Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform

Thyroid Clinical Trial

— AMEDOP  

Official title:

Interest of Improving Preoperative Medical Information by Video Support and Personalized and Secure Web Platform: Pilot Study in Thyroid Surgery (AMEDOP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04571736
• Other study ID #: RECHMPL19_0085 (7782)
• Secondary ID: 2019-A02241-56
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Montpellier
• Contact: Cesar Cartier, PI
• Phone: 0467336895
• Email: c-cartier[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid
• Thyroid Diseases

Intervention

Other:
• access to the internet information platform
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.

Locations

Country	Name	City	State
France	CHU Gui de Chauliac	Montpellier	Hérault

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	EDOP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline Day [-90 / -7] and Surgery Day [-1 / 0]
Secondary	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.	Baseline Day[ -90 / -7], Surgery Day [-1 / 0], discharge from the hospital Day [0 / 7] and postoperative visit Day [5-30]
Secondary	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).	Baseline Day [-90 / -7]
Secondary	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).	Surgery Day [ -1 / 0], Discharge from hospital Day [0-7] and postoperative visit Day [5-30]
Secondary	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.	post-operative visit Day [5-30] after viewing the screening video
Secondary	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.	Baseline Day [-90 / -7], Surgery Day [-1/0], at discharge from hospital Day [0-7] and at the postoperative visit Day [5-30]
Secondary	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.	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]
Secondary	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.	Baseline Day[ -90 / -7]