Effectiveness of Smartconsent in Improving Understanding of Informed Consent

Not Applicable

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Other: Control group; Procedure: Smartconsent application

• Registration Number: NCT04856943
• Lead Sponsor: Bioaraba Health Research Institute

Brief 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.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-23
• Study Start: 2021-12-31
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-14
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Control group	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.
smartconsent group	Smartconsent application	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.

Primary Outcome Measures

Name	Time	Method
Score in the Multiple choice test questionnaire	At the recruitment moment	Specifically designed for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information to be provided in an informed consent form, with 4 response options and only one correct answer

Secondary Outcome Measures

Name	Time	Method
Satisfaction with the informed consent proccess	At the recruitment moment	based on three ad hoc designed items: Each item will be scored on a lipo Likert scale with 5 response options.
Overall satisfaction with the informed consent process,	At the recruitment moment	Through a three-item test, developed ad hoc by a group of researchers to assess satisfaction in a study with similar characteristics to ours.
Time required to complete the informed consent process (MIN).	At the recruitment moment	The Smartphone stopwatch of the researchers participating in the study will be used for this purpose
Ability to complete the informed consent form	At the recruitment moment	Without the need for additional information from the healthcare professional.
Score in the System Usability Scale	At the recruitment moment	In the SMARTCONSENT group only. he average System Usability Scale score is 68. If your score is under 68, then there are probably serious problems with your website usability which you should address. If your score is above 68, then you can relax a little bit.

Trial Locations

Locations (2)

Bioaraba Health Research Institute; 🇪🇸 Vitoria-gasteiz, Alava, Spain

Imanol Merino; 🇪🇸 Vitoria Gasteiz, Alava, Spain