Information Improvement for Surgical Patients Through Portable Video Media

Bladder Cancer Clinical Trial

Official title:

Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846467
• Other study ID #: HospitalUPR
• Status: Completed
• Phase: N/A
• First received: July 22, 2016
• Last updated: August 8, 2016
• Start date: December 2013
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Hospital Universitario Puerto Real
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bladder Cancer
• Hyperplasia
• Prostatic Hyperplasia
• Urinary Bladder Neoplasms

Intervention

Other:
• Informed consent trough a portable video media
Information provided to patients using the mobile application (iURO app)
• Written informed consent
Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.

Locations

Country	Name	City	State
Spain	Urology Department of the University Hospital of Puerto Real	Puerto Real	Cadiz

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Puerto Real	University of Cadiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehension of informed consent		Prior to surgery	Yes
Secondary	Comprehension of informed consent		15 days after surgery	Yes

External Links

•   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