Diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
This study is a mixed-methods external randomised controlled trial, collecting quantitative and qualitative data. Recruitment will be carried out from two clinical sites. Participants will be patients
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Has diabetes (according to World Health Organization [WHO] criteria) 2. Aged 18 years or over 3. Has two lower limbs (i.e. has not had major amputation of either lower limb) 4. Has a recently healed diabetic foot ulcer (if more than one, all must be healed), defined as fully epithelialised with no drainage, for a minimum of 2 weeks 5. Has the cognitive capacity to provide informed consent, to engage with the study intervention (both as digital and written handbook versions), to take part in interviews (if randomised to the intervention), and to provide follow-up data 6. Has sufficient command of English language to engage with the intervention and to provide follow-up data
Exclusion criteria
Exclusion criteria: 1. Has active Charcot Neuro-osteoarthropathy 2. Presence of active diabetic foot ulceration 3. Diagnosis of a current severe mental illness which could hinder engagement with the trial and/or intervention (e.g., psychosis) 4. Has previously been randomised to this pilot trial 5. Is currently taking part in another study which would affect the outcomes of this study (e.g. diabetic foot ulcer wound healing medicinal product trial or other behavioural intervention study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Participant’s perception of their illness measured using the Brief Illness Perception Questionnaire (B-IPQ) at baseline, 6 weeks and 12 weeks 2. Participant’s beliefs about their symptoms measured using the Cognitive and Behavioural Responses Questionnaire (CBRQ) – short version at baseline, 6 weeks and 12 weeks 3. Anxiety assessed using the Generalised Anxiety Questionnaire (GAD-7) at baseline, 6 weeks and 12 weeks 4. Depression assessed using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 6 weeks and 12 weeks 5. Participant physical activity assessed using the International Physical Activity Questionnaire - Elderly (IPAQ-E) – short form at baseline, 6 weeks and 12 weeks 6. Emotional, psychological and social well-being assessed using the Mental Health Continuum Short Form (MHC-SF) at baseline, 6 weeks and 12 weeks 7. Foot self-care behaviours assessed using the Nottingham Assessment of Functional Footcare (NAFF) at baseline, 6 weeks and 12 weeks 8. Positive feelings assessed using the Scale of Positive And Negative Experience (SPANE-P) - positive items only: Examines at Baseline, 6 weeks and 12 weeks 9. Social relationships and support assessed using the Social Provisions Scale (SPS) at baseline, 6 weeks and 12 weeks. 10. Capability including attachment, stability, achievement, enjoyment and autonomy measured using the ICEpop CAPability measure for Adults (ICECAP-A) at baseline and 12 weeks 11. Mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured using the EQ5D-5L consisting of the EQ5D descriptive system and the EQ Visual Analogue Scale (EQ VAS) at baseline and 12 weeks 12. Ulcer-free days collected from patient records at 4 months post randomisation 13. Days to re-ulceration (if re-ulceration occurs) collected from patient records at 4 months post randomisation 14. Number of ulcers collected from patient records at 4 months post randomisation 15. Days in hospital collected from patient records at 4 months post r | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed