NCT03653962

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

August 28, 2018

Last Update Submit

August 29, 2018

Conditions

Bariatric Surgery Candidate

Keywords

Multimediainformed consentmetabolic surgeryRoux-en-Y gastric bypass

Outcome Measures

Primary Outcomes (1)

  • 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.

    six months

Study Arms (2)

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.

Behavioral: non-video group

video assisted group

EXPERIMENTAL

The second group got an additional information video presentation and then the same quiz.

Behavioral: video assisted groupBehavioral: non-video group

Interventions

video assisted groupBEHAVIORAL
video assisted group
non-video groupBEHAVIORAL
only informed consentvideo assisted group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being a being bariatric metabolic surgery candidate according to international guidelines

You may not qualify if:

  • illiterate
  • previous bariatric surgery
  • age \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Gastrointestinal Surgery Fellow

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 31, 2018

Study Start

October 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share