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Completed

NCT Number: NCT04856943

Effectiveness of Smartconsent in Improving Understanding of Informed Consent

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bioaraba Health Research Institute, Vitoria-Gasteiz, Alava, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not applicable

Treatment and study plan

Smartconsent application

Procedure

Patients asigned to smartconsent group will sign informed consent through a Tablet.

Control Group

Other

Patient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. Ability to complete the informed consent form

    Time frame: At the recruitment moment

    Without the need for additional information from the healthcare professional.

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Bioaraba Health Research Institute

Network

Registry information

Official study title

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

Acronym: SMARTCONSENT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2021
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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