Effectiveness of Smartconsent in Improving Understanding of Informed Consent

Benign Prostatic Hyperplasia Clinical Trial

— SMARTCONSENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856943
• Other study ID #: SMARTCONSENT
• Status: Completed
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Bioaraba Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

Inclusion criteria:

• Patients willing to receive information via tablet.

• Patients who know and can read.

Exclusion Criteria:

• Not applicable

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Spain	Imanol Merino	Vitoria Gasteiz	Alava
Spain	Bioaraba Health Research Institute	Vitoria-gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Bioaraba Health Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score in the Multiple choice test questionnaire	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	At the recruitment moment
Secondary	Satisfaction with the informed consent proccess	based on three ad hoc designed items: Each item will be scored on a lipo Likert scale with 5 response options.	At the recruitment moment
Secondary	Ability to complete the informed consent form	Without the need for additional information from the healthcare professional.	At the recruitment moment
Secondary	Time required to complete the informed consent process (MIN).	The Smartphone stopwatch of the researchers participating in the study will be used for this purpose	At the recruitment moment
Secondary	Overall satisfaction with the informed consent process,	Through a three-item test, developed ad hoc by a group of researchers to assess satisfaction in a study with similar characteristics to ours.	At the recruitment moment
Secondary	Score in the System Usability Scale	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.	At the recruitment moment