NCT04378296

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

May 4, 2020

Last Update Submit

May 17, 2022

Conditions

Skin Diseases

Outcome Measures

Primary Outcomes (1)

  • EuroQol-5Dimensions questionnaire

    From -1 \[the poorest imaginable health state\] to 1 \[perfect health\]

    6 months

Secondary Outcomes (6)

  • Clinical features

    6 months

  • Dermatological Quality of Life Questionnaire

    6 months

  • Healthcare costs

    6 months

  • Informal cost

    6 months

  • In-depth interviews on the healthcare received in Primary Care centers

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Teledermatology

EXPERIMENTAL

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

Other: Teledermatology

Conventional monitoring

NO INTERVENTION

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

Interventions

TeledermatologyOTHER

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

Teledermatology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Be over 18 years old.
  • \. Having any skin disease.
  • \. Accept to participate in the study.

You may not qualify if:

  • \. Non-dermatological disease.
  • \. Be participating in another study.
  • \. Refuse to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Poniente

El Ejido, Almeria, 04700, Spain

Location

Antonio López-Villegas

El Ejido, Almería, 04700, Spain

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

  • Antonio Lopez-Villegas, PhD

    Hospital de Poniente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

April 1, 2021

Primary Completion

October 31, 2021

Study Completion

April 30, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations

ES(2)