Clinical trial NCT04619030: Augmented Reality (AR): The Future of "Patient Information Leaflets
Official title: Augmented Reality (AR): The Future of "Patient Information Leaflets
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcoma
Breast Cancer
Cleft Lip and Palate
Surgical Flap
Keywords: patient information leaflet
augmented reality
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: The Glasgow School of Art
First posted: 2020-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised crossover
Primary purpose: OTHER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Mental Effort Rating Scale
timeFrame: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Secondary outcomes:
measure: Overall Patient Satisfaction
timeFrame: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
measure: Instructional Motivation Materials Survey
timeFrame: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
measure: Usefulness Scale for Patient Information (USE scale)
timeFrame: Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Other outcomes:
measure: Subjective interview
timeFrame: Single point at day 1 (Patient assesses leaflet once after reading both leaflets)
Locations:
city: Glasgow
country: United Kingdom
facility: Canniesburn Regional Plastic Surgery and Burns Unit
state: Scotland
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Children
state: Scotland
Study officials:
References: