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Information Improvement for Surgical Patients Through Portable Video Media

Primary Purpose

Prostatic Hyperplasia, Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Informed consent trough a portable video media
Written informed consent
Sponsored by
Hospital Universitario Puerto Real
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostatic Hyperplasia focused on measuring Informed consent, Patient Education, Mobile applications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Urology Department of the University Hospital of Puerto Real

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Portable video media

Traditional IC

Arm Description

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

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

Outcomes

Primary Outcome Measures

Comprehension of informed consent

Secondary Outcome Measures

Comprehension of informed consent

Full Information

First Posted
July 22, 2016
Last Updated
August 8, 2016
Sponsor
Hospital Universitario Puerto Real
Collaborators
University of Cadiz
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1. Study Identification

Unique Protocol Identification Number
NCT02846467
Brief Title
Information Improvement for Surgical Patients Through Portable Video Media
Official Title
Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Puerto Real
Collaborators
University of Cadiz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
The informed consent (IC) is a fully ethical and legal consolidated requirement. IC is the voluntary authorization by a patient for surgical treatment (MeSH). The IC has to include: 1. What is and for what is it, 2. How is it made, 3. What effect will produce, 4. which patients will benefit, 5. Alternatives, 6. Risks and special situations. The standard IC is based in written and verbal information, but the information provided is insufficient, leading to misunderstanding and even litigation. Technology plays an important role in the improvement of IC: the portable video media, tablet, with the application (app) iURO assists the procedure through videos and illustrations. To evaluate and measure the comprehension of the information that patients received, we elaborated and validated a "Questionnaire to evaluate the comprehension of IC" (the process was mounted as "Questionnaire for urology IC validation" in the poster session at the 17th International European Association of Urology Nurses (EAUN) Meeting, Munich-Germany). The patients undergoing to bladder or prostate transurethral resection were selected. Afterwards they were randomized previous the interview, into two groups: patients informed by PVM with the app iUro (experimental group) versus patients with an SVC (control group). The questionnaire was used to compare the comprehension of the surgery immediately and 15 days after the surgery. The items regarding questionnaire were: information, utility of the intervention, side effects, complications, comorbidity, usefulness of information, anxiety and risks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Bladder Cancer
Keywords
Informed consent, Patient Education, Mobile applications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Portable video media
Arm Type
Experimental
Arm Description
Patients who receive informed consent trough portable video media around 10 minutes
Arm Title
Traditional IC
Arm Type
Active Comparator
Arm Description
Patients who receive traditional IC (written consent) during 10 to 15 minutes
Intervention Type
Other
Intervention Name(s)
Informed consent trough a portable video media
Other Intervention Name(s)
iURO Application (App)
Intervention Description
Information provided to patients using the mobile application (iURO app)
Intervention Type
Other
Intervention Name(s)
Written informed consent
Other Intervention Name(s)
Traditional informed consent, Standard verbal communication
Intervention Description
Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.
Primary Outcome Measure Information:
Title
Comprehension of informed consent
Time Frame
Prior to surgery
Secondary Outcome Measure Information:
Title
Comprehension of informed consent
Time Frame
15 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are going to receive transurethral resection of bladder or prostate Patients, women and men, older than 18 years without any mental disability Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Armijos Leon, Urologist
Organizational Affiliation
Hospital Universitario Puerto Real
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Federico Rodriguez Rubio, Urologist
Organizational Affiliation
Univesity of Cadiz
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jorge Rioja Zuazu, Urologist
Organizational Affiliation
Universidad de Zaragoza
Official's Role
Study Chair
Facility Information:
Facility Name
Urology Department of the University Hospital of Puerto Real
City
Puerto Real
State/Province
Cadiz
ZIP/Postal Code
11510
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Links:
URL
https://twitter.com/Uroweb/status/752027133837471744/photo/1
Description
Abstract entitled: "MHealth (Mobile Health):The use of portable video media versus standard verbal communication in the informed consent", presented at 5th Meeting of Uro-Technology (ESUT) held in Athens, Greece

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Information Improvement for Surgical Patients Through Portable Video Media

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