Economic Evaluation in Teledermatology

Skin Diseases Clinical Trial

— TELEDERMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378296
• Other study ID #: 27/2020
• Secondary ID: PI_20_12CS Teled
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2022
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 30, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Diseases

Intervention

Other:
• Teledermatology
The experimental group will be made up of dermatological patients monitored asynchronously.

Locations

Country	Name	City	State
Spain	Antonio López-Villegas	El Ejido	Almería
Spain	Hospital de Poniente	El Ejido	Almeria

Sponsors (2)

Lead Sponsor	Collaborator
Antonio Lopez Villegas	Universidad de Almeria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EuroQol-5Dimensions questionnaire	From -1 [the poorest imaginable health state] to 1 [perfect health]	6 months
Secondary	Clinical features	Patient's age; sex; diagnosis; origin; indication (type of dermatological problem); number of visits	6 months
Secondary	Dermatological Quality of Life Questionnaire	0 (no effect on quality of life) up to 100 (maximum effect on quality of life)	6 months
Secondary	Healthcare costs	Costs paid by the Public Health System	6 months
Secondary	Informal cost	Costs paid by the patients	6 months
Secondary	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
Secondary	Health Care Communication Questionnaire	The 5-point Likert scale, ranging from 1 (not at all) to 5 (very much).	6 months