Economic Evaluation in Teledermatology (TELEDERMA)

Economic Evaluation in Dermatology: Teledermatology Versus Conventional Monitoring of Patients in the Hospital

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).

Study Overview

• Status: Completed
• Conditions: Skin Diseases
• Intervention / Treatment: Other: Teledermatology

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Almeria
    • El Ejido, Almeria, Spain, 04700
      • Hospital de Poniente
  • Almería
    • El Ejido, Almería, Spain, 04700
      • Antonio López-Villegas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teledermatology; The 221 patients who are included in this group will be monitored from the Primary Care centers.	Other: Teledermatology; The experimental group will be made up of dermatological patients monitored asynchronously.
No Intervention: Conventional monitoring; The 221 patients included in this group will have to visit the dermatologist at the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol-5Dimensions questionnaire	From -1 [the poorest imaginable health state] to 1 [perfect health]	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Antonio Lopez Villegas
• Collaborators: Universidad de Almeria
• Investigators: Principal Investigator: Antonio Lopez-Villegas, PhD, Hospital de Poniente

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 27/2020; PI_20_12CS Telederma (Registry Identifier: Hospital de Poniente)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No