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Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area

Primary Purpose

Skin Cancer, Patient Acceptance of Health Care, Patient Satisfaction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
taking macroscopic and dermoscopic pictures of suspicious skin lesions
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin Cancer focused on measuring Skin Cancer Screening, General Practice, Teledermoscopy, Patient Satisfaction and Acceptance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults ( > 18y)
  • French Speaking Patient

Exclusion Criteria:

  • Illiterate Patients
  • Demented Patients
  • Non-French speaking patients
  • Minors.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patient Acceptance and satisfaction for teledermoscopy

    Arm 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. An 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. The 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.

    Outcomes

    Primary Outcome Measures

    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)
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 17, 2020
    Last Updated
    August 27, 2020
    Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04534868
    Brief Title
    Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area
    Official Title
    Evaluation of Patients Acceptance and Satisfaction With Teledermoscopy at the General Practionner's Office for the Detection of Skin Cancer in a Rural Area.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2020 (Anticipated)
    Primary Completion Date
    February 15, 2021 (Anticipated)
    Study Completion Date
    March 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    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
    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").

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Cancer, Patient Acceptance of Health Care, Patient Satisfaction
    Keywords
    Skin Cancer Screening, General Practice, Teledermoscopy, Patient Satisfaction and Acceptance

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patient Acceptance and satisfaction for teledermoscopy
    Arm Type
    Other
    Arm 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. An 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. The 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.
    Intervention Type
    Other
    Intervention Name(s)
    taking macroscopic and dermoscopic pictures of suspicious skin lesions
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Patient Acceptability Of Teledermoscopy
    Description
    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)
    Time Frame
    20 to 30 minutes to complete the questionnaire.
    Title
    Patient Satisfaction after a teledermoscopy experience
    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
    Time Frame
    15 to 20 minutes (interview duration)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults ( > 18y) French Speaking Patient Exclusion Criteria: Illiterate Patients Demented Patients Non-French speaking patients Minors.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Odile MAGOTTEAUX, Dr
    Phone
    0479177991
    Email
    odile.magotteaux@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Isabelle Tromme, Dr
    Email
    isabelle.tromme@uclouvain.be

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27182461
    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.
    Results Reference
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    30618351
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    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.
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    PubMed Identifier
    20222920
    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.
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    PubMed Identifier
    31438348
    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.
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    32347299
    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.
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    30404081
    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.
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    PubMed Identifier
    32126557
    Citation
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    PubMed Identifier
    30343653
    Citation
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    Citation
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    Links:
    URL
    https://www.agoria.be/fr/Le-coronavirus-active-le-remboursement-de-la-tele-consultation
    Description
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    Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area

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