Economic Evaluation in Teledermatology

NCT ID: NCT04378296

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-04-30

Brief Summary

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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

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Conditions

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Skin Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Teledermatology

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

Group Type EXPERIMENTAL

Teledermatology

Intervention Type OTHER

The experimental group will be made up of dermatological patients monitored asynchronously.

Conventional monitoring

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Teledermatology

The experimental group will be made up of dermatological patients monitored asynchronously.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Almeria

OTHER

Sponsor Role collaborator

Antonio Lopez Villegas

OTHER

Sponsor Role lead

Responsible Party

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Antonio Lopez Villegas

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Antonio Lopez-Villegas, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Poniente

Locations

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Hospital de Poniente

El Ejido, Almeria, Spain

Site Status

Antonio López-Villegas

El Ejido, Almería, Spain

Site Status

Countries

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Spain

Other Identifiers

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PI_20_12CS Telederma

Identifier Type: REGISTRY

Identifier Source: secondary_id

27/2020

Identifier Type: -

Identifier Source: org_study_id

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