Effectiveness of Smartconsent in Improving Understanding of Informed Consent

NCT04856943 | Completed

• 1 other identifier: SMARTCONSENT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Satisfaction with the informed consent proccess

  At the recruitment moment

• Ability to complete the informed consent form

  At the recruitment moment

• Time required to complete the informed consent process (MIN).

  At the recruitment moment

• Overall satisfaction with the informed consent process,

  At the recruitment moment

• Score in the System Usability Scale

  At the recruitment moment

Study Arms (2)

smartconsent group

EXPERIMENTAL

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.

Procedure: Smartconsent application

control group

PLACEBO COMPARATOR

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.

Other: Control group

Interventions

Smartconsent application PROCEDURE

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

smartconsent group

Control group OTHER

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

control group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Bioaraba Health Research Institute: lead

Study Sites (2)

Imanol Merino

Vitoria-Gasteiz, Alava, 01003, Spain

Location

Bioaraba Health Research Institute

Vitoria-Gasteiz, Alava, 01009, Spain

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• IMANOL MERINO

  Bioaraba Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: December 31, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

ES (2)