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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04619030
Enrollment
20
Registered
2020-11-06
Start date
2020-11-30
Completion date
2022-03-30
Last updated
2021-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

patient information leaflet, augmented reality

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).

Interventions

OTHERAugmented Reality

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

OTHERTraditional leaflet

Traditional leaflet with no Augmented Reality capability

Sponsors

The Glasgow School of Art
CollaboratorUNKNOWN
NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

Randomised crossover

Eligibility

Sex/Gender
ALL
Age
16 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mental Effort Rating ScaleSingle 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

MeasureTime frameDescription
Overall Patient SatisfactionSingle 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
Instructional Motivation Materials SurveySingle 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.
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.

Other

MeasureTime frameDescription
Subjective interviewSingle point at day 1 (Patient assesses leaflet once after reading both leaflets)Patients will be interviewed regarding opinions of the two types of patient leaflet.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026