Informed ConsentNCT05414435
Informed Consent in Endoscopy: Read, Understood or Merely Signed?
An observational study of Informed Consent and Gastrointestinal Endoscopy, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informed Consent, Gastrointestinal Endoscopy
- What is being tested?
- Reading of informed consent form
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 232 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients refered for elective endoscopic procedures
Who may be able to join
- Adult patients able to autonomously give informed consent
- Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.
Who cannot join
- Patients refered to urgent endoscopic procedures
- Patients refered for endoscopic procedures with deep sedation
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Reading of informed consent form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading of informed consent formBehavioural
Patients that adequately read informed consent forms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Apr 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Tondela-Viseu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Carvalho, Centro Hospitalar Tondela-Viseu
- Investigators
- Ricardo A Cardoso, MD, Study director, Centro Hospitalar Tondela-Viseu, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414435
- Sponsor's protocol ID
- CHTV07/2022.1
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carvalho AC, Cardoso R, Vieira HM, Silva A. Informed consent in endoscopy: Read, understood, or just signed? IGIE. 2024 Apr 9;3(2):222-229. doi: 10.1016/j.igie.2024.04.001. eCollection 2024 Jun.
PubMed 41647094
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Consent in Endoscopy: Read, Understood or Merely Signed?
- ClinicalTrials.gov ID
- NCT05414435
- Acronym / sponsor ID
- CHTV07/2022.1
- Conditions
- Informed Consent, Gastrointestinal Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Centro Hospitalar Tondela-ViseuUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients refered for elective endoscopic procedures
Key inclusion criteria (2 listed)
- Adult patients able to autonomously give informed consent
- Patients refered to elective endoscopic procedures (upper digestive endoscopy and/or colonoscopy) without deep sedation.
Key exclusion criteria (2 listed)
- Patients refered to urgent endoscopic procedures
- Patients refered for endoscopic procedures with deep sedation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reading of informed consent formPatients that adequately read informed consent forms | Behavioural | – |
Primary outcome
Assessing the percentage of patients who adequate read informed consent forms
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 41647094Carvalho AC, Cardoso R, Vieira HM, Silva A. Informed consent in endoscopy: Read, understood, or just signed? IGIE. 2024 Apr 9;3(2):222-229. doi: 10.1016/j.igie.2024.04.001. eCollection 2024 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A Cardoso, MD study director
Centro Hospitalar Tondela-Viseu, E.P.E.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Informed Consent and Gastrointestinal Endoscopy, run by Centro Hospitalar Tondela-Viseu at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the percentage of patients who adequate read informed consent forms (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05414435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.