Clinical trial NCT04378296: Economic Evaluation in Teledermatology
Official title: Economic Evaluation in Dermatology: Teledermatology Versus Conventional Monitoring of Patients in the Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Diseases
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Universidad de Almeria
First posted: 2020-05-07
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: EuroQol-5Dimensions questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Clinical features
timeFrame: 6 months
measure: Dermatological Quality of Life Questionnaire
timeFrame: 6 months
measure: Healthcare costs
timeFrame: 6 months
measure: Informal cost
timeFrame: 6 months
measure: In-depth interviews on the healthcare received in Primary Care centers
timeFrame: 6 months
measure: Health Care Communication Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: El Ejido
country: Spain
facility: Hospital de Poniente
state: Almeria
city: El Ejido
country: Spain
facility: Antonio López-Villegas
state: Almería
Study officials:
affiliation: Hospital de Poniente
name: Antonio Lopez-Villegas, PhD
role: PRINCIPAL_INVESTIGATOR
References: