Effectiveness of Smartconsent in Improving Understanding of Informed Consent (SMARTCONSENT)

July 14, 2022 updated by: Bioaraba Health Research Institute

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

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

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alava
      • Vitoria Gasteiz, Alava, Spain, 01003
        • Imanol Merino
      • Vitoria-gasteiz, Alava, Spain, 01009
        • Bioaraba Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients willing to receive information via tablet.
  • Patients who know and can read.

Exclusion Criteria:

  • Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: IMANOL MERINO, Bioaraba Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 31, 2021

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (ACTUAL)

April 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • SMARTCONSENT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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