NCT03960723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

May 21, 2019

Last Update Submit

September 21, 2023

Conditions

Informed Consent

Keywords

Informed consent

Outcome Measures

Primary Outcomes (1)

  • Understanding degree

    Assessment of the understanding degree of the IC by the patient

    Before procedure

Interventions

QuestionnaireOTHER

A questionnaire asking the patients for several questions related to the Informed Consent Form they have signed before surgery, will be administered.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rosa Mª Antonijoan Arbos, MD, PhD

    Institut de Recerca de l´Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

May 9, 2019

Primary Completion

December 9, 2019

Study Completion

December 9, 2019

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations

ES(1)