smartphone.
- Persons without an internet connection.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9586 |
| Other | Medisch Ethische Toetsings Commissie Erasmus MC, Rotterdam : MEC-2021-0180 |