NCT04048538

Brief Summary

This randomized control trial will compare traditional patient education methods (pamphlets, clinical visits) to the implementation of an innovated patient education platform. The purpose of the project is to determine whether the use of this animation based patient education platform prior to undergoing surgery will lead to improved patient satisfaction and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

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

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

August 6, 2019

Last Update Submit

October 15, 2021

Conditions

Keywords

patient educationsurgical educationmultimediaanimationguide

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    analyzed using patient questionnaire responses

    1 month post-operative

Secondary Outcomes (1)

  • Post-operative complication rate

    1 month post-operative

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Individuals who will receive access to the animated multimedia platform prior to their surgical procedure.

Other: Precare

Control Arm

ACTIVE COMPARATOR

Individuals who will not receive access to the animated patient platform, and instead will receive the usual standard of care.

Other: usual standard of care

Interventions

PrecareOTHER

an innovative patient education platform using animated videos created by using up-to-date evidence-based informaiton

Treatment Arm

individuals will receive treatment as per the usual standard of care

Control Arm

Eligibility Criteria

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

You may qualify if:

  • Individuals having any of the following surgical procedure at the Jewish General Hospital over the next 12 months: head and neck cancer resection with or without reconstruction, excision of parotid lesion, thyroidectomy, parathyroidectomy, laryngectomy, or trans-oral robotic resection.

You may not qualify if:

  • Individuals who are undergoing a surgical procedure not included in the ones listed above, or those who are having revision surgery or have previously had surgery in the otolaryngology, head and neck surgery department.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

  • Turkdogan S, Roy CF, Chartier G, Payne R, Mlynarek A, Forest VI, Hier M. Effect of Perioperative Patient Education via Animated Videos in Patients Undergoing Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Feb 1;148(2):173-179. doi: 10.1001/jamaoto.2021.3765.

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 7, 2019

Study Start

September 1, 2019

Primary Completion

December 30, 2020

Study Completion

January 30, 2021

Last Updated

October 18, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations