Informed ConsentNCT03960723
Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures
An observational study of Informed Consent, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Informed Consent
- What is being tested?
- Questionnaire
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 9 May 2019to 9 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥ 18 years, who undergoing surgery and are admitted by CSI unit.
Who may be able to join
- Undergoing surgery and admitted by CSI unit
- Provide written informed consent to participate in the study
Who cannot join
- Patients who need a legal representative to read, understand and sign the CI
Trial locations and contacts
1 site in 1 country.
About this study
The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess.
The main goal of this study is to assess if patients that are going to be operated at Hospital de la Santa Creu i Sant Pau in the CSI (Surgery without previous hospitalization) unit, really understood the information about the procedure.
- Conditions
- Informed Consent
- Being tested
- Questionnaire
- Keywords
- Informed consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
A questionnaire asking the patients for several questions related to the Informed Consent Form they have signed before surgery, will be administered.
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding degree
Assessment of the understanding degree of the IC by the patient
Measured: Before procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start9 May 2019
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa Mª Antonijoan Arbos, MD, PhD, Principal investigator, Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960723
- Sponsor's protocol ID
- IIBSP-CIP-2019-25
- Status last verified
- Sep 2023
- First submitted
- 21 May 2019
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures
- ClinicalTrials.gov ID
- NCT03960723
- Acronym / sponsor ID
- IIBSP-CIP-2019-25
- Conditions
- Informed Consent
- Keywords
- Informed consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 23 May 2019 (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.
The Informed Consent (IC) of a medical procedure is the aceptation of a diagnostic or therapeutic procedure by the patient, after receiving the necessary and accurate information about it. Freedom, information and understanding have to be the main requirements in this proccess.
The main goal of this study is to assess if patients that are going to be operated at Hospital de la Santa Creu i Sant Pau in the CSI (Surgery without previous hospitalization) unit, really understood the information about the procedure.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years, who undergoing surgery and are admitted by CSI unit.
Key inclusion criteria (2 listed)
- Undergoing surgery and admitted by CSI unit
- Provide written informed consent to participate in the study
Key exclusion criteria (1 listed)
- Patients who need a legal representative to read, understand and sign the CI
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 |
|---|---|---|
| QuestionnaireA questionnaire asking the patients for several questions related to the Informed Consent Form they have signed before surgery, will be administered. | Other | – |
Primary outcome
Understanding degree
Time frame: Before procedure
Assessment of the understanding degree of the IC by the patient
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 25 Sep 2023.
Related trials for Informed Consent
Not yet recruitingObservational study
Implementing Dynamic Consent for Rare Disease Patients
Rare Disorders
Recruiting
Chatbot Implementation In The Clinical Informed Consent Process
Informed Consent
Recruiting
Improving Surgical Communication for Patients in Wisconsin
Surgeons, Surgical Procedure, Unspecified
Recruiting
Effect of Video -Based vs Standard ınformation on Maternal Anxiety and Procedure Decision in Pregnant Woman Offered Amniocentesis or Cvs
Maternal Anxiety, Prenatal Diagnosis
Not yet recruitingObservational study
Risk Sharing vs Risk Dumping: Parental Attitudes About Risks
Pediatric Surgery, Informed Consent
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.
Rosa Mª Antonijoan Arbos, MD, PhD principal investigator
Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau
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, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 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 25 Sep 2023. 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 Spain. 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?
Understanding degree (time frame: Before procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2023.