Economic Evaluation in Teledermatology (TELEDERMA)

Antonio Lopez Villegas

Status: Completed

Conditions: Skin Diseases

Treatments: Other: Teledermatology

Study type: Interventional

Funder types: Other

Identifiers

NCT04378296

PI_20_12CS Telederma (Registry Identifier)

27/2020

Details and patient eligibility

About

Introduction: Previous studies confirm that teledermatology allows the generation of a quick response from the specialist's consultation, reduction of unnecessary travels, early diagnosis and priority in the attention to the most urgent cases. Despite these advantages and that teledermatology has experienced exponential growth since its introduction approximately 16 years ago in Spain, in Andalusia, its use is still very limited. The objective of this project will be to carry out an analysis of the quality of life related to health, costs, cost-utility and informal care of teledermatology services in Primary Care compared to conventional monitoring carried out at the Hospital de Poniente.

Methodology: A randomized, controlled, unmasked, inter-level clinical trial (Primary Care-Hospital de Poniente) and multicentre (all health centers attached to the Poniente Health District of Almería) will be carried out with a 6-month follow-up. Patients will be assigned to the teledermatology group (experimental) or the conventional monitoring group in the hospital (control). The patients included in the experimental group will be monitored asynchronously. Baseline characteristics, number of visits to the hospital, health-related quality of life, costs, informal care and satisfaction from the perspective of the Andalusian Public Health System and patients and their caregivers will be analyzed. The generic EuroQol-5D questionnaire (EQ-5D) will be administered to assess health-related quality of life and the SKINDEX-29 quality of life dermatological questionnaire. A cost-utility analysis will be performed to assess whether tele-dermatology is cost-effective in terms of additional cost for additional quality-adjusted life years (QALYs).

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Be over 18 years old.
• 2. Having any skin disease.
• 3. Accept to participate in the study.

Exclusion criteria

• 1. Non-dermatological disease.
• 2. Be participating in another study.
• 3. Refuse to participate in the study.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 2 patient groups

Teledermatology

Experimental group

Description:

The 221 patients who are included in this group will be monitored from the Primary Care centers.

Treatment:

Other: Teledermatology

Conventional monitoring

No Intervention group

Description:

The 221 patients included in this group will have to visit the dermatologist at the hospital.