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

Study Overview
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Brief Summary
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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
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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).

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

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

Intervention / Treatment
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* Other: Augmented Reality
* Other: Traditional leaflet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomised crossover
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient information leaflet, augmented reality