NCT04856943

Effectiveness of Smartconsent in Improving Understanding of Informed Consent

Evaluation of the Effectiveness of Smartconsent to Improve Understanding of Informed Consent in Prostate Laser Enucleation Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Bioaraba Health Research Institute · Network
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice. A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC ENUCLEATION.

Detailed description

Male patients aged between 50 and 70 years, belonging to the Hospital Universitario Araba who are going to undergo PROSTATIC LASER ENUCLEATION, and who attend urology consultation between December 2019 and December 2020, and who meet the inclusion criteria and none of the exclusion criteria. Inclusion criteria: * Patients willing to receive information via tablet. * Patients who know how to and can read. Exclusion criteria: -Not applicable. Main variable: score on the Multiple choice test questionnaire (designed specifically for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information that an informed consent should provide (1, 2), with 4 response options and only one correct answer. An average score will be calculated for each patient. This test evaluates the comprehension of the information provided through the informed consent.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	Smartconsent application	Patients asigned to smartconsent group will sign informed consent through a Tablet.
OTHER	Control group	Patient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice

Timeline

• Start date: 2021-12-31
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-04-23
• Last updated: 2022-07-18

Locations

2 sites across 1 country: Spain