Skin DiseasesTELEDERMANCT04378296
Economic Evaluation in Teledermatology
A study testing Teledermatology in people with Skin Diseases, run by Antonio Lopez Villegas at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases
- What is being tested?
- Teledermatology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Apr 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Be over 18 years old.
- 2. Having any skin disease.
- 3. Accept to participate in the study.
Who cannot join
- 1. Non-dermatological disease.
- 2. Be participating in another study.
- 3. Refuse to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de Poniente
El Ejido, Almeria, 04700
Antonio López-Villegas
El Ejido, Almería, 04700
About this study
Official title: 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).
- Conditions
- Skin Diseases
- Being tested
- Teledermatology
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeledermatologyOther
The experimental group will be made up of dermatological patients monitored asynchronously.
| Study group | Role | What they receive |
|---|---|---|
| Teledermatology | Experimental | The 221 patients who are included in this group will be monitored from the Primary Care centers. Receives: Other: Teledermatology |
| Conventional monitoring | No intervention | The 221 patients included in this group will have to visit the dermatologist at the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EuroQol-5Dimensions questionnaire
From -1 [the poorest imaginable health state] to 1 [perfect health]
Measured: 6 months
Secondary outcomes (6)
Clinical features
Patient's age; sex; diagnosis; origin; indication (type of dermatological problem); number of visits
Measured: 6 months
Dermatological Quality of Life Questionnaire
0 (no effect on quality of life) up to 100 (maximum effect on quality of life)
Measured: 6 months
Healthcare costs
Costs paid by the Public Health System
Measured: 6 months
Informal cost
Costs paid by the patients
Measured: 6 months
In-depth interviews on the healthcare received in Primary Care centers
- healthcare center, 2) procedure to make an appointment, 3) medical consultation, 4) nursing consultation
Measured: 6 months
Health Care Communication Questionnaire
The 5-point Likert scale, ranging from 1 (not at all) to 5 (very much).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Apr 2021
- Primary completion31 Oct 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Lopez Villegas
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Almeria
- Responsible party
- Sponsor-investigator, Antonio Lopez Villegas, Universidad de Almeria
- Investigators
- Antonio Lopez-Villegas, PhD, Principal investigator, Hospital de Poniente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378296
- Sponsor's protocol ID
- 27/2020
- Other IDs
- PI_20_12CS Telederma
- Acronym
- TELEDERMA
- Status last verified
- May 2022
- First submitted
- 4 May 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation in Dermatology: Teledermatology Versus Conventional Monitoring of Patients in the Hospital
- ClinicalTrials.gov ID
- NCT04378296
- Acronym / sponsor ID
- TELEDERMA / 27/2020
- Conditions
- Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Antonio Lopez VillegasUniversity, hospital or other
- Collaborators
- Universidad de Almeria
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teledermatology | Experimental | Other: TeledermatologyThe 221 patients who are included in this group will be monitored from the Primary Care centers. |
| Conventional monitoring | No intervention | –The 221 patients included in this group will have to visit the dermatologist at the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Be over 18 years old.
- 2. Having any skin disease.
- 3. Accept to participate in the study.
Key exclusion criteria (3 listed)
- 1. Non-dermatological disease.
- 2. Be participating in another study.
- 3. Refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeledermatologyThe experimental group will be made up of dermatological patients monitored asynchronously. | Other | Teledermatology |
Primary outcome
EuroQol-5Dimensions questionnaire
Time frame: 6 months
From -1 [the poorest imaginable health state] to 1 [perfect health]
6 secondary outcomes
Clinical features
Time frame: 6 months
Dermatological Quality of Life Questionnaire
Time frame: 6 months
Healthcare costs
Time frame: 6 months
Informal cost
Time frame: 6 months
In-depth interviews on the healthcare received in Primary Care centers
Time frame: 6 months
Health Care Communication Questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Lopez-Villegas, PhD principal investigator
Hospital de Poniente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teledermatology in people with Skin Diseases, run by Antonio Lopez Villegas at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol-5Dimensions questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.