Chatbot for young people with type 1 diabetes mellitus
| ISRCTN | ISRCTN15525627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15525627 |
| IRAS number | 092053 |
| Secondary identifying numbers | CPMS 49396, NIHR201629, IRAS 092053 |
- Submission date
- 02/08/2021
- Registration date
- 15/02/2022
- Last edited
- 01/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Type 1 diabetes causes the level of glucose (sugar) in your blood to become too high. It happens when your body cannot produce enough of a hormone called insulin, which controls blood glucose. You need daily injections of insulin to keep your blood glucose levels under control.
Our team of doctors, nurses, young people (YP), parents/guardians, researchers, and technologists plan to create a new way of helping YP with type 1 diabetes to become confident at self-managing their diabetes when they move (‘transition’) from children’s to adult healthcare. To do this, we will develop a YP friendly diabetes chatbot (software for online chat), with avatars and linked videos.
Who can participate?
YP aged 11-25 years with type 1 diabetes
What does the study involve?
In this project, we will first ask participants to take part in a focus group, interview, or workshop to help us develop the chatbot and extra materials. We will also ask health professionals to take part in a focus group.
Once the chatbot is ready, we will ask 40 YP aged 11-25 years with diabetes to use the chatbot on a mobile phone or DigiBete website (https://www.digibete.org/) for 6 weeks. We will ask them to fill in online questionnaires before, during, and after the 6-week trial. We will also ask them to take part in an interview after the trial to tell us what they thought about using the chatbot.
What are the possible benefits and risks of participating?
Participants may enjoy talking about their experiences of diabetes with other young people, hearing about other people's experiences of living with and managing type 1 diabetes, as well as actively contributing to the creation of a valuable resource that will help others in the future. Participants may also enjoy using the chatbot and sharing their experiences of using the chatbot. Participants will also receive a shopping voucher for taking part in each phase of the study.
There is the potential that the interviews, focus groups, workshops, and questionnaires included in this research may include content that could be distressing to participants. To minimise the risk of distress, participants will be informed that they do not have to answer any questions they do not feel comfortable answering and that they have the right to withdraw from the study at any point.
Where is the study run from?
Sheffield Children's NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
December 2020 to March 2024
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Professor Paul Dimitri, paul.dimitri@nhs.net
Jacob Branchflower, jacob.branchflower@nihr.ac.uk
Contact information
Scientific
The Academic Unit of Child Health
Damer St. Building
Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
S10 2TH
United Kingdom
| Phone | +44 (0)114 271 7354 |
|---|---|
| paul.dimitri@nhs.net |
Scientific
Project Manager
Clarkson St
Broomhall
Sheffield
S10 2TH
United Kingdom
 ORCID ID |
0000-0002-8099-5663 |
|---|---|
| jacob.branchflower@nihr.ac.uk |
Study information
| Study design | Interventional non randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The development of a chatbot to support successful transition to adult care of young people with type 1 diabetes mellitus |
| Study objectives | Our team of doctors, nurses, young people (YP), parents/guardians, researchers, and technologists plan to create a new way of helping YP with type 1 diabetes to become confident at self-managing their diabetes when they move (‘transition’) from children’s to adult healthcare. To do this, we will develop a YP friendly diabetes chatbot (software for online chat), with avatars and linked videos. It is hypothesised that regularly using the chatbot for six weeks will improve anxiety levels, depression levels, and health-related quality of life. |
| Ethics approval(s) | Approved 17/06/2021, East of Scotland Research Ethics Service (Ninewells Hospital & Medical School, Tayside Medical Science Centre (TASC), Residency Block, Level 3, George Pirie Way, Dundee, DD1 9SY, UK; +44 (0)1382 383871; tay.eosres@nhs.scot), ref: LR/21/ES/0056 |
| Health condition(s) or problem(s) studied | Type 1 diabetes |
| Intervention | This registration focuses on Work Package 7, however all the WPs are described for background information. We will deliver our four objectives across one pre-development phase and eight work packages: PRE-DEVELOPMENT PHASE (months 1-4) The pre-development phase includes the project scoping review, applying for relevant approvals, and study set up. WORK PACKAGE 1: CO-DESIGN 1 (months 4-6) During work package 1, we will conduct the initial focus groups that are required to develop the first iteration of the chatbot and supporting materials. This work package therefore includes conducting four focus groups with YP with T1DM who are cared for by one of four NHS sites. We will also conduct informal interviews and one half day workshop with YP and their families who are more socially and digitally excluded. The interviews and workshop will focus on the possible barriers and enablers in terms of life context (e.g., disabilities, language, culture, poverty, mental health), digital skills and confidence, as well as accessibility of digital resources, communication between health care professionals and YP/parents/carers, and current services. WORK PACKAGE 2: REPORT (months 7-9) A report combining the scoping review and findings from work package 1 will inform the development of the first version of the chatbot in work packages 3 and 4. WORK PACKAGE 3 & 4: PRODUCT DEVELOPMENT 1 (months 9-12) The first version of the chatbot and supporting materials will be produced. The chatbot will be curated (relevant information and topics selected and organised) by the research team. IBM will also deliver training to the research team so they can independently manage the chatbot in the future. During work package 4, we will reconvene the half day workshop with socially and digitally excluded YP/families from work package 1. We will draw on existing examples including NHS-WDP (Widening Digital Participation) which will include digital skills development, access to the internet and Wi-Fi, community connections, videos, text reminders, reward and recognition, peer support, and coaching. This workshop will also focus on what enhancements might help to lift the barriers to YP benefitting from the chatbot. WORK PACKAGE 5: CO-DESIGN 2 (months 13-14) During work package 5, we will reconvene the four focus groups from work package 1. These focus groups will focus on assessing the usability, functionality, and content of the chatbot and supporting materials. We will also conduct four focus groups with health care professionals (6-8 professionals per site). These focus groups will focus on assessing the chatbot from a professional point of view. WORK PACKAGE 6: PRODUCT DEVELOPMENT 2 (months 15-16) In this work package, IBM, DigiBete, and the subcontractors will make the changes to the chatbot and supporting materials as determined by work packages 4 and 5. WORK PACKAGE 7: FEASIBILITY STUDY (months 17-27) We will conduct a short feasibility trial to explore the accessibility, usability, and acceptability of the chatbot for YP with T1DM. We will invite 32-40 YP (8-10 at each NHS site) to take part in the feasibility study. At baseline (T0), we will collect background data for YP (age, sex, postal code, ethnicity). At baseline (T0), 2 weeks (T1), and 6 weeks (T2), YP will use their digital device to complete a set of standardised measures using a secure web-application. At the end of the 6-week trial, we will conduct individual interviews with YP as well as focus groups with health professionals and parents/guardians to obtain rich qualitative data in addition to the questionnaire data: Interviews All YP who completed the feasibility trial will be asked to take part in a 30 - 60 minute interview. YP will be able to bring a parent or guardian to this interview if they would like to. Health care professional focus groups Health care professional focus groups will be conducted to determine views on administering, teaching, and supporting the platform as well as to assess the impact they perceive it had on clinical management. There will be four health professional focus groups, one at each site. Parent/guardian focus groups Parent/guardian focus groups will also take place to explore their views on the strengths and limitations of a chatbot for their child becoming more autonomous in self-management. The parent focus groups at each site will comprise the parents of the YP participating in the feasibility trial with a maximum of 10 per group. WORK PACKAGE 8: DISSEMINATION (months 28-30) The study team will work closely with the Expert User Group to maximise the study outputs: 1. Work with YP to disseminate findings of this work to peers and families, accounting for socially and digitally excluded groups, in an innovative and engaging way (work package 7 focus groups and interviews will address this); 2. A report as per standard NIHR contract to the relevant authority; 3. Summary of study findings on NIHR Children and Young People MedTech Co-operative and DigiBete websites; 4. Study published in an open-access, high-quality, peer-reviewed scientific journal; and 5. Conference presentations. |
| Intervention type | Behavioural |
| Primary outcome measure | At baseline, 2 weeks and 6 weeks: 1. Usability measured using The System Usability Scale (SUS) 2. Acceptability measured using The Mobile App Rating Scale (MARS) |
| Secondary outcome measures | At baseline, 2 weeks and 6 weeks: 1. Anxiety and Depression measured using The Hospital Anxiety and Depression Scale (HADS) 2. Health-Related Quality of Life measured using The Short-Form 36 (SF-36) 3. Young people’s, parent/carers’, and health professionals’ experiences and perspectives will be measured using qualitative focus groups and interviews at the end of the study. We will use Framework to analyse qualitative data; Framework is a systematic method for handling large qualitative data sets by iterating between: collecting data, identifying themes, coding/labelling data, identifying categories, and possible interpretations. Constant comparison of data, supplemented by regular project management group discussions, will open up meaning. |
| Overall study start date | 01/12/2020 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 11 Years |
| Upper age limit | 25 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 249; UK Sample Size: 249 |
| Total final enrolment | 79 |
| Key inclusion criteria | 1. Aged 11 - 25 years 2. Diagnosed with type 1 diabetes mellitus (T1DM) 3. Cared for by the Diabetes Clinical Teams at one of four NHS sites (Sheffield Children's Hospital, Leeds Children's Hospital, Royal Liverpool University Hospital, University Hospitals Birmingham) 4. Fluent in spoken English 5. Familiar with using a PC, smartphone, or tablet (DigiBete operates on 96% of mobile phones supporting apps up to Android 7 and IOS from iPhone 6. (For YP who do not have access to any of these devices we will provide them with the equipment to support their involvement with the trial.) 6. If in paediatric diabetes services: expected to transfer to adult NHS diabetes service 7. If in adult diabetes services: transferred from a paediatric NHS diabetes services 8. The exact inclusion criteria for digitally and socially excluded YP will be determined by the scoping review currently being undertaken by mHabitat |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 31/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Sheffield
S10 2TH
United Kingdom
Leeds
LS9 7TF
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Edgbaston
Birmingham
B15 2GW
United Kingdom
Sponsor information
Hospital/treatment centre
Western Bank
Sheffield
S10 2TH
England
United Kingdom
| Phone | +44 (0)1142717000 |
|---|---|
| gillian.gatenby@nhs.net | |
| Website | https://www.sheffieldchildrens.nhs.uk/ |
"ROR" |
https://ror.org/02md8hv62 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The study team will work closely with the expert user group to maximise the study outputs: • Work with young people to disseminate findings of this work to peers and families, accounting for socially/digitally excluded groups, in an innovative and engaging way; • A report as per standard NIHR contract to the relevant authority; • Summary of study findings on NIHR CYP MedTech and DigiBete websites; • Study published in an open-access, high-quality, peer-reviewed scientific journal within one year of the overall trial end date; and • Conference presentations. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Preprint results | 17/04/2025 | 01/05/2025 | No | No |
Editorial Notes
01/05/2025: Publication reference added.
20/05/2024: The intention to publish date was changed from 01/05/2024 to 01/03/2025.
27/12/2023: The final enrolment number has been added.
18/12/2023: The overall study end date was changed from 31/12/2023 to 31/03/2024.
08/03/2023: Contact details updated.
14/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 28/02/2023 to 31/10/2023.
2. The overall trial end date was changed from 31/05/2023 to 31/12/2023.
11/03/2022: A study contact has been added and the plain English summary has been updated accordingly.
02/08/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
