Augmented Reality (AR): The Future of "Patient Information Leaflets

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma; Breast Cancer; Cleft Lip and Palate; Surgical Flap
• Intervention / Treatment: Other: Augmented Reality; Other: Traditional leaflet

Detailed Description

At present, the traditional approach to patient education regarding diseases such as a new cancer diagnosis, is the patient information leaflet. Patient information leaflets often fail to convey the required medical information due to poor levels of literacy in the population, with 20% patients in the UK having the lowest level of adult literacy (equivalent to an individual who is unable to determine how much medicine to give a child from information printed on the package). "Health literacy" - the ability to obtain, understand, act on and communicate health information - is even lower, with estimates that 40% of patients have inadequate levels of health literacy. Additionally, there is a large knowledge gap between what doctors perceive patients understand about an illness, medication, or operation, and what patients actually comprehend and retain during consultation.

The plethora of problems of inadequate information, poor health literacy and patient-doctor knowledge disconnect, may be addressed with an approach to patient information leaflets using a platform that is entirely simulative and visual, thereby overcoming the problem of health literacy. The study builds upon pilot work by this research team on patient leaflets using AR to aid in patient education, visualisation and retention of information (Lo et al 2019).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G51 4TF
      • Recruiting
      • Royal Hospital For Children
      • Contact: Steven Lo; Phone Number: 01412114000; Email: Steven.lo@ggc.scot.nhs.uk
    • Glasgow, Scotland, United Kingdom, G4 0SF
      • Recruiting
      • Glasgow Royal Infirmary
      • Contact: Steven Lo; Phone Number: 01412114000; Email: Steven.lo@ggc.scot.nhs.uk
    • Glasgow, Scotland, United Kingdom, G4 0SF
      • Recruiting
      • Canniesburn Regional Plastic Surgery and Burns Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented Reality Leaflet; Patient Leaflet with Augmented reality component	Other: Augmented Reality; The patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone
Active Comparator: Traditional Leaflet; Traditional leaflet without Augmented Reality component	Other: Traditional leaflet; Traditional leaflet with no Augmented Reality capability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Patient Satisfaction	Visual analogue scale, overall satisfaction with patient leaflet. Visual analogue scale will be converted to numerical scale 0-100, with higher being better or more satisfied	Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Instructional Motivation Materials Survey	Assessment of patient learning motivation after reading leaflet. 36 items, each item rated by Likert scale 1-5. Higher score is better.	Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Usefulness Scale for Patient Information (USE scale)	9 item scale with Likert rating 0-10 for each item. Total score out of 90, with 3 sub scales measuring cognitive, emotional and behavioural dimensions. Higher score is better.	Single point at day 1 (Patient assesses leaflet once after reading leaflet)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective interview	Patients will be interviewed regarding opinions of the two types of patient leaflet.	Single point at day 1 (Patient assesses leaflet once after reading both leaflets)

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: The Glasgow School of Art

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): March 30, 2022

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: augmented reality; patient information leaflet
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: GN19HS442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available on reasonable written request following publication.
• IPD Sharing Time Frame: Following publication and for 1 year
• IPD Sharing Access Criteria: Available on reasonable written request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No