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

Not Applicable

• Conditions: Breast Cancer; Sarcoma; Surgical Flap; Cleft Lip and Palate
• Interventions: Other: Traditional leaflet; Other: Augmented Reality

• Registration Number: NCT04619030
• Lead Sponsor: NHS Greater Glasgow and Clyde

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.

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 Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Study Start: 2020-11-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-10
• Primary Completion: 2021-12-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Traditional Leaflet	Traditional leaflet	Traditional leaflet without Augmented Reality component
Augmented Reality Leaflet	Augmented Reality	Patient Leaflet with Augmented reality component

Primary Outcome Measures

Name	Time	Method
Mental Effort Rating Scale	Single point at day 1 (Patient assesses leaflet once after reading leaflet)	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

Secondary Outcome Measures

Name	Time	Method
Instructional Motivation Materials Survey	Single point at day 1 (Patient assesses leaflet once after reading leaflet)	Assessment of patient learning motivation after reading leaflet. 36 items, each item rated by Likert scale 1-5. Higher score is better.
Overall Patient Satisfaction	Single point at day 1 (Patient assesses leaflet once after reading leaflet)	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
Usefulness Scale for Patient Information (USE scale)	Single point at day 1 (Patient assesses leaflet once after reading leaflet)	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.

Trial Locations

Locations (3)

Royal Hospital for Children; 🇬🇧 Glasgow, Scotland, United Kingdom

Canniesburn Regional Plastic Surgery and Burns Unit; 🇬🇧 Glasgow, Scotland, United Kingdom

Glasgow Royal Infirmary; 🇬🇧 Glasgow, Scotland, United Kingdom