Benign Prostatic Hyperplasia
Conditions
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.
Interventions
PROCEDURESmartconsent application
Patients asigned to smartconsent group will sign informed consent through a Tablet.
OTHERControl group
Patient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice
Sponsors
Bioaraba Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients willing to receive information via tablet. * Patients who know and can read.
Exclusion criteria
* Not applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Ability to complete the informed consent form | At the recruitment moment | Without the need for additional information from the healthcare professional. |
| 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 |
| 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. |
| 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. |
Countries
Spain
Outcome results
None listed