Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598358
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Assessment of the Usabilityacceptability of the Little Journey App by Parentsguardianslegal Representatives and Children Aged Between 3-12 Years Old Who Have a Diagnosis of Autism Spectrum Disorder ASD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Little Journey - Usability Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Assessment of the usability acceptability of the Little Journey app with children aged between 3-12 years old with a diagnosis of autism spectrum disorder ASD and experience of attending hospital for a procedure and their parent or carer using a test scenario and semi-structured interview
Detailed Description:
Introduction
500000 children in the UK undergo outpatient surgery annually with 1 in 10 children having a neurodiversity diagnosis Children often find visits to hospital scary however neurodiverse chil-dren are twice as likely to experience anxiety and poorer outcomes Patient care does not cur-rently focus on preparing children for their hospital attendance instead focussing on distraction restraints and sedatives during their hospital visits
Little Journeys app intends to psychologically prepare children for their hospital visit and sub-sequently aims to reduce premedication rates on-the-day cancellations and pre-operative anxi-ety If effective this will bring cost-benefits for the NHS The app provides virtual tours of the rooms including surgical theatres ward areas and playrooms and age-tailored animations to describe the hospital-specific clinical pathway and procedures The app also provides relaxation activities and games for children and information articles fasting guidelines and checklists for their caregivers
Little Journey are developing an additional module named A Little About Me This module has several quizzes for children to complete including questions about how their communication preferences whats important to them what they like and how they feel about being in hospi-tal This is designed to support quicker relationship building between clinical staff and patients and enable support to be provided for neurodiverse children and their parents or carers Its important to have real end users provide feedback during the development of this module to support its optimisation for children with ASD
This study aims to assess the usability of the Little Journey app with 7 children and their parents or carers aged between 3-12 years with a diagnosis of ASD and experience of attending hospital for a procedure Children with an ASD diagnosis will be recruited from Birmingham Childrens Hospitals and their responding to recruitment flyers circulated via UHB and BCH staff channels and placed within the vicinity of Birmingham Childrens Hospital Interested and eligible indi-viduals will be invited to participate in a 60-minute session During the session participants will use the Little Journey app this will be recorded to film the child and parents or carers inter-action with the app The participants will then be asked to provide verbal feedback via a semi-structured interview
Study Rationale and Design Justification
Formative human factors usability testing is completed during the development of technologies to assess user interactions identify user errors and highlight areas of improvement before wide-spread use and adoption This study will be conducted in line with the international standard IECTR 62366-22016 guidance on the application of usability engineering to medical devices although the app is not a medical device the principles of usability testing are transferable to this study
This study researching the Little Journey app is being completed to support the softwares con-tinued co-development and improvement with particular focus on children with ASD and their parents or carers The study will provide opportunity for children with ASD and their parents or carers within a safe and controlled environment to interact with the user interface of the Little Journey app and provide qualitative feedback collected via a semi-structured interview This will be completed in a single visit and will take approximately 1 hour
Management of the usability acceptability study
The usability study conduct data management data analysis and study reporting will be under-taken by the NIHR HRC-DDR Team part of University Hospitals Birmingham NHS Foundation Trust A pseudo-anonymised report will be provided to Little Journey Ltd the study sponsor and developer of the Little Journey app
Participant Identification and Recruitment
The study participants will represent the intended users of the app 7 children with a diagnosis of ASD aged between 3-12- years old with previous experience of attending hospital for a procedure will be recruited Their parent or carer will be present throughout the study involvement
There will be two methods of recruiting individuals Firstly staff from BCH will screen potentially eligible individuals during their pre-admission checks children aged between 3 and 12 years old with ASD Potentially eligible individuals will be sent both the parent PIS and child PIS by a BCH staff member which will provide an overview of the study background their involvement and the benefits and risks of taking part If interest-ed in participating individuals will be asked to email or call the NIHR HRC-DDR Team who will then answer any questions about participating confirm eligibility and then schedule a study visit These contact details are included in the parent PIS
Secondly REC-approved recruitment flyers will be placed around the Birmingham Childrens Hospital site surrounding areas and circulated via staff channels at BCH and UHB Advertisements will signpost individuals to emailing or calling the NIHR HRC-DDR Team When a potential participant family member carer contacts the NIHR HRC-DDR team an electronic parent PIS and child PIS will be provided A member of the NIHR HRC-DDR team will answer any questions about participating confirm eligibility and then schedule a study visit
A limited database of name date they contacted the NIHR HRC-DDR means of contact which the potential participant provided and date the PIS was provided will be kept at NIHR HRC-DDR only for the purposes of contacting those individuals to provide further information If participants respond that they would not like to participate in the study their name and contact de-tails will be deleted
Once an interested participants parent has confirmed that they have read the PIS and are eligible to participate a study visit will be scheduled to take place within the Clinical Research Facility at Birmingham Children39s Hospital Participants will have at least 48 hours to consider the information in the child and parent carer PIS before being contacted by a member of the re-search team to see if they remain interested in taking part in the study or participating in the study
Participant Attendance
Individuals who are interested in participating in the study will contact the NIHR HRC-DDR They may be contacted by telephone or email thereafter to confirm their interest in participa-tion Prior to scheduling a study visit they will be asked to confirm that their child is eligible to participate and that they have read the participant information sheet Once confirmed a day will be scheduled to undertake the study
Participant Eligibility Confirmation
On attendance participants parents or carers will verbally confirm that the child being consented has an ASD diagnosis and experience of attending hospital for a procedure Individuals medical records will not be looked at by a member of the research team to confirm this Confirmation of eligibility will be recorded on the Eligibility Form All eligibility will need to be fulfilled to be consented into the study
When a subject fails to fulfil any element of the inclusion criteria the participant will be thanked for their time but not advanced into the study The partially completed eligibility form will be destroyed
The inclusion eligibility criteria are shown below
A diagnosis of autism spectrum disorder ASD
Aged between 3-12 years old
Experience of attending hospital for a procedure
Willing and able to participate in study including using an app and providing verbal feedback
Participant Informed Consent Process
At least 48 hours adequate time will be given for consideration by the participant before taking part The CI or an individual delegated by the CI must record when the Participant Information Sheet PIS has been given to the potential participant This provision will typically be done electronically with a hard copy at participant discretion Participants will have at least 48 hours to consider the information before being contacted by a member of the research team to see if they remain interested in taking part in the study or before participating in the study They will be asked if they meet the inclusion criteria and then either signposted to attend or thanked for their time and consideration If they are not eligible then all data including name contact details and date the PIS was sent will be deleted
Where a participant meets all elements of the inclusion criteria they will be invited to consent
It is the responsibility of the investigator or a suitable person delegated by the investigator to obtain informed consent prior to participation in the study This will follow an adequate explanation of the aims methods anticipated benefits and risk of the study to the child and the par-ent or carer The person taking consent will be GCP trained suitably qualified and experienced and have delegated authority from the CI on the delegation log The investigator or de-signee will explain that the participants are under no obligation to enter the study and that they can withdraw at any time during the study without having to give a reason
Parents or carers will confirm consent by completing the Informed Consent Form on behalf of themselves and their child The child will not be able to participate in the study without their parent consenting to both the participation of the child and themselves All children will be asked to complete an Assent Form with the assistance of a suitably trained member of staff following an adequate and age-appropriate explanation of the study Where the child is willing to participate but unable to complete the assent form due to age or ability and the parent or carer has completed the consent form on the childs behalf the child can still be enrolled in the study Their willingness to participate will be assessed verbally ie answering Yes when asked if they would like to take part pointing to the Yes columns on the Assent Form This will be recorded on the Assent Form If the child states that they would not like to take part we would not continue with their participation in the study
A copy of the signed informed consent form and assent form will be given to the participant on request The original signed forms will be retained by the NIHR HRC-DDR team at UHB
When a participant consents they will be allocated the next available study number subject ID number For enrolled participants this number will consist of the prefix LJ followed immediately by a sequential number 001 for the first subject 002 for the second subject and so on This number will be the unique identifier of the child and noted on the consent form and all other documentation relating to that individual
Timing of Recruitment
Participant recruitment will only commence when the study has been initiated by the Sponsor and Birmingham Childrens Hospital has issued the open to recruitment letter
Once the participant has confirmed eligibility and been consented to participate in the study the participant will be considered enrolled in the study
Duration of Study
Each participants study session is expected to take approximately 1 hour The study is anticipated to take 4-5 separate days and the entire duration of the study is anticipated to be 1 month
Methods
This study is a single-arm qualitative study assessing the usability of the Little Journey app in 7 children with an ASD diagnosis aged between 3-12 years The schedule is indicated in Table 1
Interested participants will be provided with Participant Information Sheets PIS for children and parentscarers which covers the essential information in the protocol the risks and benefits associated with taking part Participants will have at least 48 hours to consider the PIS before participating in the study The aforementioned consent process will be undertaken before participant enrolment and progression into the study
Training Explanation of the Little Journey App
A member of the research team will demonstrate how to use the app to the child and their parent or carer ensuring this is tailored to the age and ability of the child Prior to starting the task section of the session the child and their parent or carer will be asked if they are confident to complete the task by themselves If they do not feel confident further training demonstration will be provided by a member of the research team and there will be opportunity for the participant to walk through the tasks together speaking out loud the actions involved If the participant does not feel confident after second standard training cycle a member of the re-search team will assist throughout the task completion section of the usability session If the child and their parent or carer is confident the usability task session begins and support will be provided where required
Task Completion
A set of tasks Task List will be provided to the child and their parent or carer for completion The session will be moderated by a member of the research team who will guide the attendees through the tasks providing assistance where required This will allow the usability of the app as shown in Figure 1 to be assessed
The tasks are detailed in the Task List The tasks have been designed to utilise a range of the apps functionality with particular focus on the aspects which will be utilised by children with ASD This includes the below
1 Setting up the app
2 Taking a virtual tour of a hospital and accessing the age-tailored animations and information of a non-invasive hospital procedure
3 Completion of child quizzes related to their values likes and communication style
4 Completion of parent quizzes related to the needs and preferences of themselves and their child
5 Accessing the My Buddy character
The app will detail a fictional simulated non-invasive hospital procedure the description and detail of which has been tailored for children and uses animated characters The procedure will not be applicable to the participants current care to avoid the provision of conflicting information
The quizzes form part of the new A Little About Me ALAM module The child will be able to complete the ALAM questions using real or simulated answers dependent on their preferences It will be emphasised that this is a study to test how easy the app is to use and not to collect their data as this will have no implication on their future medical care These questions will include how the child likes to be communicated with what their child likes to do in their free time and how they feel about being in hospital The parent-facing quizzes focus on gaining additional information intended to enable better support provision from a hospital including how they feel about the child being in hospital and additional information about how the child feels about being in hospital and additional needs the child has
The task list will be used as a basis of the session and participants will be given an opportunity to use the Little Journey app as independently and naturally as possible without interference or influence from the research team However the session will be completed pragmatically de-pendent on the age and ability of the child This will be guided by the participant and their par-ent as well as paediatric trained clinical staff at Birmingham Childrens Hospital As a result not all elements of all tasks may be completed during each session
Observation
The sessions will be recorded using a video camera This footage will focus on the participants interaction with the app The screen of the device will be captured which will allow use of the app to be assessed This video footage will be edited following the sessions by the NIHR HRC-DDR Team and provided to Little Journey for the uses outlined in the Informed Consent Form
Semi-structured Interview
Following completion of the task section of the session the child and their parent or carer will be asked the questions outlined in the Semi-Structured Interview Questions document These questions focus on the acceptability and usability of the Little Journey app These questions will form the basis of the interview however further questions may be asked based on the use of the app in the session or feedback provided by the child and their parent or carer The questions may be tailored to suit the age and ability of the child however all questions will remain focused on the usability and acceptability of the Little Journey app
The interview will be audio recorded to allow the interviews to be captured and later transcribed ahead of qualitative analysis These recordings will only be available to members of the NIHR HRC-DDR Team as required for transcription and analysis
Protecting human subjects and participants rights
The topmost requirement of the formative human factor test is to ensure that none of the participants suffer physically or emotionally Every participant is free to join and also to leave the test at any time For assurance that every participant is aware of their rights every participant will be provided with a participant information sheet at least 48 hours prior to their participation Additionally the participant information sheets will be discussed with the child and their parent or carer before they are consented into the study
Participants will be asked to remove any identifiable items to maintain their privacy When requested the participants faces may be censored in the video recordings using face tracking pixilation software Participants not wishing video recordings to be made or released outside of the study team should indicate this before the study or via a request made within 48 hours of participation If requested the video footage will be permanently deleted
Video footage collected from the study will be edited and sent to Little Journey via a protected Vimeo link for download
Risks
Emotional distress The risk of any emotional distress has been reduced as far as possible The study will not be specific to the childs medical care The app will detail a fictional simulated non-invasive hospital procedure the description and detail of which has been tailored for chil-dren and uses animated characters Paediatric participants will be accompanied by a parent or carer for the duration of their participation in the study in addition to trained paediatric healthcare professionals The child and parent or carer will be able to take a break or stop taking part at any point of the study We therefore believe that the risk of emotional distress or upset is low
Benefits
The study will not change how any children in the study will be looked after in hospital and therefore have no direct benefits to participants However the feedback collected as part of the study will be used by Little Journey to further co-develop and improve the app which may improve the ease of use and accessibility of the Little Journey app This may lead to reduced pre-hospital anxiety in parents and children and improved hospital experiences in the future
Participants will be provided with a 50 Love2Shop voucher to reimburse them for their time and any travel expenses will also be reimbursed
Data Analysis and Management
All study documentation will be kept by the NIHR HRC-DDR team and stored at UHB until archived in line with UHBs archiving policy If participants withdraw from the study all documentation except the participants consent forms will be destroyed
The semi-structured interviews will be transcribed by the NIHR HRC-DDR Team Following this the team will complete thematic analysis to identify key themes feedback and recommendations Thematic analysis will matrix the data so feedback is linked to particular elements and features of the Little Journey app The themes selected from the interviews and video footage will be agreed by at least 3 members of the NIHR HRC-DDR Team all with previous experience of conducting qualitative thematic analysis for human factors usability studies A report summa-rising the information collected by participants will be written into a report and provided to the Little Journey team with the aim of supporting continued co-development and improvement of the Little Journey app with particular consideration to the accessibility of the App for children with diagnosed Autism
Recorded video footage will be reviewed and edited by the NIHR HRC-DDR Team The edited video footage will be provided to Little Journey via a protected Vimeo link this can be down-loaded by Little Journey and used for the purposes outlined in the AV consent form Partici-pants will be asked to remove any identifiable insignia before participating in the study and the footage will be edited so participants in the video are not linked to their study number
Confidentiality
All data will be handled in accordance with the UK Data Protection Act 2018 and GDPR The semi-structured interview forms and eligibility forms will not bear the participants names or other identifiable information The participants study identification number will be used for identification and this will be clearly explained in the Participant Information Sheet
Record Keeping and Archiving
At the end of the study any personal identifiable data will be kept securely at UHB for 3 months All essential documentation will be archived for 5 years from the declaration of end of study in line with UHBs archiving policy UHB will inform the Little Journey Sponsor if the lo-cation of the study document archive is changed
Essential documents are those which enable both the conduct of the study and the quality of the data produced to be evaluated and show whether the site complied with all applicable regulatory requirements All archived documents must continue to be available for inspection by appropriate authorities upon request
Statistical Considerations
Sample Size International standard IECTR 62366-22016 guidance on the application of usability engineer-ing to medical devices states that many usability defects can be found with same sizes between five to eight participants It also notes that small sample sizes can be used to satisfactorily identify usability defects with six participants having a usability problem cumulative probability of 082 Additionally there will be no comparison with other technologies which would necessitate a larger sample size As a result 7 participants will be recruited to the study To note the Little Journey app is not a medical device however the key principles of usability testing and co-development outlined in this standard are transferable to this research
Insurance
The Sponsor holds insurance against claims from participants for injury caused by their participation in the study Participants may be able to claim compensation if they can prove negligence University Hospitals Birmingham Birmingham Childrens Hospital does not accept liability for any breach in the hospitals duty of care or any negligence on the part of hospital employees
500000 children in the UK undergo outpatient surgery annually with 1 in 10 children having a neurodiversity diagnosis Children often find visits to hospital scary however neurodiverse chil-dren are twice as likely to experience anxiety and poorer outcomes Patient care does not cur-rently focus on preparing children for their hospital attendance instead focussing on distraction restraints and sedatives during their hospital visits
Little Journeys app intends to psychologically prepare children for their hospital visit and sub-sequently aims to reduce premedication rates on-the-day cancellations and pre-operative anxi-ety If effective this will bring cost-benefits for the NHS The app provides virtual tours of the rooms including surgical theatres ward areas and playrooms and age-tailored animations to describe the hospital-specific clinical pathway and procedures The app also provides relaxation activities and games for children and information articles fasting guidelines and checklists for their caregivers
Little Journey are developing an additional module named A Little About Me This module has several quizzes for children to complete including questions about how their communication preferences whats important to them what they like and how they feel about being in hospi-tal This is designed to support quicker relationship building between clinical staff and patients and enable support to be provided for neurodiverse children and their parents or carers Its important to have real end users provide feedback during the development of this module to support its optimisation for children with ASD
This study aims to assess the usability of the Little Journey app with 7 children and their parents or carers aged between 3-12 years with a diagnosis of ASD and experience of attending hospital for a procedure Children with an ASD diagnosis will be recruited from Birmingham Childrens Hospitals and their responding to recruitment flyers circulated via UHB and BCH staff channels and placed within the vicinity of Birmingham Childrens Hospital Interested and eligible indi-viduals will be invited to participate in a 60-minute session During the session participants will use the Little Journey app this will be recorded to film the child and parents or carers inter-action with the app The participants will then be asked to provide verbal feedback via a semi-structured interview
Study Rationale and Design Justification
Formative human factors usability testing is completed during the development of technologies to assess user interactions identify user errors and highlight areas of improvement before wide-spread use and adoption This study will be conducted in line with the international standard IECTR 62366-22016 guidance on the application of usability engineering to medical devices although the app is not a medical device the principles of usability testing are transferable to this study
This study researching the Little Journey app is being completed to support the softwares con-tinued co-development and improvement with particular focus on children with ASD and their parents or carers The study will provide opportunity for children with ASD and their parents or carers within a safe and controlled environment to interact with the user interface of the Little Journey app and provide qualitative feedback collected via a semi-structured interview This will be completed in a single visit and will take approximately 1 hour
Management of the usability acceptability study
The usability study conduct data management data analysis and study reporting will be under-taken by the NIHR HRC-DDR Team part of University Hospitals Birmingham NHS Foundation Trust A pseudo-anonymised report will be provided to Little Journey Ltd the study sponsor and developer of the Little Journey app
Participant Identification and Recruitment
The study participants will represent the intended users of the app 7 children with a diagnosis of ASD aged between 3-12- years old with previous experience of attending hospital for a procedure will be recruited Their parent or carer will be present throughout the study involvement
There will be two methods of recruiting individuals Firstly staff from BCH will screen potentially eligible individuals during their pre-admission checks children aged between 3 and 12 years old with ASD Potentially eligible individuals will be sent both the parent PIS and child PIS by a BCH staff member which will provide an overview of the study background their involvement and the benefits and risks of taking part If interest-ed in participating individuals will be asked to email or call the NIHR HRC-DDR Team who will then answer any questions about participating confirm eligibility and then schedule a study visit These contact details are included in the parent PIS
Secondly REC-approved recruitment flyers will be placed around the Birmingham Childrens Hospital site surrounding areas and circulated via staff channels at BCH and UHB Advertisements will signpost individuals to emailing or calling the NIHR HRC-DDR Team When a potential participant family member carer contacts the NIHR HRC-DDR team an electronic parent PIS and child PIS will be provided A member of the NIHR HRC-DDR team will answer any questions about participating confirm eligibility and then schedule a study visit
A limited database of name date they contacted the NIHR HRC-DDR means of contact which the potential participant provided and date the PIS was provided will be kept at NIHR HRC-DDR only for the purposes of contacting those individuals to provide further information If participants respond that they would not like to participate in the study their name and contact de-tails will be deleted
Once an interested participants parent has confirmed that they have read the PIS and are eligible to participate a study visit will be scheduled to take place within the Clinical Research Facility at Birmingham Children39s Hospital Participants will have at least 48 hours to consider the information in the child and parent carer PIS before being contacted by a member of the re-search team to see if they remain interested in taking part in the study or participating in the study
Participant Attendance
Individuals who are interested in participating in the study will contact the NIHR HRC-DDR They may be contacted by telephone or email thereafter to confirm their interest in participa-tion Prior to scheduling a study visit they will be asked to confirm that their child is eligible to participate and that they have read the participant information sheet Once confirmed a day will be scheduled to undertake the study
Participant Eligibility Confirmation
On attendance participants parents or carers will verbally confirm that the child being consented has an ASD diagnosis and experience of attending hospital for a procedure Individuals medical records will not be looked at by a member of the research team to confirm this Confirmation of eligibility will be recorded on the Eligibility Form All eligibility will need to be fulfilled to be consented into the study
When a subject fails to fulfil any element of the inclusion criteria the participant will be thanked for their time but not advanced into the study The partially completed eligibility form will be destroyed
The inclusion eligibility criteria are shown below
A diagnosis of autism spectrum disorder ASD
Aged between 3-12 years old
Experience of attending hospital for a procedure
Willing and able to participate in study including using an app and providing verbal feedback
Participant Informed Consent Process
At least 48 hours adequate time will be given for consideration by the participant before taking part The CI or an individual delegated by the CI must record when the Participant Information Sheet PIS has been given to the potential participant This provision will typically be done electronically with a hard copy at participant discretion Participants will have at least 48 hours to consider the information before being contacted by a member of the research team to see if they remain interested in taking part in the study or before participating in the study They will be asked if they meet the inclusion criteria and then either signposted to attend or thanked for their time and consideration If they are not eligible then all data including name contact details and date the PIS was sent will be deleted
Where a participant meets all elements of the inclusion criteria they will be invited to consent
It is the responsibility of the investigator or a suitable person delegated by the investigator to obtain informed consent prior to participation in the study This will follow an adequate explanation of the aims methods anticipated benefits and risk of the study to the child and the par-ent or carer The person taking consent will be GCP trained suitably qualified and experienced and have delegated authority from the CI on the delegation log The investigator or de-signee will explain that the participants are under no obligation to enter the study and that they can withdraw at any time during the study without having to give a reason
Parents or carers will confirm consent by completing the Informed Consent Form on behalf of themselves and their child The child will not be able to participate in the study without their parent consenting to both the participation of the child and themselves All children will be asked to complete an Assent Form with the assistance of a suitably trained member of staff following an adequate and age-appropriate explanation of the study Where the child is willing to participate but unable to complete the assent form due to age or ability and the parent or carer has completed the consent form on the childs behalf the child can still be enrolled in the study Their willingness to participate will be assessed verbally ie answering Yes when asked if they would like to take part pointing to the Yes columns on the Assent Form This will be recorded on the Assent Form If the child states that they would not like to take part we would not continue with their participation in the study
A copy of the signed informed consent form and assent form will be given to the participant on request The original signed forms will be retained by the NIHR HRC-DDR team at UHB
When a participant consents they will be allocated the next available study number subject ID number For enrolled participants this number will consist of the prefix LJ followed immediately by a sequential number 001 for the first subject 002 for the second subject and so on This number will be the unique identifier of the child and noted on the consent form and all other documentation relating to that individual
Timing of Recruitment
Participant recruitment will only commence when the study has been initiated by the Sponsor and Birmingham Childrens Hospital has issued the open to recruitment letter
Once the participant has confirmed eligibility and been consented to participate in the study the participant will be considered enrolled in the study
Duration of Study
Each participants study session is expected to take approximately 1 hour The study is anticipated to take 4-5 separate days and the entire duration of the study is anticipated to be 1 month
Methods
This study is a single-arm qualitative study assessing the usability of the Little Journey app in 7 children with an ASD diagnosis aged between 3-12 years The schedule is indicated in Table 1
Interested participants will be provided with Participant Information Sheets PIS for children and parentscarers which covers the essential information in the protocol the risks and benefits associated with taking part Participants will have at least 48 hours to consider the PIS before participating in the study The aforementioned consent process will be undertaken before participant enrolment and progression into the study
Training Explanation of the Little Journey App
A member of the research team will demonstrate how to use the app to the child and their parent or carer ensuring this is tailored to the age and ability of the child Prior to starting the task section of the session the child and their parent or carer will be asked if they are confident to complete the task by themselves If they do not feel confident further training demonstration will be provided by a member of the research team and there will be opportunity for the participant to walk through the tasks together speaking out loud the actions involved If the participant does not feel confident after second standard training cycle a member of the re-search team will assist throughout the task completion section of the usability session If the child and their parent or carer is confident the usability task session begins and support will be provided where required
Task Completion
A set of tasks Task List will be provided to the child and their parent or carer for completion The session will be moderated by a member of the research team who will guide the attendees through the tasks providing assistance where required This will allow the usability of the app as shown in Figure 1 to be assessed
The tasks are detailed in the Task List The tasks have been designed to utilise a range of the apps functionality with particular focus on the aspects which will be utilised by children with ASD This includes the below
1 Setting up the app
2 Taking a virtual tour of a hospital and accessing the age-tailored animations and information of a non-invasive hospital procedure
3 Completion of child quizzes related to their values likes and communication style
4 Completion of parent quizzes related to the needs and preferences of themselves and their child
5 Accessing the My Buddy character
The app will detail a fictional simulated non-invasive hospital procedure the description and detail of which has been tailored for children and uses animated characters The procedure will not be applicable to the participants current care to avoid the provision of conflicting information
The quizzes form part of the new A Little About Me ALAM module The child will be able to complete the ALAM questions using real or simulated answers dependent on their preferences It will be emphasised that this is a study to test how easy the app is to use and not to collect their data as this will have no implication on their future medical care These questions will include how the child likes to be communicated with what their child likes to do in their free time and how they feel about being in hospital The parent-facing quizzes focus on gaining additional information intended to enable better support provision from a hospital including how they feel about the child being in hospital and additional information about how the child feels about being in hospital and additional needs the child has
The task list will be used as a basis of the session and participants will be given an opportunity to use the Little Journey app as independently and naturally as possible without interference or influence from the research team However the session will be completed pragmatically de-pendent on the age and ability of the child This will be guided by the participant and their par-ent as well as paediatric trained clinical staff at Birmingham Childrens Hospital As a result not all elements of all tasks may be completed during each session
Observation
The sessions will be recorded using a video camera This footage will focus on the participants interaction with the app The screen of the device will be captured which will allow use of the app to be assessed This video footage will be edited following the sessions by the NIHR HRC-DDR Team and provided to Little Journey for the uses outlined in the Informed Consent Form
Semi-structured Interview
Following completion of the task section of the session the child and their parent or carer will be asked the questions outlined in the Semi-Structured Interview Questions document These questions focus on the acceptability and usability of the Little Journey app These questions will form the basis of the interview however further questions may be asked based on the use of the app in the session or feedback provided by the child and their parent or carer The questions may be tailored to suit the age and ability of the child however all questions will remain focused on the usability and acceptability of the Little Journey app
The interview will be audio recorded to allow the interviews to be captured and later transcribed ahead of qualitative analysis These recordings will only be available to members of the NIHR HRC-DDR Team as required for transcription and analysis
Protecting human subjects and participants rights
The topmost requirement of the formative human factor test is to ensure that none of the participants suffer physically or emotionally Every participant is free to join and also to leave the test at any time For assurance that every participant is aware of their rights every participant will be provided with a participant information sheet at least 48 hours prior to their participation Additionally the participant information sheets will be discussed with the child and their parent or carer before they are consented into the study
Participants will be asked to remove any identifiable items to maintain their privacy When requested the participants faces may be censored in the video recordings using face tracking pixilation software Participants not wishing video recordings to be made or released outside of the study team should indicate this before the study or via a request made within 48 hours of participation If requested the video footage will be permanently deleted
Video footage collected from the study will be edited and sent to Little Journey via a protected Vimeo link for download
Risks
Emotional distress The risk of any emotional distress has been reduced as far as possible The study will not be specific to the childs medical care The app will detail a fictional simulated non-invasive hospital procedure the description and detail of which has been tailored for chil-dren and uses animated characters Paediatric participants will be accompanied by a parent or carer for the duration of their participation in the study in addition to trained paediatric healthcare professionals The child and parent or carer will be able to take a break or stop taking part at any point of the study We therefore believe that the risk of emotional distress or upset is low
Benefits
The study will not change how any children in the study will be looked after in hospital and therefore have no direct benefits to participants However the feedback collected as part of the study will be used by Little Journey to further co-develop and improve the app which may improve the ease of use and accessibility of the Little Journey app This may lead to reduced pre-hospital anxiety in parents and children and improved hospital experiences in the future
Participants will be provided with a 50 Love2Shop voucher to reimburse them for their time and any travel expenses will also be reimbursed
Data Analysis and Management
All study documentation will be kept by the NIHR HRC-DDR team and stored at UHB until archived in line with UHBs archiving policy If participants withdraw from the study all documentation except the participants consent forms will be destroyed
The semi-structured interviews will be transcribed by the NIHR HRC-DDR Team Following this the team will complete thematic analysis to identify key themes feedback and recommendations Thematic analysis will matrix the data so feedback is linked to particular elements and features of the Little Journey app The themes selected from the interviews and video footage will be agreed by at least 3 members of the NIHR HRC-DDR Team all with previous experience of conducting qualitative thematic analysis for human factors usability studies A report summa-rising the information collected by participants will be written into a report and provided to the Little Journey team with the aim of supporting continued co-development and improvement of the Little Journey app with particular consideration to the accessibility of the App for children with diagnosed Autism
Recorded video footage will be reviewed and edited by the NIHR HRC-DDR Team The edited video footage will be provided to Little Journey via a protected Vimeo link this can be down-loaded by Little Journey and used for the purposes outlined in the AV consent form Partici-pants will be asked to remove any identifiable insignia before participating in the study and the footage will be edited so participants in the video are not linked to their study number
Confidentiality
All data will be handled in accordance with the UK Data Protection Act 2018 and GDPR The semi-structured interview forms and eligibility forms will not bear the participants names or other identifiable information The participants study identification number will be used for identification and this will be clearly explained in the Participant Information Sheet
Record Keeping and Archiving
At the end of the study any personal identifiable data will be kept securely at UHB for 3 months All essential documentation will be archived for 5 years from the declaration of end of study in line with UHBs archiving policy UHB will inform the Little Journey Sponsor if the lo-cation of the study document archive is changed
Essential documents are those which enable both the conduct of the study and the quality of the data produced to be evaluated and show whether the site complied with all applicable regulatory requirements All archived documents must continue to be available for inspection by appropriate authorities upon request
Statistical Considerations
Sample Size International standard IECTR 62366-22016 guidance on the application of usability engineer-ing to medical devices states that many usability defects can be found with same sizes between five to eight participants It also notes that small sample sizes can be used to satisfactorily identify usability defects with six participants having a usability problem cumulative probability of 082 Additionally there will be no comparison with other technologies which would necessitate a larger sample size As a result 7 participants will be recruited to the study To note the Little Journey app is not a medical device however the key principles of usability testing and co-development outlined in this standard are transferable to this research
Insurance
The Sponsor holds insurance against claims from participants for injury caused by their participation in the study Participants may be able to claim compensation if they can prove negligence University Hospitals Birmingham Birmingham Childrens Hospital does not accept liability for any breach in the hospitals duty of care or any negligence on the part of hospital employees
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None