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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619030
• Other study ID #: GN19HS442
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: May 2021
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Cleft Lip
• Cleft Lip and Palate
• Sarcoma
• Surgical Flap

Intervention

Other:
• Augmented Reality
The patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone
• Traditional leaflet
Traditional leaflet with no Augmented Reality capability

Locations

Country	Name	City	State
United Kingdom	Canniesburn Regional Plastic Surgery and Burns Unit	Glasgow	Scotland
United Kingdom	Glasgow Royal Infirmary	Glasgow	Scotland
United Kingdom	Royal Hospital for Children	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	The Glasgow School of Art

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)