Study Design
itching, itch, NRS, pain
DISEASE, PATHOGENESIS, SECONDARY, FOOT ECZEMA
The aim of this 60-week randomized controlled intervention study was to investigate the effect of patient education in combination with a monitoring smartphone app on patients experiencing chronic hand and foot eczema. This is an interim analysis of the data from study weeks 0, 12, and 24.The study was carried out at the department of dermatology, venereology, and allergology at the University Medical Center Mannheim in Mannheim, Germany, from August 13, 2018, to August 30, 2021. The inclusion criteria included a physician-confirmed diagnosis of chronic hand and foot eczema, ability to give informed consent, access to a smartphone, and patient age between 18 and 75 years. During the first study visit (week 0 [V1]), the study participants were randomly assigned to the control or intervention group in a ratio of 1:1.To assign patients to a group, we created 50 lots for the intervention group and 50 lots for the control group. These were sealed in an urn, and the patients were asked to draw lots.In total, 90 participants were included in the study, but 3 (3%) dropped out of the study before they were assigned to a group. Of the 87 remaining participants, 43 (49%) were assigned to the intervention group and 44 (51%) to the control group.The control group started the first study visit at week 0. Information on sociodemographic data, preexisting conditions, and previous and current therapies were collected, and standardized questionnaires such as the DLQI administered. In addition, patients’ current level of knowledge about their disease, severity of the disease measured using the HECSI or a modified form of the HECSI for foot eczema, and the intensity of the pain and itch measured using an NRS ranging from 0 to 10 were recorded. Furthermore, the negative impact on the activity measured using the NRS of patients was assessed. In-person follow-up visits were carried out at V2 and V3. The same parameters were recorded for the intervention group. In addition, these patients received a 2-hour detailed training session on pathogenesis, classification, therapeutic options, and behavioral recommendations from 2 dermatological specialists at our clinic. Each patient also received a personal access code to our app, DermaScope Mobile. Using this app, patients were able to take pictures of their hands and feet, use a chat function to ask questions that were answered by their treating dermatologists, and complete questionnaires on quality of life (DLQI) and current symptoms (NRS for itch and pain). Screenshots of the app can be found in the paper by Domogalla et al [The quality of each image uploaded in the app by the patients was categorized by the rater (YS) as good or bad based on the following criteria: well-illuminated picture, sharp and focused image, and complete presentation of the hands and feet. All 3 criteria had to be met for the image to be rated as good. Each image was assigned to the rater (YS), who checked its quality based on these 3 criteria. If all criteria were met, the image was rated as of good quality. We then calculated an electronic HECSI (eHECSI) score based on these images and statistically examined the extent to which this score correlated with the HECSI score collected in person.The primary end point of the study was to determine the effect of extensive patient training, physician-patient contact on demand, and our app on quality of life as well as itching and pain at weeks 12 and 24. The secondary end points were the effect on the disease outcome assessed with the HECSI at weeks 12 and 24. Modulating effects of sex, age, and disease duration were evaluated for each end point.