Prostatic HyperplasiaNCT02846467
Information Improvement for Surgical Patients Through Portable Video Media
A study testing Informed consent trough a portable video media and Written informed consent in people with Prostatic Hyperplasia and Bladder Cancer, run by Hospital Universitario Puerto Real at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostatic Hyperplasia, Bladder Cancer
- What is being tested?
- Informed consent trough a portable video media and Written informed consent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are going to receive transurethral resection of bladder or prostate
- Patients, women and men, older than 18 years without any mental disability
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Urology Department of the University Hospital of Puerto Real
Puerto Real, Cadiz, 11510
About this study
Official title: Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.
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).
Read the 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.
- Conditions
- Prostatic Hyperplasia, Bladder Cancer
- Being tested
- Informed consent trough a portable video media, Written informed consent
- Keywords
- Informed consent, Patient Education, Mobile applications
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed consent trough a portable video mediaOther
Also called iURO Application (App)
Information provided to patients using the mobile application (iURO app)
Written informed consentOther
Also called Traditional informed consent, Standard verbal communication
Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.
| Study group | Role | What they receive |
|---|---|---|
| Portable video media | Experimental | Patients who receive informed consent trough portable video media around 10 minutes Receives: Other: Informed consent trough a portable video media |
| Traditional IC | Active comparator | Patients who receive traditional IC (written consent) during 10 to 15 minutes Receives: Other: Written informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of informed consent
Measured: Prior to surgery
Secondary outcomes (1)
Comprehension of informed consent
Measured: 15 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startDec 2013
- Primary completionOct 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Puerto Real
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cadiz
- Responsible party
- Principal investigator, Sebastian Armijos, Hospital Universitario Puerto Real
- Investigators
- Sebastian Armijos Leon, Urologist, Principal investigator, Hospital Universitario Puerto RealFederico Rodriguez Rubio, Urologist, Study director, Univesity of CadizJorge Rioja Zuazu, Urologist, Study chair, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846467
- Sponsor's protocol ID
- HospitalUPR
- Status last verified
- Aug 2016
- First submitted
- 22 Jul 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Understanding of Informed Consent Between Portable Video Media Versus Written Consent at Urological Surgeries.
- ClinicalTrials.gov ID
- NCT02846467
- Acronym / sponsor ID
- HospitalUPR
- Conditions
- Prostatic Hyperplasia, Bladder Cancer
- Keywords
- Informed consent, Patient Education, Mobile applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Hospital Universitario Puerto RealUniversity, hospital or other
- Collaborators
- University of Cadiz
- Study start
- Dec 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portable video media | Experimental | Other: Informed consent trough a portable video mediaPatients who receive informed consent trough portable video media around 10 minutes |
| Traditional IC | Active comparator | Other: Written informed consentPatients who receive traditional IC (written consent) during 10 to 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are going to receive transurethral resection of bladder or prostate
- Patients, women and men, older than 18 years without any mental disability
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informed consent trough a portable video mediaAlso: iURO Application (App)Information provided to patients using the mobile application (iURO app) | Other | Portable video media |
| Written informed consentAlso: Traditional informed consent, Standard verbal communicationInformation provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate. | Other | Traditional IC |
Primary outcome
Comprehension of informed consent
Time frame: Prior to surgery
1 secondary outcome
Comprehension of informed consent
Time frame: 15 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
- 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, GreeceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Armijos Leon, Urologist principal investigator
Hospital Universitario Puerto Real
Federico Rodriguez Rubio, Urologist study director
Univesity of Cadiz
Jorge Rioja Zuazu, Urologist study chair
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informed consent trough a portable video media and Written informed consent in people with Prostatic Hyperplasia and Bladder Cancer, run by Hospital Universitario Puerto Real at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension of informed consent (time frame: Prior to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.