Informed Consent in Endoscopy: Read, Understood or Merely Signed?

NCT05414435 | Completed

• 1 other identifier: CHTV07/2022.1
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

Informed consent form is a legal document that, ethically, should be obtained before any endoscopic procedure is performed. The main purpose of this research study is to assess the readability, comprehensibility and applicability of the new informed consent proposed by the Portuguese Society of Digestive Endoscopy as a way to standardize the information provided to patients prior to endoscopic exams.

Conditions

Informed Consent; Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (1)

• Assessing the percentage of patients who adequate read informed consent forms

  Assess if patients "adequately read" informed consent forms - "adequate reading" was defined by checking all of the following: signing of informed consent form; fulfilment of a questionnaire regarding medical history and drugs; underlining a small sentence added to the orignial version of informed consent form. Patients not meeting all the defined criteria were considered not to have adequately read the informed consent.

  12 months

Interventions

Reading of informed consent form BEHAVIORAL

Patients that adequately read informed consent forms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients refered for elective endoscopic procedures

You may qualify if:

• Adult patients able to autonomously give informed consent
• Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.

You may not qualify if:

• Patients refered to urgent endoscopic procedures
• Patients refered for endoscopic procedures with deep sedation

Sponsors & Collaborators

• Centro Hospitalar Tondela-Viseu: lead

Study Sites (1)

Centro Hospitalar Tondela Viseu

Viseu, 3504-509, Portugal

Location

Study Officials

• Ricardo A Cardoso, MD

  Centro Hospitalar Tondela-Viseu, E.P.E.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 10, 2022
• Study Start: April 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)