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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04856943
Other study ID # SMARTCONSENT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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