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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04534868
Other study ID # CE 2020/06AOU/397
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 15, 2020
Est. completion date March 15, 2021

Study information

Verified date August 2020
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Odile MAGOTTEAUX, Dr
Phone 0479177991
Email odile.magotteaux@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim objective of this work is to assess the characteristics of patients for whom teledermoscopy could be suitable for the detection of potential skin cancers, within a population of rural general medicine in the South of Hainaut, by means of a mixed quantitative and qualitative study corresponding respectively:

- To identify patients' knowledge of skin cancers, their skin monitoring habits, and their acceptability of new telemedicine tools such as teledermoscopy ("Part 1").

- To evaluate the satisfaction and expectations of those who benefit from teledermoscopy ("Part 2").


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 15, 2021
Est. primary completion date February 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults ( > 18y)

- French Speaking Patient

Exclusion Criteria:

- Illiterate Patients

- Demented Patients

- Non-French speaking patients

- Minors.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
taking macroscopic and dermoscopic pictures of suspicious skin lesions
If there is any diagnostic doubt about a skin lesion, teledermoscopy will be used, if the patient agrees. A table containing the useful information about the patient for the lesion's analysis will be completed. The pictures will be taken with a Fotofinder Handyscope. The photos will be integrated into the patient's electronic medical record (CareConnect program). The photo is anonymized via a serial number assigned by the "Handyscope" application. Sending photos and information via a secure email address to the dermatologists. Response from the dermatologist (Prof. Tromme or Dr Harkemanne) in the following days also via email. Contact (consultation or telephone call depending on the diagnosis) with the patient to communicate the results and the procedure to be followed. This information (emails containing the dermatological report) will be saved in the patient's computerized medical file (CareConnect program) then deleted from the mailbox

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

References & Publications (14)

Börve A, Dahlén Gyllencreutz J, Terstappen K, Johansson Backman E, Aldenbratt A, Danielsson M, Gillstedt M, Sandberg C, Paoli J. Smartphone teledermoscopy referrals: a novel process for improved triage of skin cancer patients. Acta Derm Venereol. 2015 Feb;95(2):186-90. doi: 10.2340/00015555-1906. — View Citation

Damsin T, Jacquemin P, Canivet G, Giet D, Gillet P, Nikkels AF. [TeleSPOT Project : early detection of melanoma by teledermoscopy in general practice]. Rev Med Liege. 2019 Dec;74(12):650-654. French. — View Citation

Gilling S, Mortz CG, Vestergaard T. Patient Satisfaction and Expectations Regarding Mobile Teledermoscopy in General Practice for Diagnosis of Non-melanoma Skin Cancer and Malignant Melanoma. Acta Derm Venereol. 2020 Apr 21;100(8):adv00117. doi: 10.2340/00015555-3459. — View Citation

Hue L, Makhloufi S, Sall N'Diaye P, Blanchet-Bardon C, Sulimovic L, Pomykala F, Colomb M, Baccard M, Lassau F, Reuter G, Keller F, Fite C, Triller R, Crémieux AC. Real-time mobile teledermoscopy for skin cancer screening targeting an agricultural population: an experiment on 289 patients in France. J Eur Acad Dermatol Venereol. 2016 Jan;30(1):20-4. doi: 10.1111/jdv.13404. Epub 2015 Nov 16. — View Citation

Kips J, Lambert J, Ongenae K, De Sutter A, Verhaeghe E. Teledermatology in Belgium: a pilot study. Acta Clin Belg. 2020 Apr;75(2):116-122. doi: 10.1080/17843286.2018.1561812. Epub 2019 Jan 8. — View Citation

Koh U, Horsham C, Soyer HP, Loescher LJ, Gillespie N, Vagenas D, Janda M. Consumer Acceptance and Expectations of a Mobile Health Application to Photograph Skin Lesions for Early Detection of Melanoma. Dermatology. 2019;235(1):4-10. doi: 10.1159/000493728. Epub 2018 Nov 7. — View Citation

Kong F, Horsham C, Rayner J, Simunovic M, O'Hara M, Soyer HP, Janda M. Consumer Preferences for Skin Cancer Screening Using Mobile Teledermoscopy: A Qualitative Study. Dermatology. 2020;236(2):97-104. doi: 10.1159/000505620. Epub 2020 Mar 3. — View Citation

Kruse CS, Krowski N, Rodriguez B, Tran L, Vela J, Brooks M. Telehealth and patient satisfaction: a systematic review and narrative analysis. BMJ Open. 2017 Aug 3;7(8):e016242. doi: 10.1136/bmjopen-2017-016242. Review. — View Citation

Mounessa JS, Chapman S, Braunberger T, Qin R, Lipoff JB, Dellavalle RP, Dunnick CA. A systematic review of satisfaction with teledermatology. J Telemed Telecare. 2018 May;24(4):263-270. doi: 10.1177/1357633X17696587. Epub 2017 Mar 28. Review. — View Citation

Snoswell CL, Whitty JA, Caffery LJ, Loescher LJ, Gillespie N, Janda M. Direct-to-consumer mobile teledermoscopy for skin cancer screening: Preliminary results demonstrating willingness-to-pay in Australia. J Telemed Telecare. 2018 Dec;24(10):683-689. doi: 10.1177/1357633X18799582. — View Citation

Tan E, Yung A, Jameson M, Oakley A, Rademaker M. Successful triage of patients referred to a skin lesion clinic using teledermoscopy (IMAGE IT trial). Br J Dermatol. 2010 Apr;162(4):803-11. doi: 10.1111/j.1365-2133.2010.09673.x. Epub 2010 Mar 5. — View Citation

Tensen E, van der Heijden JP, Jaspers MW, Witkamp L. Two Decades of Teledermatology: Current Status and Integration in National Healthcare Systems. Curr Dermatol Rep. 2016;5:96-104. Epub 2016 Mar 28. Review. — View Citation

van Sinderen F, Tensen E, van der Heijden JP, Witkamp L, Jaspers MWM, Peute LWP. Is Teledermoscopy Improving General Practitioner Skin Cancer Care? Stud Health Technol Inform. 2019 Aug 21;264:1795-1796. doi: 10.3233/SHTI190652. — View Citation

Vestergaard T, Prasad SC, Schuster A, Laurinaviciene R, Bygum A, Munck A, Andersen MK. Introducing teledermoscopy of possible skin cancers in general practice in Southern Denmark. Fam Pract. 2020 Apr 29. pii: cmaa041. doi: 10.1093/fampra/cmaa041. [Epub ahead of print] — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Acceptability Of Teledermoscopy Using a quantitative survey-type questionnaire
Determination of the patients ' skin monitoring habits
Determination of patients' knowledge of skin cancers and their prevention
Determine their acceptance of new technologies such as teledermoscopy in the context of skin cancer screening
And finally, determination of a target population for whom teledermoscopy could be suitable for the detection of skin cancers (percentage of patients accepting teledermoscopy etc)
20 to 30 minutes to complete the questionnaire.
Primary Patient Satisfaction after a teledermoscopy experience Assessment of the satisfaction and future expectations of patients who have benefited from teledermoscopy in general practice, using a qualitative study in the form of semi-structured, individual and anonymous interviews 15 to 20 minutes (interview duration)
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