Type 2 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a single-centre study comprising an observational study (WP1) and a qualitative interview study (WP2).
WP1: Observational Study
We will invite individuals with EOT2D to register on and use a
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Work Package 1: Observational Study 1. Diagnosis of T2DM before the age of 40 years (inclusive) 2. Aged >=18 and <=45 years at time of recruitment (inclusive) 3. Access to information technology to access EOT2D MyDESMOND 4. Capacity and willingness to provide informed consent to participate in the study 5. Sufficient written and verbal English communication skills to understand the Participant Information Sheet (PIS) and Informed Consent Form (ICF) Work Package 2: Qualitative Interview Study Participants taking part in the observational study will be invited to a one-off interview. Inclusion criteria as above; access to information technology required to participate in remote interviews. Inclusion criteria for stakeholders: 1. An understanding of the care pathway for people with EOT2D 2. Those involved in the delivery or commissioning of care for people with EOT2D 3. Individuals involved in the provision of MyDESMOND or other digital diabetes education within an NHS setting 4. Sufficient written and verbal English communication skills to understand the PIS and ICF 5. Capacity and willingness to provide informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Work Package 1: Observational Study 1. Diagnosed with other forms of diabetes (e.g. type 1 diabetes, gestational diabetes) 2. Has been an active MyDESMOND user in the last 6 months 3. No access to an electronic device to support the use of EOT2D MyDESMOND 4. Unwilling or unable to give informed consent to participate in the study Work Package 2: Qualitative Interview Study 1. Unwilling or unable to give informed consent to participate in the study 2. If required to participate in remote interviews, no access to information technology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Retention, defined as the duration between the day a user registered for EOT2D MyDESMOND and the last day they accessed it during the 12-month study period. 2. Engagement, defined as the total number of logins per user during the 12 months following registration. Other user engagement outcomes per user during the 12 months include: 2.1. Total time spent using the programme 2.2. Estimated time spent per log-in (total time spent in the programme divided by total number of logins) 2.3. Logins per week (total number of log-ins divided by number of weeks spent using the programme) Other outcomes include: 1. Conversion rates, defined as the number of individuals who are sent an EOT2D MyDESMOND registration code who go on to register 2. Self-reported outcomes, as detailed below, which are all measured at baseline, 3, 6 and 12 months. Please note, self-reported data is not mandatory for participants to provide. 2.1. HbA1c (mmol or %) 2.2. Anthropometric variables (body weight kg, waist circumference cm) 2.3. Diabetes self-efficacy is measured using the Diabetes Management Self-Efficacy Scale (DMSES) 2.4. Diabetes distress is measured using the Problems Areas In Diabetes Scale (PAID-5) 2.5. Self-compassion is measured using the Self-Compassion Scale (SSC) 2.6. Diabetes stigma is measured using the Type 2 Diabetes Stigma Assessment Scale (DSAS-2) 2.7. Illness perceptions measured using the Brief Illness Perception Questionnaire (B-IPQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome for this study is a ‘fit-for-purpose’ implementation strategy for the EOT2D digital self-management programme developed with input from people with EOT2D, PPI and stakeholders (including healthcare professionals, commissioners, charity leads). | — |
Countries
England, United Kingdom
Outcome results
None listed