Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Information Improvement for Surgical Patients Through Portable Video Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02846467
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : August 10, 2016
Sponsor:
Collaborator:
University of Cadiz
Information provided by (Responsible Party):
Sebastian Armijos, Hospital Universitario Puerto Real

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).

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Bladder Cancer Other: Informed consent trough a portable video media Other: Written informed consent Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.
Study Start Date : December 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Portable video media
Patients who receive informed consent trough portable video media around 10 minutes
Other: Informed consent trough a portable video media
Information provided to patients using the mobile application (iURO app)
Other Name: iURO Application (App)

Active Comparator: Traditional IC
Patients who receive traditional IC (written consent) during 10 to 15 minutes
Other: Written informed consent
Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.
Other Names:
  • Traditional informed consent
  • Standard verbal communication




Primary Outcome Measures :
  1. Comprehension of informed consent [ Time Frame: Prior to surgery ]

Secondary Outcome Measures :
  1. Comprehension of informed consent [ Time Frame: 15 days after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846467


Locations
Layout table for location information
Spain
Urology Department of the University Hospital of Puerto Real
Puerto Real, Cadiz, Spain, 11510
Sponsors and Collaborators
Hospital Universitario Puerto Real
University of Cadiz
Investigators
Layout table for investigator information
Principal Investigator: Sebastian Armijos Leon, Urologist Hospital Universitario Puerto Real
Study Director: Federico Rodriguez Rubio, Urologist Univesity of Cadiz
Study Chair: Jorge Rioja Zuazu, Urologist Universidad de Zaragoza

Additional Information:
Layout table for additonal information
Responsible Party: Sebastian Armijos, PhD Urologist, Hospital Universitario Puerto Real
ClinicalTrials.gov Identifier: NCT02846467     History of Changes
Other Study ID Numbers: HospitalUPR
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Sebastian Armijos, Hospital Universitario Puerto Real:
Informed consent
Patient Education
Mobile applications

Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Hyperplasia
Prostatic Hyperplasia
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male