Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
Study NCT ID:
NCT04534868
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-27', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-27', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Acceptability Of Teledermoscopy', 'timeFrame': '20 to 30 minutes to complete the questionnaire.', 'description': "Using a quantitative survey-type questionnaire\n\n* Determination of the patients ' skin monitoring habits\n* Determination of patients' knowledge of skin cancers and their prevention\n* Determine their acceptance of new technologies such as teledermoscopy in the context of skin cancer screening\n* 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)"}, {'measure': 'Patient Satisfaction after a teledermoscopy experience', 'timeFrame': '15 to 20 minutes (interview duration)', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin Cancer Screening', 'General Practice', 'Teledermoscopy', 'Patient Satisfaction and Acceptance'], 'conditions': ['Skin Cancer', 'Patient Acceptance of Health Care', 'Patient Satisfaction']}, 'referencesModule': {'references': [{'pmid': '27182461', 'type': 'BACKGROUND', '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. doi: 10.1007/s13671-016-0136-7. Epub 2016 Mar 28.'}, {'pmid': '30618351', 'type': 'BACKGROUND', '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.'}, {'pmid': '20222920', 'type': 'BACKGROUND', '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.'}, {'pmid': '24923283', 'type': 'BACKGROUND', 'citation': 'Borve A, Dahlen 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.'}, {'pmid': '31438348', 'type': 'BACKGROUND', '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.'}, {'pmid': '32347299', 'type': 'BACKGROUND', '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 Sep 5;37(4):513-518. doi: 10.1093/fampra/cmaa041.'}, {'pmid': '30404081', 'type': 'BACKGROUND', '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.'}, {'pmid': '32126557', 'type': 'BACKGROUND', '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."}, {'pmid': '30343653', 'type': 'BACKGROUND', '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.'}, {'pmid': '26568080', 'type': 'BACKGROUND', '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, Cremieux 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."}, {'pmid': '31833275', 'type': 'BACKGROUND', '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.'}, {'pmid': '32179927', 'type': 'BACKGROUND', '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.'}, {'pmid': '28350281', 'type': 'BACKGROUND', '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.'}, {'pmid': '28775188', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'https://www.agoria.be/fr/Le-coronavirus-active-le-remboursement-de-la-tele-consultation', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* To identify patients\' knowledge of skin cancers, their skin monitoring habits, and their acceptability of new telemedicine tools such as teledermoscopy ("Part 1").\n* To evaluate the satisfaction and expectations of those who benefit from teledermoscopy ("Part 2").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ( \\> 18y)\n* French Speaking Patient\n\nExclusion Criteria:\n\n* Illiterate Patients\n* Demented Patients\n* Non-French speaking patients\n* Minors.'}, 'identificationModule': {'nctId': 'NCT04534868', 'briefTitle': 'Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': "Evaluation of Patients Acceptance and Satisfaction With Teledermoscopy at the General Practionner's Office for the Detection of Skin Cancer in a Rural Area.", 'orgStudyIdInfo': {'id': 'CE 2020/06AOU/397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient Acceptance and satisfaction for teledermoscopy', 'description': "The aim of the first part of the study is to evaluate patients' skin monitoring habits, their knowledge of skin cancer, and their preconceptions about new telemedicine tools such as teledermoscopy. This is a written quantitative questionnaire with answers to tick.\n\nAn explanatory folder will be given to patients and they will be asked to read it beforehand in order to allow a good understanding of the terms used and the goal of the project. This part will include 70 to 100 patients.\n\nThe second part of the study is a qualitative study and the aim of it is to evaluate the satisfaction, acceptance and future expectations of those who have benefited from teledermoscopy. Individual and anonymous interviews, lasting 15 to 20 minutes, intended for patients who have benefit of teledermoscopy at the office. An explanatory folder will also be given to the patients concerned in order to explain to them the procedure of the interview. This part will include 8 to 10 patients.", 'interventionNames': ['Other: taking macroscopic and dermoscopic pictures of suspicious skin lesions']}], 'interventions': [{'name': 'taking macroscopic and dermoscopic pictures of suspicious skin lesions', 'type': 'OTHER', 'description': 'If there is any diagnostic doubt about a skin lesion, teledermoscopy will be used, if the patient agrees.\n\n* A table containing the useful information about the patient for the lesion\'s analysis will be completed.\n* The pictures will be taken with a Fotofinder Handyscope. The photos will be integrated into the patient\'s electronic medical record (CareConnect program).\n* The photo is anonymized via a serial number assigned by the "Handyscope" application.\n* Sending photos and information via a secure email address to the dermatologists.\n* Response from the dermatologist (Prof. Tromme or Dr Harkemanne) in the following days also via email.\n* Contact (consultation or telephone call depending on the diagnosis) with the patient to communicate the results and the procedure to be followed.\n* This information (emails containing the dermatological report) will be saved in the patient\'s computerized medical file (CareConnect program) then deleted from the mailbox', 'armGroupLabels': ['Patient Acceptance and satisfaction for teledermoscopy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Odile MAGOTTEAUX, Dr', 'role': 'CONTACT', 'email': 'odile.magotteaux@hotmail.com', 'phone': '0479177991'}, {'name': 'Isabelle Tromme, Dr', 'role': 'CONTACT', 'email': 'isabelle.tromme@uclouvain.be'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}