NCT02846467

Brief Summary

The aim of this study is to evaluate the comprehension of the Informed consent with the Standard Verbal Communication (SVC) versus Portable Video Media (PVM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

July 22, 2016

Last Update Submit

August 8, 2016

Conditions

Prostatic HyperplasiaBladder Cancer

Keywords

Informed consentPatient EducationMobile applications

Outcome Measures

Primary Outcomes (1)

  • Comprehension of informed consent

    Prior to surgery

Secondary Outcomes (1)

  • Comprehension of informed consent

    15 days after surgery

Study Arms (2)

Portable video media

EXPERIMENTAL

Patients who receive informed consent trough portable video media around 10 minutes

Other: Informed consent trough a portable video media

Traditional IC

ACTIVE COMPARATOR

Patients who receive traditional IC (written consent) during 10 to 15 minutes

Other: Written informed consent

Interventions

Informed consent trough a portable video mediaOTHER

Information provided to patients using the mobile application (iURO app)

Also known as: iURO Application (App)
Portable video media
Written informed consentOTHER

Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.

Also known as: Traditional informed consent, Standard verbal communication
Traditional IC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are going to receive transurethral resection of bladder or prostate
  • Patients, women and men, older than 18 years without any mental disability

You may not qualify if:

  • Patients who refuse to participate in the study
  • Patients who have inability to communicate in spanish.
  • Several visual problems that limit the ability to read written material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Department of the University Hospital of Puerto Real

Puerto Real, Cadiz, 11510, Spain

Location

Related Links

MeSH Terms

Conditions

Prostatic HyperplasiaUrinary Bladder Neoplasms

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder DiseasesUrologic Diseases

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Sebastian Armijos Leon, Urologist

    Hospital Universitario Puerto Real

    PRINCIPAL INVESTIGATOR

  • Federico Rodriguez Rubio, Urologist

    Univesity of Cadiz

    STUDY DIRECTOR

  • Jorge Rioja Zuazu, Urologist

    Universidad de Zaragoza

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Urologist

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 27, 2016

Study Start

December 1, 2013

Primary Completion

October 1, 2015

Study Completion

April 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

The database with the demographic and results of the participant is going to be available during the next six months. The information will be send with an email request.

Locations

ES(1)