Benign Prostatic HyperplasiaSMARTCONSENTNCT04856943
Effectiveness of Smartconsent in Improving Understanding of Informed Consent
A study testing Smartconsent application in people with Benign Prostatic Hyperplasia, run by Bioaraba Health Research Institute at 2 sites in Spain.
Trial summary
The general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice. A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC ENUCLEATION. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Smartconsent application
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesSpain
- Study dates
- 31 Dec 2021to 31 Dec 2021
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients willing to receive information via tablet.
- Patients who know and can read.
Who cannot join
- Not applicable
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Imanol Merino
Vitoria-Gasteiz, Alava, 01003
Bioaraba Health Research Institute
Vitoria-Gasteiz, Alava, 01009
About this study
Official title: Evaluation of the Effectiveness of Smartconsent to Improve Understanding of Informed Consent in Prostate Laser Enucleation Procedures
The general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice.
A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC ENUCLEATION.
Read the detailed description
Male patients aged between 50 and 70 years, belonging to the Hospital Universitario Araba who are going to undergo PROSTATIC LASER ENUCLEATION, and who attend urology consultation between December 2019 and December 2020, and who meet the inclusion criteria and none of the exclusion criteria.
Inclusion criteria:
- Patients willing to receive information via tablet.
- Patients who know how to and can read.
Exclusion criteria:
-Not applicable.
Main variable: score on the Multiple choice test questionnaire (designed specifically for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information that an informed consent should provide (1, 2), with 4 response options and only one correct answer. An average score will be calculated for each patient.
This test evaluates the comprehension of the information provided through the informed consent.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Smartconsent application, Control group
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartconsent applicationProcedure or surgery
Patients asigned to smartconsent group will sign informed consent through a Tablet.
Control groupOther
Patient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice
| Study group | Role | What they receive |
|---|---|---|
| smartconsent group | Experimental | Intervention group: : the principal investigator upon receiving the tablet enters with his/her user and password, registers his/her signature, selects the patient (anonymized), selects the intervention and then the tablet will be given to the patient and he/she will be instructed to follow the indications in order to be able to project the video and digitally sign the informed consent. Receives: Procedure: Smartconsent application |
| control group | Placebo comparator | Control group: The informed consent paper document (official format) will be printed with the patient's name, signed by the physician (principal investigator) and given to the patient to read and sign. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score in the Multiple choice test questionnaire
Specifically designed for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information to be provided in an informed consent form, with 4 response options and only one correct answer
Measured: At the recruitment moment
Secondary outcomes (5)
Satisfaction with the informed consent proccess
based on three ad hoc designed items: Each item will be scored on a lipo Likert scale with 5 response options.
Measured: At the recruitment moment
Ability to complete the informed consent form
Without the need for additional information from the healthcare professional.
Measured: At the recruitment moment
Time required to complete the informed consent process (MIN).
The Smartphone stopwatch of the researchers participating in the study will be used for this purpose
Measured: At the recruitment moment
Overall satisfaction with the informed consent process,
Through a three-item test, developed ad hoc by a group of researchers to assess satisfaction in a study with similar characteristics to ours.
Measured: At the recruitment moment
Score in the System Usability Scale
In the SMARTCONSENT group only. he average System Usability Scale score is 68. If your score is under 68, then there are probably serious problems with your website usability which you should address. If your score is above 68, then you can relax a little bit.
Measured: At the recruitment moment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start31 Dec 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioaraba Health Research Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- IMANOL MERINO, Principal investigator, Bioaraba Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856943
- Sponsor's protocol ID
- SMARTCONSENT
- Acronym
- SMARTCONSENT
- Status last verified
- Jul 2022
- First submitted
- 20 Apr 2021
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Smartconsent to Improve Understanding of Informed Consent in Prostate Laser Enucleation Procedures
- ClinicalTrials.gov ID
- NCT04856943
- Acronym / sponsor ID
- SMARTCONSENT / SMARTCONSENT
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Bioaraba Health Research InstituteResearch network
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Apr 2021 (actual)
- 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 general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice.
A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC ENUCLEATION.
Detailed description
Male patients aged between 50 and 70 years, belonging to the Hospital Universitario Araba who are going to undergo PROSTATIC LASER ENUCLEATION, and who attend urology consultation between December 2019 and December 2020, and who meet the inclusion criteria and none of the exclusion criteria.
Inclusion criteria:
- Patients willing to receive information via tablet.
- Patients who know how to and can read.
Exclusion criteria:
-Not applicable.
Main variable: score on the Multiple choice test questionnaire (designed specifically for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information that an informed consent should provide (1, 2), with 4 response options and only one correct answer. An average score will be calculated for each patient.
This test evaluates the comprehension of the information provided through the informed consent.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smartconsent group | Experimental | Procedure: Smartconsent applicationIntervention group: : the principal investigator upon receiving the tablet enters with his/her user and password, registers his/her signature, selects the patient (anonymized), selects the intervention and then the tablet will be given to the patient and he/she will be instructed to follow the indications in order to be able to project the video and digitally sign the informed consent. |
| control group | Placebo comparator | Other: Control groupControl group: The informed consent paper document (official format) will be printed with the patient's name, signed by the physician (principal investigator) and given to the patient to read and sign. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients willing to receive information via tablet.
- Patients who know and can read.
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Smartconsent applicationPatients asigned to smartconsent group will sign informed consent through a Tablet. | Procedure or surgery | smartconsent group |
| Control groupPatient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice | Other | control group |
Primary outcome
Score in the Multiple choice test questionnaire
Time frame: At the recruitment moment
Specifically designed for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information to be provided in an informed consent form, with 4 response options and only one correct answer
5 secondary outcomes
Satisfaction with the informed consent proccess
Time frame: At the recruitment moment
Ability to complete the informed consent form
Time frame: At the recruitment moment
Time required to complete the informed consent process (MIN).
Time frame: At the recruitment moment
Overall satisfaction with the informed consent process,
Time frame: At the recruitment moment
Score in the System Usability Scale
Time frame: At the recruitment moment
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 18 Jul 2022.
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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.
IMANOL MERINO principal investigator
Bioaraba Health Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartconsent application in people with Benign Prostatic Hyperplasia, run by Bioaraba Health Research Institute at 2 sites 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 1 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Score in the Multiple choice test questionnaire (time frame: At the recruitment moment). 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 18 Jul 2022.