Descriptive Study to Evaluate the Understanding Degree of... | NCT03960723

Studies
Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures

NCT03960723

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status

Completed

Last Update Posted

Sep 25, 2023Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Informed Consent

Interventions

Questionnaire

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2019Actual

Primary Completion Date

Dec 9, 2019Actual

Completion Date

Dec 9, 2019Actual

First Submitted Date

May 21, 2019

First Submission Date that Met QC Criteria

May 21, 2019

First Posted Date

May 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2023

Last Update Posted Date

Sep 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	A questionnaire asking the patients for several questions related to the Informed Consent Form they have signed before surgery, will be administered.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Understanding degree	Assessment of the understanding degree of the IC by the patient	Before procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing surgery and admitted by CSI unit
Provide written informed consent to participate in the study

Exclusion Criteria:

Patients who need a legal representative to read, understand and sign the CI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients ≥ 18 years, who undergoing surgery and are admitted by CSI unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rosa Mª Antonijoan Arbos, MD, PhD	Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de la Santa Creu i Sant Pau		Barcelona		08041	Spain

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided