Bariatric Surgery CandidateNCT03653962
Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content
A study testing video assisted group and non-video group in people with Bariatric Surgery Candidate, run by Inonu University.
Trial summary
This study evaluates the addition of video presentation on conventional informed consent. Participants divided two randomly, one group read only conventional informed consent, the other video presentation was watched after reading conventional consent. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- video assisted group and non-video group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Mar 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being a being bariatric metabolic surgery candidate according to international guidelines
Who cannot join
- illiterate
- previous bariatric surgery
- age <18
About this study
Official title: Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content: Randomized Controlled Trial
This study evaluates the addition of video presentation on conventional informed consent. Participants divided two randomly, one group read only conventional informed consent, the other video presentation was watched after reading conventional consent.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- video assisted group, non-video group
- Keywords
- Multimedia, informed consent, metabolic surgery, Roux-en-Y gastric bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video assisted groupBehavioural
non-video groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| only informed consent | Active comparator | The first group was given verbal-written informed consent and a 15 question quiz about the informed consent content afterwards. Receives: Behavioral: non-video group |
| video assisted group | Experimental | The second group got an additional information video presentation and then the same quiz. Receives: Behavioral: video assisted group; Behavioral: non-video group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
In the video group : verbal-written consent + video presentation In the conventional consent group: only verbal-written consent
The video consisted of a summary of the written informed consent. Questionnaire consist of 15 questions quiz was given to both groups. Each question was rated on 15 points. 1point = bad score means don't understand informed consent. 15 point = full score means good understanding.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study startOct 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kutay Saglam, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653962
- Sponsor's protocol ID
- Kutay Saglam
- Status last verified
- Aug 2018
- First submitted
- 28 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Assisted Presentation Before Bariatric Surgery Enhanced Understanding of Informed Consent Content: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03653962
- Acronym / sponsor ID
- Kutay Saglam
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Multimedia, informed consent, metabolic surgery, Roux-en-Y gastric bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 31 Aug 2018 (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.
This study evaluates the addition of video presentation on conventional informed consent. Participants divided two randomly, one group read only conventional informed consent, the other video presentation was watched after reading conventional consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| only informed consent | Active comparator | Behavioral: non-video groupThe first group was given verbal-written informed consent and a 15 question quiz about the informed consent content afterwards. |
| video assisted group | Experimental | Behavioral: video assisted group, Behavioral: non-video groupThe second group got an additional information video presentation and then the same quiz. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- being a being bariatric metabolic surgery candidate according to international guidelines
Key exclusion criteria (3 listed)
- illiterate
- previous bariatric surgery
- age <18
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 |
|---|---|---|
| video assisted group | Behavioural | video assisted group |
| non-video group | Behavioural | only informed consent, video assisted group |
Primary outcome
Questionnaire
Time frame: six months
In the video group : verbal-written consent + video presentation In the conventional consent group: only verbal-written consent The video consisted of a summary of the written informed consent. Questionnaire consist of 15 questions quiz was given to both groups. Each question was rated on 15 points. 1point = bad score means don't understand informed consent. 15 point = full score means good understanding.
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 31 Aug 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing video assisted group and non-video group in people with Bariatric Surgery Candidate, run by Inonu University.
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 1 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Questionnaire (time frame: six months). 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 31 Aug 2018.