Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne
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|ClinicalTrials.gov Identifier: NCT04593004|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Acne vulgaris is a common cutaneous inflammatory condition of sebaceous follicles that can profoundly affect patients' quality of life, especially at a young age. In this context the use of teledermatology can potentially reduce the healthcare costs associated to traditional consultations as well as the costs related to travel and loss of school/working time for the patient, with a clear benefit for the whole community. Since 2016, the Department of Dermatology at Inselspital Hospital in Bern has a portal and a smartphone app for online advice service.
Hereby the investigators propose to explicitly investigate the efficacy of this system in reducing healthcare costs as compared to traditional face-to-face consultations, in a cohort of patients with mild-to-moderate acne vulgaris.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Device: Teledermatology Other: Face-to-face consultation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||1:1 stratified random allocation|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Randomized Open-Label Trial Comparing Teledermatology vs. Face-to-Face Consultation in the Follow-Up of Patients With Mild-to-Moderate Acne|
|Actual Study Start Date :||October 8, 2020|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
Patients will be assessed and followed-up by trained physicians through a store-and-forward system (teledermatology online service - Evita® app), which allows patients to upload pictures of skin areas affected by acne as well as their symptoms or questions related to their disease.
|Active Comparator: Face-to-face consultation||
Other: Face-to-face consultation
Patients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations.
- Total time spent by dermatologist after baseline [ Time Frame: 4 months ]Total cumulative time spent by dermatologist for face-to-face consultations or online assessments after baseline.
- Total time spent by patient after baseline [ Time Frame: 4 months ]Total cumulative time spent by patient for visit-related travels and/or online procedures after baseline.
- Acne severity improvement [ Time Frame: 2, 4 and 6 months ]Acne severity improvement from baseline as assessed by 5-point ordinal investigator's global assessment (IGA) scale, ranging from 1 to 5, with higher scores indicating a worse outcome.
- Number of therapies prescribed for acne [ Time Frame: 2, 4 and 6 months ]
- Patient study satisfaction [ Time Frame: 6 months ]Overall patient satisfaction regarding the service received during the study as assessed by 11-point anchored visual analogue scale (VAS), ranging from 0 to 10, with higher scores indicating a better outcome.
- Patient quality of life improvement [ Time Frame: 6 months ]Patient quality of life improvement from baseline as assessed by dermatology life quality index (DLQI), ranging from 0 to 30, with higher scores indicating a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593004
|Contact: Kristine Heidemeyer, MD||316322218 ext +41||Kristine.Heidemeyer@insel.ch|
|Department of dermatology, University Hospital Inselspital, Bern||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Kristine Heidemeyer, MD 316322218 ext +41 Kristine.Heidemeyer@insel.ch|
|Principal Investigator:||Robert Hunger, MD||University Hospital Inselspital, Bern|