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| Name | Class |
|---|---|
| The Glasgow School of Art | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented Reality Leaflet | Experimental | Patient Leaflet with Augmented reality component |
|
| Traditional Leaflet | Active Comparator | Traditional leaflet without Augmented Reality component |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented Reality | Other | The patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone |
|
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canniesburn Regional Plastic Surgery and Burns Unit | Recruiting | Glasgow | Scotland | G4 0SF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34982018 | Derived | Lo SJ, Chapman P, Young D, Drake D, Devlin M, Russell C. The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet. Cleft Palate Craniofac J. 2023 Feb;60(2):179-188. doi: 10.1177/10556656211059709. Epub 2022 Jan 4. |
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Available on reasonable written request following publication.
Following publication and for 1 year
Available on reasonable written request
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D001943 | Breast Neoplasms |
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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Randomised crossover
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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
| Traditional leaflet | Other | Traditional leaflet with no Augmented Reality capability |
|
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) |
| Glasgow Royal Infirmary | Recruiting | Glasgow | Scotland | G4 0SF | United Kingdom |
|
| Royal Hospital for Children | Recruiting | Glasgow | Scotland | G51 4TF | United Kingdom |
|
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |