TeledermatologyTeleDermaSANCT05625295
Tele-dermatology Non-presential (TeleDermaSA)
An observational study of Teledermatology and Primary Care, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
The purpose of the study is to evaluate the implementation of the Non-Face-to-Face Interconsultation of dermatology since it began to be used in August 2020 until August 2022 in the province of Salamanca (Spain) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Teledermatology, Primary Care
- What is being tested?
- data collection protocol in clinical history
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2022to 1 Jul 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: The unit of analysis will be the PNCIs performed in dermatology from Primary Care, registered in Medora software, with its corresponding photographic file, and its response in Jimena software of the dermatology service, from June 2021 to June 2022, one year. A random sample stratified by type of center (urban, semi-urban and rural) will be extracted. A control group of face-to-face consultations will be used, in a similar number (500) obtained randomly, and also stratified by type of center, which will be used to compare the information from the NCIs.
Who may be able to join
- The unit of analysis will be the PNCIs performed in dermatology from Primary Care, registered in Medora software, with its corresponding photographic file, and its response in Jimena software of the dermatology service, from June 2021 to June 2022, one year.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Implementation of Tele-dermatology, in Its Modality of Non-presential Inter-consultation, in the Province of Salamanca.
The purpose of the study is to evaluate the implementation of the Non-Face-to-Face Interconsultation of dermatology since it began to be used in August 2020 until August 2022 in the province of Salamanca (Spain)
Read the detailed description
Design: cross-sectional descriptive study. Subjects: The unit of analysis will be the NPIs performed in dermatology since its implementation in August 2020 until the present time in the health area of Salamanca. To analyze the face-to-face consultations to analyze the differences. A random sample of 500 PNCIs and 500 face-to-face consultations will be extracted.
Measurements: To analyze the ICNP and face-to-face IC to dermatology registered in the computerized clinical history made in PC from Medora and registered in Jimena. To record the number of consultations, type of pathology referred, dermatology response time, discharges after assessment, face-to-face consultations required, delay time, treatment required, follow-up required or not, diagnostic coincidence, quality of the photographic image sent.
A differentiated analysis will be made according to the use or not of the dermatoscope, type of center (urban, semi-urban and rural), gender of the patients and age groups.
- Conditions
- Teledermatology, Primary Care
- Being tested
- data collection protocol in clinical history
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection protocol in clinical historyOther
collection of data from the clinical history according to the established protocol
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-face-to-face consultation | A sample of 500 patients who have undergone non-face-to-face consultation with dermatology Receives: Other: data collection protocol in clinical history | |
| Patients with face-to-face consultation | A sample of 500 patients who have undergone face-to-face consultation with dermatology Receives: Other: data collection protocol in clinical history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Derivation rates per 10,000 h.
number of patients referred to the dermatology office
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TeledermatologyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Garcia Ortiz, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Investigators
- Luis G Garcia Ortiz, PhD, Study director, FUNDACION INFOSALUD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625295
- Sponsor's protocol ID
- 116
- Acronym
- TeleDermaSA
- Status last verified
- Jul 2023
- First submitted
- 13 Nov 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanchez-Martin E, Moreno-Sanchez I, Moran-Sanchez M, Perez-Martin M, Martin-Morales M, Garcia-Ortiz L. Store-and-forward teledermatology in a Spanish health area significantly increases access to dermatology expertise. BMC Prim Care. 2024 Jun 24;25(1):227. doi: 10.1186/s12875-024-02479-1.
PubMed 38914974
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of Tele-dermatology, in Its Modality of Non-presential Inter-consultation, in the Province of Salamanca.
- ClinicalTrials.gov ID
- NCT05625295
- Acronym / sponsor ID
- TeleDermaSA / 116
- Conditions
- Teledermatology, Primary Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 22 Nov 2022 (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.
The purpose of the study is to evaluate the implementation of the Non-Face-to-Face Interconsultation of dermatology since it began to be used in August 2020 until August 2022 in the province of Salamanca (Spain)
Detailed description
Design: cross-sectional descriptive study. Subjects: The unit of analysis will be the NPIs performed in dermatology since its implementation in August 2020 until the present time in the health area of Salamanca. To analyze the face-to-face consultations to analyze the differences. A random sample of 500 PNCIs and 500 face-to-face consultations will be extracted.
Measurements: To analyze the ICNP and face-to-face IC to dermatology registered in the computerized clinical history made in PC from Medora and registered in Jimena. To record the number of consultations, type of pathology referred, dermatology response time, discharges after assessment, face-to-face consultations required, delay time, treatment required, follow-up required or not, diagnostic coincidence, quality of the photographic image sent.
A differentiated analysis will be made according to the use or not of the dermatoscope, type of center (urban, semi-urban and rural), gender of the patients and age groups.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with non-face-to-face consultation | – | Other: data collection protocol in clinical historyA sample of 500 patients who have undergone non-face-to-face consultation with dermatology |
| Patients with face-to-face consultation | – | Other: data collection protocol in clinical historyA sample of 500 patients who have undergone face-to-face consultation with dermatology |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The unit of analysis will be the PNCIs performed in dermatology from Primary Care, registered in Medora software, with its corresponding photographic file, and its response in Jimena software of the dermatology service, from June 2021 to June 2022, one year. A random sample stratified by type of center (urban, semi-urban and rural) will be extracted. A control group of face-to-face consultations will be used, in a similar number (500) obtained randomly, and also stratified by type of center, which will be used to compare the information from the NCIs.
Key inclusion criteria (1 listed)
- The unit of analysis will be the PNCIs performed in dermatology from Primary Care, registered in Medora software, with its corresponding photographic file, and its response in Jimena software of the dermatology service, from June 2021 to June 2022, one year.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| data collection protocol in clinical historycollection of data from the clinical history according to the established protocol | Other | Patients with face-to-face consultation, Patients with non-face-to-face consultation |
Primary outcome
Derivation rates per 10,000 h.
Time frame: 1 year
number of patients referred to the dermatology office
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 20 Jul 2023.
- Derived from this study: PubMed 38914974Sanchez-Martin E, Moreno-Sanchez I, Moran-Sanchez M, Perez-Martin M, Martin-Morales M, Garcia-Ortiz L. Store-and-forward teledermatology in a Spanish health area significantly increases access to dermatology expertise. BMC Prim Care. 2024 Jun 24;25(1):227. doi: 10.1186/s12875-024-02479-1.
- Individual participant dataSharing planned: Undecided
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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.
Luis G Garcia Ortiz, PhD study director
FUNDACION INFOSALUD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Teledermatology and Primary Care, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site 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 1 inclusion and 1 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 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Derivation rates per 10,000 h. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05625295, which also lists 1 linked publication.
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 20 Jul 2023.