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

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ClinicalTrials.gov Identifier: NCT04619030
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : June 10, 2021
Sponsor:
Collaborator:
The Glasgow School of Art
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcoma Breast Cancer Cleft Lip and Palate Surgical Flap Other: Augmented Reality Other: Traditional leaflet Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomised crossover
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
Primary Purpose: Other
Official Title: Augmented Reality (AR): The Future of "Patient Information Leaflets
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Augmented Reality Leaflet
Patient Leaflet with Augmented reality component
 Other: Augmented Reality
The patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone
Active Comparator: Traditional Leaflet
Traditional leaflet without Augmented Reality component
 Other: Traditional leaflet
Traditional leaflet with no Augmented Reality capability


Outcome Measures
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Primary Outcome Measures :
  1. Mental Effort Rating Scale [ Time Frame: Single 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 Outcome Measures :
  1. Overall Patient Satisfaction [ Time Frame: Single 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

  2. Instructional Motivation Materials Survey [ Time Frame: Single 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.

  3. Usefulness Scale for Patient Information (USE scale) [ Time Frame: 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 Outcome Measures:
  1. Subjective interview [ Time Frame: Single 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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04619030


Locations
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United Kingdom
Canniesburn Regional Plastic Surgery and Burns Unit Recruiting
Glasgow, Scotland, United Kingdom, G4 0SF
Contact: Steven Lo, FRCS Plast    0141 2114000 ext 4475    steven.lo@nhs.net   
Contact: David McGill, FRCS Plast    0141 211 4000      
Glasgow Royal Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G4 0SF
Contact: Steven Lo    01412114000    Steven.lo@ggc.scot.nhs.uk   
Royal Hospital for Children Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Contact: Steven Lo    01412114000    Steven.lo@ggc.scot.nhs.uk   
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
The Glasgow School of Art
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04619030    
Other Study ID Numbers: GN19HS442
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Available on reasonable written request following publication.
Supporting Materials: Study Protocol
Time Frame: Following publication and for 1 year
Access Criteria: Available on reasonable written request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Greater Glasgow and Clyde:
patient information leaflet
augmented reality
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
 Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities