- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04856943
Effectiveness of Smartconsent in Improving Understanding of Informed Consent (SMARTCONSENT)
Evaluation of the Effectiveness of Smartconsent to Improve Understanding of Informed Consent in Prostate Laser Enucleation Procedures
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alava
-
Vitoria Gasteiz, Alava, Spain, 01003
- Imanol Merino
-
Vitoria-gasteiz, Alava, Spain, 01009
- Bioaraba Health Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Patients willing to receive information via tablet.
- Patients who know and can read.
Exclusion Criteria:
- Not applicable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: smartconsent group
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.
|
Patients asigned to smartconsent group will sign informed consent through a Tablet.
|
PLACEBO_COMPARATOR: 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.
|
Patient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score in the Multiple choice test questionnaire
Time Frame: 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
|
At the recruitment moment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with the informed consent proccess
Time Frame: 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.
|
At the recruitment moment
|
Ability to complete the informed consent form
Time Frame: At the recruitment moment
|
Without the need for additional information from the healthcare professional.
|
At the recruitment moment
|
Time required to complete the informed consent process (MIN).
Time Frame: At the recruitment moment
|
The Smartphone stopwatch of the researchers participating in the study will be used for this purpose
|
At the recruitment moment
|
Overall satisfaction with the informed consent process,
Time Frame: 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.
|
At the recruitment moment
|
Score in the System Usability Scale
Time Frame: 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.
|
At the recruitment moment
|
Collaborators and Investigators
Investigators
- Principal Investigator: IMANOL MERINO, Bioaraba Health Research Institute
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMARTCONSENT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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