Chatbot for young people with type 1 diabetes mellitus

Not Applicable

Completed

Conditions: Type 1 diabetes
Nutritional, Metabolic, Endocrine
Type 1 diabetes mellitus

Registration Number: ISRCTN15525627

Lead Sponsor: Sheffield Children's NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 79

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

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At baseline, 2 weeks and 6 weeks:<br>1. Usability measured using The System Usability Scale (SUS) <br>2. Acceptability measured using The Mobile App Rating Scale (MARS)

Secondary Outcome Measures

Name	Time	Method
At baseline, 2 weeks and 6 weeks:<br>1. Anxiety and Depression measured using The Hospital Anxiety and Depression Scale (HADS)<br>2. Health-Related Quality of Life measured using The Short-Form 36 (SF-36)<br><br>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.