Effectiveness of Smartconsent in Improving Understanding of Informed Consent (SMARTCONSENT)

Bioaraba Health Research Institute

Status: Completed

Conditions: Benign Prostatic Hyperplasia

Treatments: Other: Control group; Procedure: Smartconsent application

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04856943

SMARTCONSENT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients willing to receive information via tablet.
• Patients who know and can read.

Exclusion criteria

• Not applicable

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups, including a placebo group

smartconsent group

Experimental group

Description:

Intervention group: : the principal investigator upon receiving the tablet enters with his/her user and password, registers his/her signature, selects the patient (anonymized), selects the intervention and then the tablet will be given to the patient and he/she will be instructed to follow the indications in order to be able to project the video and digitally sign the informed consent.

Treatment:

Procedure: Smartconsent application

control group

Placebo Comparator group

Description:

Control group: The informed consent paper document (official format) will be printed with the patient's name, signed by the physician (principal investigator) and given to the patient to read and sign.

Treatment:

Other: Control group