Augmented Reality (AR): The Future of "Patient Information Leaflets
Primary Purpose
Sarcoma, Breast Cancer, Cleft Lip and Palate
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Augmented Reality
Traditional leaflet
Sponsored by
About this trial
This is an interventional other trial for Sarcoma focused on measuring patient information leaflet, augmented reality
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
Sites / Locations
- Canniesburn Regional Plastic Surgery and Burns UnitRecruiting
- Glasgow Royal InfirmaryRecruiting
- Royal Hospital for ChildrenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Augmented Reality Leaflet
Traditional Leaflet
Arm Description
Patient Leaflet with Augmented reality component
Traditional leaflet without Augmented Reality component
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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.
Full Information
NCT ID
NCT04619030
First Posted
November 2, 2020
Last Updated
June 7, 2021
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
The Glasgow School of Art
1. Study Identification
Unique Protocol Identification Number
NCT04619030
Brief Title
Augmented Reality (AR): The Future of "Patient Information Leaflets
Official Title
Augmented Reality (AR): The Future of "Patient Information Leaflets
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
The Glasgow School of Art
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Breast Cancer, Cleft Lip and Palate, Surgical Flap
Keywords
patient information leaflet, augmented reality
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised crossover
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Augmented Reality Leaflet
Arm Type
Experimental
Arm Description
Patient Leaflet with Augmented reality component
Arm Title
Traditional Leaflet
Arm Type
Active Comparator
Arm Description
Traditional leaflet without Augmented Reality component
Intervention Type
Other
Intervention Name(s)
Augmented Reality
Intervention Description
The patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone
Intervention Type
Other
Intervention Name(s)
Traditional leaflet
Intervention Description
Traditional leaflet with no Augmented Reality capability
Primary Outcome Measure Information:
Title
Mental Effort Rating Scale
Description
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
Time Frame
Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Secondary Outcome Measure Information:
Title
Overall Patient Satisfaction
Description
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
Time Frame
Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Title
Instructional Motivation Materials Survey
Description
Assessment of patient learning motivation after reading leaflet. 36 items, each item rated by Likert scale 1-5. Higher score is better.
Time Frame
Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Title
Usefulness Scale for Patient Information (USE scale)
Description
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.
Time Frame
Single point at day 1 (Patient assesses leaflet once after reading leaflet)
Other Pre-specified Outcome Measures:
Title
Subjective interview
Description
Patients will be interviewed regarding opinions of the two types of patient leaflet.
Time Frame
Single point at day 1 (Patient assesses leaflet once after reading both leaflets)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Canniesburn Regional Plastic Surgery and Burns Unit
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Lo, FRCS Plast
Phone
0141 2114000
Ext
4475
Email
steven.lo@nhs.net
First Name & Middle Initial & Last Name & Degree
David McGill, FRCS Plast
Phone
0141 211 4000
Facility Name
Glasgow Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Lo
Phone
01412114000
Email
Steven.lo@ggc.scot.nhs.uk
Facility Name
Royal Hospital for Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Lo
Phone
01412114000
Email
Steven.lo@ggc.scot.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Available on reasonable written request following publication.
IPD Sharing Time Frame
Following publication and for 1 year
IPD Sharing Access Criteria
Available on reasonable written request
Learn more about this trial
Augmented Reality (AR): The Future of "Patient Information Leaflets
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