NCT01476319

Brief Summary

This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing patients in the emergency department (ED) about risks, benefits, and alternatives to receiving percutaneous cholecystostomy. Eligible patients will be approached when patients will be scheduled and waiting for receiving percutaneous cholecystostomy in the emergency department.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2014

Completed
Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

August 1, 2011

Last Update Submit

April 5, 2017

Conditions

Cholecystitis

Outcome Measures

Primary Outcomes (1)

  • knowledge and satisfaction measure

    One questionnaire will be used as an outcome measure tool. Participants will be asked to complete one questionnaire with knowledge test and satisfaction evaluation with the process of informed consent after the educational sessions.

    immediately after intervention

Study Arms (2)

control

NO INTERVENTION

video

EXPERIMENTAL
Other: video

Interventions

videoOTHER

The intervention group includes patients who obtain information about percutaneous cholecystostomy from a video will view at their bedside on a laptop.

video

Eligibility Criteria

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

You may qualify if:

  • All patients 18 years of age or older
  • scheduled to receive the percutaneous cholecystostomy

You may not qualify if:

  • clinically unstable
  • refuse to participate
  • are unable to understand the study process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807, Taiwan

Location

MeSH Terms

Conditions

Cholecystitis

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

August 1, 2011

First Posted

November 22, 2011

Study Start

November 9, 2009

Primary Completion

September 9, 2014

Study Completion

September 9, 2014

Last Updated

April 7, 2017

Record last verified: 2017-04

Locations

TW(1)