Back to resultsPilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform (AMEDOP)
Primary Purpose
Thyroid
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
access to the internet information platform
Sponsored by
About this trial
This is an interventional supportive care trial for Thyroid focused on measuring Preoperative Procedure, Instructional Films and Video
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 75,
- Indication of lobo-isthmectomy or total thyroidectomy
- Compliance for the completion of self-questionnaires
- Person affiliated or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
- Difficulty understanding the French language
- Lack of internet access
- Persons placed under the protection of justice,
- Person under guardianship or curatorship
- Person participating in another research including an exclusion period still in progress,
- Subject with severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant
- Pregnant / lactating woman
Sites / Locations
- CHU Gui de ChauliacRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
access to the internet information platform
usual preoperative information
Arm Description
usual preoperative information and access to the internet information platform
medical information delivered to the patient before any surgery
Outcomes
Primary Outcome Measures
Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE
rate of patients with perioperative anxiety symptoms refind by APAIS SCORE >= 11.
Rate from 1 (absent) to 5 (extrem). Score 2 to 4 : rejection of information, 5 to 7 : medium desire for information, > 7 : hungry for information.
Secondary Outcome Measures
State-Trait Anxiety Inventory (STAI-ETAT) SCORE
overall anxiety score. 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety.
Internet use self-questionnaire
Description of internet use and median number of internet use during the preoperative period collected using the follow-up book given to the patient during the inclusion visit.
4 items, if the answer for the 1st item is YES (Do you regulary consult the Internet for your health?) the subject must complete the item 2 and 4. If it's NO the subject must complete only the item 3.
Item 2 is "why are you consulting internet" the subject had 3 possibility multiple choice questionnaire by answering with yes or no.
Item 3 "Why the subject Don't use internet" 3 possibility multiple choice questionnaire by answering with yes or no.
Item 4 "utility of the information found on internet" rate from 1 (none) to 5 (very important).
Internet use self-questionnaire
Description of internet use and median number of internet use during the preoperative period collected using the follow-up book given to the patient during post opérative visit.
4 items, if the answer for the 1st item is YES (Do you regulary consult the Internet for your health?) the subject must complete the item 2 and 4. If it's NO the subject must complete only the item 3.
Item 2 is "why are you consulting internet" the subject had 3 possibility multiple choice questionnaire by answering with yes or no.
Item 3 "Why the subject Don't use internet" 3 possibility multiple choice questionnaire by answering with yes or no.
Item 4 "utility of the information found on internet" rate from 1 (none) to 5 (very important).
specific questionnaire EDOP
specific questionnaire in experimental group on the internet platform. 6 Items. Items 1, 2, 3, 6 in the form of a 5-response Likert scale (from 1: not satisfied at all, to 5 very satisfied).
Item 4 number of times the platform is consulted. Item 5 is if the subject had consulted other website after consulting EDOP platform. If yes how many times, and the name(s) of the website, why did you consult website.
satisfaction assessment questionnaire and understanding of the preoperative medical information for control group
Level of satisfaction and understanding obtained on the satisfaction assessment questionnaire and understanding of the preoperative medical information received for the control group.
4 Items. Item 1 "quality of information" : 2 questions clear information and understanding in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally).
Item 2 necessity of complementary information, choice between no, a few, many information.
Item 3 "comprehension on different topics explained by the physician conserning the surgery. This item is devided in 6 questions in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally).
Item 4 Visual analog scale rate from 0 not satisfied at all, to 100 totally satisfied.
satisfaction assessment questionnaire and understanding of the preoperative medical information for experimental groupe
Level of satisfaction and understanding obtained on the satisfaction assessment questionnaire and understanding of the preoperative medical information received for experimental groupe before and after the presentation of the EDOP plateform.
4 Items. Item 1 "quality of information" : 2 questions clear information and understanding in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally).
Item 2 necessity of complementary information, choice between no, a few, many information.
Item 3 "comprehension on different topics explained by the physician conserning the surgery. This item is devided in 6 questions in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally).
Item 4 Visual analog scale rate from 0 not satisfied at all, to 100 totally satisfied.
State-Trait Anxiety Inventory (STAI-TRAIT) SCORE
trait anxiety score. 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety.
Full Information
NCT ID
NCT04571736
First Posted
July 27, 2020
Last Updated
September 18, 2023
Sponsor
University Hospital, Montpellier
Collaborators
EDOP
1. Study Identification
Unique Protocol Identification Number
NCT04571736
Brief Title
Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform
Acronym
AMEDOP
Official Title
Interest of Improving Preoperative Medical Information by Video Support and Personalized and Secure Web Platform: Pilot Study in Thyroid Surgery (AMEDOP)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
EDOP
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient.
There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time.
The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.
Detailed Description
The objective is to assess the impact of additional, personalized and accessible preoperative medical information via a secure internet platform on the anxiety level of patients before their surgery. For this, patients agreeing to participate in the study will be randomized (drawn at random) during the inclusion visit and divided into one of the following two groups:
The control group: patients included in this group will receive the usual medical information as part of the surgery performed;
The experimental group: the patients included in this group will have, in addition to the usual medical information, personalized and secure access to a platform so that they can have additional information on the surgery performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid
Keywords
Preoperative Procedure, Instructional Films and Video
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
access to the internet information platform
Arm Type
Active Comparator
Arm Description
usual preoperative information and access to the internet information platform
Arm Title
usual preoperative information
Arm Type
No Intervention
Arm Description
medical information delivered to the patient before any surgery
Intervention Type
Other
Intervention Name(s)
access to the internet information platform
Intervention Description
This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time.
Primary Outcome Measure Information:
Title
Amsterdam Preoperative Anxiety and Information Scale (APAIS) SCORE
Description
rate of patients with perioperative anxiety symptoms refind by APAIS SCORE >= 11.
Rate from 1 (absent) to 5 (extrem). Score 2 to 4 : rejection of information, 5 to 7 : medium desire for information, > 7 : hungry for information.
Time Frame
Baseline Day [-90 / -7] and Surgery Day [-1 / 0]
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI-ETAT) SCORE
Description
overall anxiety score. 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety.
Time Frame
Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30]
Title
Internet use self-questionnaire
Description
Description of internet use and median number of internet use during the preoperative period collected using the follow-up book given to the patient during the inclusion visit.
4 items, if the answer for the 1st item is YES (Do you regulary consult the Internet for your health?) the subject must complete the item 2 and 4. If it's NO the subject must complete only the item 3.
Item 2 is "why are you consulting internet" the subject had 3 possibility multiple choice questionnaire by answering with yes or no.
Item 3 "Why the subject Don't use internet" 3 possibility multiple choice questionnaire by answering with yes or no.
Item 4 "utility of the information found on internet" rate from 1 (none) to 5 (very important).
Time Frame
Baseline Day [-90 / -7]
Title
Internet use self-questionnaire
Description
Description of internet use and median number of internet use during the preoperative period collected using the follow-up book given to the patient during post opérative visit.
4 items, if the answer for the 1st item is YES (Do you regulary consult the Internet for your health?) the subject must complete the item 2 and 4. If it's NO the subject must complete only the item 3.
Item 2 is "why are you consulting internet" the subject had 3 possibility multiple choice questionnaire by answering with yes or no.
Item 3 "Why the subject Don't use internet" 3 possibility multiple choice questionnaire by answering with yes or no.
Item 4 "utility of the information found on internet" rate from 1 (none) to 5 (very important).
Time Frame
Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30]
Title
specific questionnaire EDOP
Description
specific questionnaire in experimental group on the internet platform. 6 Items. Items 1, 2, 3, 6 in the form of a 5-response Likert scale (from 1: not satisfied at all, to 5 very satisfied).
Item 4 number of times the platform is consulted. Item 5 is if the subject had consulted other website after consulting EDOP platform. If yes how many times, and the name(s) of the website, why did you consult website.
Time Frame
post-operative visit Day [5-30] after viewing the screening video
Title
satisfaction assessment questionnaire and understanding of the preoperative medical information for control group
Description
Level of satisfaction and understanding obtained on the satisfaction assessment questionnaire and understanding of the preoperative medical information received for the control group.
4 Items. Item 1 "quality of information" : 2 questions clear information and understanding in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally).
Item 2 necessity of complementary information, choice between no, a few, many information.
Item 3 "comprehension on different topics explained by the physician conserning the surgery. This item is devided in 6 questions in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally).
Item 4 Visual analog scale rate from 0 not satisfied at all, to 100 totally satisfied.
Time Frame
Baseline Day [-90 / -7], Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]
Title
satisfaction assessment questionnaire and understanding of the preoperative medical information for experimental groupe
Description
Level of satisfaction and understanding obtained on the satisfaction assessment questionnaire and understanding of the preoperative medical information received for experimental groupe before and after the presentation of the EDOP plateform.
4 Items. Item 1 "quality of information" : 2 questions clear information and understanding in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally).
Item 2 necessity of complementary information, choice between no, a few, many information.
Item 3 "comprehension on different topics explained by the physician conserning the surgery. This item is devided in 6 questions in the form of a 5-response Likert scale (from 1: not at all, to 5 Totally).
Item 4 Visual analog scale rate from 0 not satisfied at all, to 100 totally satisfied.
Time Frame
2 times at Baseline Day [-90 / -7] before and after the presentation of EDOP platform, Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]
Title
State-Trait Anxiety Inventory (STAI-TRAIT) SCORE
Description
trait anxiety score. 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety.
Time Frame
Baseline Day[ -90 / -7]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 75,
Indication of lobo-isthmectomy or total thyroidectomy
Compliance for the completion of self-questionnaires
Person affiliated or beneficiary of a social security scheme.
Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
Difficulty understanding the French language
Lack of internet access
Persons placed under the protection of justice,
Person under guardianship or curatorship
Person participating in another research including an exclusion period still in progress,
Subject with severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant
Pregnant / lactating woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cesar Cartier, PI
Phone
0467336895
Ext
+33
Email
c-cartier@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Susana Leornard, CRA
Phone
04 67 33 61 56
Ext
+33
Email
s-leonard@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar Cartier, PI
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Gui de Chauliac
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana LEONARD, CRA
Phone
04 67 33 61 56
Ext
+33
Email
s-leonard@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Cesar Cartier, PI
First Name & Middle Initial & Last Name & Degree
Thibault Kennel, sub- PI
First Name & Middle Initial & Last Name & Degree
Agnes Viquesnel, sub-PI
12. IPD Sharing Statement
Learn more about this trial
Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform
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