Type 1 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
The purpose of the study is testing the feasibility of the LADDER programme, the research design and the study outcomes. The study has been designed to evaluate both components of the LADDER programme
we will use a preference model in Study-A
and a waiting list design in Study-B.
Study A:
Participants (n=26) will be exposed to the LADDER sessions or an active control of four standard diabetes appointments in their usual diabetes clinic.
and those that decline randomisation will then be given the option of a preference for one allocation or the other (the preference option will only be revealed if the participant declines randomisatio
expectations and practical questions
and diabetes in everyday life. The sessions involve two visual conversational tools developed in the co-design project focussing on:
1. Diabetes in everyday life (work and relationships)
2. Diabetes
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study A: 1. Have been diagnosed with type 1 diabetes within the last month Study B: 1. Have been diagnosed with T1D >3 months and =12 months Studies A & B: 1. Aged =20 years (giving a higher likelihood of a participant living independently with responsibility for their own diabetes self-management) 2. Capacity to consent
Exclusion criteria
Exclusion criteria: 1. Severe physical/mental illness 2. Pregnancy (a pregnancy with type 1 diabetes involves intensive intervention to regulate glucose levels with weekly care in diabetes pregnancy clinics for monitoring) 3. Acute unstable retinopathy 4. Significant learning difficulties 5. Planned or current attendance at other structured education programmes 6. Unable to speak or understand English 7. Planned attendance in other structured education programmes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Following current MRC guidance for feasibility studies we have not identified an individual primary outcome for this study, as the interventions are modelled to multiple outcomes. The following measures will be used: Study A: 1. Acceptance is measured using the Illness Identity Questionnaire (IIQ) at 2, 4, and 6 months 2. Illness perception is measured using the Brief Illness Perception Questionnaire (BIPQ) at baseline, 2, 4, and 6 months 3. Depression and low mood are measured using the WHO-5 Wellbeing Index at baseline, 2, 4, and 6 months 4. Diabetes distress is measured using the Problem Areas in Diabetes Scale (PAID) at 2, 4, and 6 months 5. Diabetes resilience is measured using the Diabetes Empowerment Scale - Short Form (DES-SF) at 2, 4, and 6 months 6. Interactions with health care professionals is measured using the Health Care Climate Questionnaire (HCCQ) at baseline, 2, 4, and 6 months 7. Perceived Stress is measured using the Perceived Stress Scale (PSS) at baseline, 2, 4, and 6 months 8. Impact of diabetes on everyday life is measured using the DAWN-2 questionnaire at baseline, 2, 4, and 6 months 9. Social support is measured using the Experiences in Close Relationships Scale - Short Form (ECR-SF) at baseline and 6 months 10. Engagement with diabetes care is measured using attendance at screening and diabetes appointments at end of the study 11. Glycaemic control is measured using HbA1c at baseline, 2, 4, and 6 months Study B: 1. Acceptance is measured using the Illness Identity Questionnaire (IIQ) at baseline, 3, 5, and 9 months 2. Illness perception is measured using the Brief Illness Perception Questionnaire (BIPQ) at baseline, 3, 5, and 9 months 3. Depression and low mood are measured using the Patient Health Questionnaire-9/WHO-5 Wellbeing Index at baseline, 3, 5, and 9 months 4. Diabetes distress is measured using the Problem Areas in Diabetes Scale (PAID) at baseline, 3, 5, and 9 months 5. Diabetes resilience is measured using the Diabetes Empow | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactRhawann El Hakim
Outcome results
None listed