NCT04619030

Brief Summary

This project aims to assess a new type of Augmented Reality Patient Information leaflet, in order to demonstrate that it is a beneficial information resource to patients when facing the diagnosis of sarcoma, breast cancer or to explain difficult concepts such as cleft lip repair. There are no published studies on the use of AR in patient leaflets.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

3 active sites

Status
unknown

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

November 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

November 2, 2020

Last Update Submit

June 7, 2021

Conditions

SarcomaBreast CancerCleft Lip and PalateSurgical Flap

Keywords

patient information leafletaugmented reality

Outcome Measures

Primary Outcomes (1)

  • Mental Effort Rating Scale

    Validated scale for cognitive load/ ease of understanding leaflet. Single item scale with rating 1 = very, very low mental effort to 9 = very, very high mental effort. Lower score is better

    Single point at day 1 (Patient assesses leaflet once after reading leaflet)

Secondary Outcomes (3)

  • Overall Patient Satisfaction

    Single point at day 1 (Patient assesses leaflet once after reading leaflet)

  • Instructional Motivation Materials Survey

    Single point at day 1 (Patient assesses leaflet once after reading leaflet)

  • Usefulness Scale for Patient Information (USE scale)

    Single point at day 1 (Patient assesses leaflet once after reading leaflet)

Other Outcomes (1)

  • Subjective interview

    Single point at day 1 (Patient assesses leaflet once after reading both leaflets)

Study Arms (2)

Augmented Reality Leaflet

EXPERIMENTAL

Patient Leaflet with Augmented reality component

Other: Augmented Reality

Traditional Leaflet

ACTIVE COMPARATOR

Traditional leaflet without Augmented Reality component

Other: Traditional leaflet

Interventions

Augmented RealityOTHER

The patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone

Augmented Reality Leaflet
Traditional leafletOTHER

Traditional leaflet with no Augmented Reality capability

Traditional Leaflet

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have undergone reconstructive surgery
  • patients who are awaiting reconstructive surgery
  • patients with sarcoma
  • patients with breast cancer
  • patients with reconstructive flaps
  • patients with or parents of patients with cleft lip and palate
  • Patients with dyslexia will be included

You may not qualify if:

  • Cannot speak or read English
  • Blind/severely visually impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Canniesburn Regional Plastic Surgery and Burns Unit

Glasgow, Scotland, G4 0SF, United Kingdom

RECRUITING

Glasgow Royal Infirmary

Glasgow, Scotland, G4 0SF, United Kingdom

RECRUITING

Royal Hospital for Children

Glasgow, Scotland, G51 4TF, United Kingdom

RECRUITING

Related Publications (1)

  • Lo SJ, Chapman P, Young D, Drake D, Devlin M, Russell C. The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet. Cleft Palate Craniofac J. 2023 Feb;60(2):179-188. doi: 10.1177/10556656211059709. Epub 2022 Jan 4.

    PMID: 34982018DERIVED

MeSH Terms

Conditions

SarcomaBreast NeoplasmsCleft Lip

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
It is not possible to blind participants to visual information in the patient leaflet (augmented reality versus traditional). The data collected will be fully anonymised before statistical assessment by an independent statistical service
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomised crossover
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 6, 2020

Study Start

November 30, 2020

Primary Completion

December 30, 2021

Study Completion

March 30, 2022

Last Updated

June 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

Available on reasonable written request following publication.

Shared Documents
STUDY PROTOCOL
Time Frame
Following publication and for 1 year
Access Criteria
Available on reasonable written request

Locations

GB(3)