Economic Evaluation in Teledermatology (TELEDERMA)
Primary Purpose
Skin Diseases
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Teledermatology
Sponsored by
About this trial
This is an interventional health services research trial for Skin Diseases
Eligibility Criteria
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.
Sites / Locations
- Hospital de Poniente
- Antonio López-Villegas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Teledermatology
Conventional monitoring
Arm Description
The 221 patients who are included in this group will be monitored from the Primary Care centers.
The 221 patients included in this group will have to visit the dermatologist at the hospital.
Outcomes
Primary Outcome Measures
EuroQol-5Dimensions questionnaire
From -1 [the poorest imaginable health state] to 1 [perfect health]
Secondary Outcome Measures
Clinical features
Patient's age; sex; diagnosis; origin; indication (type of dermatological problem); number of visits
Dermatological Quality of Life Questionnaire
0 (no effect on quality of life) up to 100 (maximum effect on quality of life)
Healthcare costs
Costs paid by the Public Health System
Informal cost
Costs paid by the patients
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
Health Care Communication Questionnaire
The 5-point Likert scale, ranging from 1 (not at all) to 5 (very much).
Full Information
NCT ID
NCT04378296
First Posted
May 4, 2020
Last Updated
May 17, 2022
Sponsor
Antonio Lopez Villegas
Collaborators
Universidad de Almeria
1. Study Identification
Unique Protocol Identification Number
NCT04378296
Brief Title
Economic Evaluation in Teledermatology
Acronym
TELEDERMA
Official Title
Economic Evaluation in Dermatology: Teledermatology Versus Conventional Monitoring of Patients in the Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Antonio Lopez Villegas
Collaborators
Universidad de Almeria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teledermatology
Arm Type
Experimental
Arm Description
The 221 patients who are included in this group will be monitored from the Primary Care centers.
Arm Title
Conventional monitoring
Arm Type
No Intervention
Arm Description
The 221 patients included in this group will have to visit the dermatologist at the hospital.
Intervention Type
Other
Intervention Name(s)
Teledermatology
Intervention Description
The experimental group will be made up of dermatological patients monitored asynchronously.
Primary Outcome Measure Information:
Title
EuroQol-5Dimensions questionnaire
Description
From -1 [the poorest imaginable health state] to 1 [perfect health]
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical features
Description
Patient's age; sex; diagnosis; origin; indication (type of dermatological problem); number of visits
Time Frame
6 months
Title
Dermatological Quality of Life Questionnaire
Description
0 (no effect on quality of life) up to 100 (maximum effect on quality of life)
Time Frame
6 months
Title
Healthcare costs
Description
Costs paid by the Public Health System
Time Frame
6 months
Title
Informal cost
Description
Costs paid by the patients
Time Frame
6 months
Title
In-depth interviews on the healthcare received in Primary Care centers
Description
1) healthcare center, 2) procedure to make an appointment, 3) medical consultation, 4) nursing consultation
Time Frame
6 months
Title
Health Care Communication Questionnaire
Description
The 5-point Likert scale, ranging from 1 (not at all) to 5 (very much).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Lopez-Villegas, PhD
Organizational Affiliation
Hospital de Poniente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Poniente
City
El Ejido
State/Province
Almeria
ZIP/Postal Code
04700
Country
Spain
Facility Name
Antonio López-Villegas
City
El Ejido
State/Province
Almería
ZIP/Postal Code
04700
Country
Spain
12. IPD Sharing Statement
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Economic Evaluation in Teledermatology
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