Economic Evaluation in Teledermatology

Not Applicable

Completed

• Conditions: Skin Diseases
• Interventions: Other: Teledermatology

• Registration Number: NCT04378296
• Lead Sponsor: Antonio Lopez Villegas

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-07
• Study Start: 2021-04-01
• Primary Completion: 2021-10-31
• Study Completion: 2022-04-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
EuroQol-5Dimensions questionnaire	6 months	From -1 \[the poorest imaginable health state\] to 1 \[perfect health\]

Secondary Outcome Measures

Name	Time	Method
Healthcare costs	6 months	Costs paid by the Public Health System
Informal cost	6 months	Costs paid by the patients
Clinical features	6 months	Patient's age; sex; diagnosis; origin; indication (type of dermatological problem); number of visits
In-depth interviews on the healthcare received in Primary Care centers	6 months	1) healthcare center, 2) procedure to make an appointment, 3) medical consultation, 4) nursing consultation
Dermatological Quality of Life Questionnaire	6 months	0 (no effect on quality of life) up to 100 (maximum effect on quality of life)
Health Care Communication Questionnaire	6 months	The 5-point Likert scale, ranging from 1 (not at all) to 5 (very much).

Trial Locations

Locations (2)

Hospital de Poniente; 🇪🇸 El Ejido, Almeria, Spain

Antonio López-Villegas; 🇪🇸 El Ejido, Almería, Spain