Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Randomisation is at practice-level stratified by CCG and will be performed prior to baseline in a 1:1 fashion to either the immediate group or the wait-list group.
The immediate group will provide u
very good evidence about these programmes already exists. The trialists will be working with education providers, CCG staff (local NHS providers of primary healthcare) and 66 GP practices to improve t
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients – data extraction and mail-out: All patients registered at a participating practice and meeting the following eligibility criteria will have pseudonymised one line per patient data extracted, and will be mailed an invitation pack which includes an invitation letter, PIS and questionnaire booklet. The questionnaire booklet contains a self-report questionnaire and a consent form which gives patients the option to have their questionnaire responses linked to their attendance data in their practice and Provider records. Patient inclusion criteria: 1. Registered at a participating practice 2. Aged =18 years old 3. Coded in their primary care medical record as diagnosed with T2DM before or during the study period (to be reassessed at each data extraction point) 4. Willing and able to provide informed consent (Applicable to optional consent form and questionnaire booklet only) 5. Able to understand written English to a level sufficient to enable an understanding of the research and their participation within it (applicable to optional consent form and questionnaire booklet only) Patients – ethnographic sub-study: Patients who express an interest to participate in the ethnographic sub-study and meet the following eligibility criteria will be eligible for the ethnographic sub-study Patient inclusion criteria: 1. Meet all of the above patient eligibility criteria 2. Is able to attend the practice unaided or with a carer or support (applicable to observations of consultations only)
Exclusion criteria
Exclusion criteria: Practice exclusion criteria: 1. Unable to make contact with practice manager or equivalent Patient exclusion criteria - data extraction and mail-out: 1. Coded in their primary care medical records as having a terminal illness 2. Coded in their primary care medical records as housebound or in residential care 3. A dissent code in their primary care medical records for researcher to access clinical data Patient exclusion criteria - ethnographic sub-study: 1. Unable to understand spoken English to a level sufficient to enable an understanding of the research and their participation within it Stakeholder exclusion criteria: 1. Unable to understand written and spoken English to a level sufficient to enable an understanding of the research and their participation within it
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-level HbA1c compared between the control (months 0-3 in immediate group and months 0-12 in wait-list group) and intervention (months 3-21 in immediate group and 12-21 in wait-list group) conditions in the RCT | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at month 0 (baseline), Month 0-9, Month 9-18 and Month 18-30: 1. Body mass index, if not available in GP system calculated from weight and height 2. Weight and height, as per method recorded in GP system 3. Total, LDL and HDL cholesterol, as per method recorded in GP system 4. Systolic and diastolic blood pressure, as per method recorded in GP system 5. Glucose, blood pressure and lipid lowering medications, as per method recorded in GP system 6. Smoking status, as per method recorded in GP system 7. Hospital admissions, as per method recorded in GP system – using appropriate Read-code to identify 8. QRisk2 score (a measure of cardiovascular risk), as per method recorded in GP system Secondary process outcomes: 1. Whether or not the patient was referred to and attended, measured using Read-code from GP system at Month 0 (baseline), Month 0-9, Month 9-18 and Month 18-30; self-reported by patient in questionnaire at beginning of study; on receipt of self-report from patients education providers will be asked (will vary per site) 2. Percentage of eligible individuals referred to education, measured using Read-code from GP system at Month 0 (baseline), Month 0-9, Month 9-18 and Month 18-30 3. Percentage of eligible individuals who attended education, measured using Read-code from GP system at Month 0 (baseline), Month 0-9, Month 9-18 and Month 18-30 4. Percentage of eligible individuals who declined education, measured using Read-code from GP system at Month 0 (baseline), Month 0-9, Month 9-18 and Month 18-30 5. Number, timing and venue of available education sessions, measured using education provider questionnaire monthly 6. Number of trained educators, measured using education provider questionnaire monthly Secondary psychosocial and process outcomes: 1. Where the patient has previously received diabetes information from, measured using self-report questionnaire at single time-point during month 0-9 2. Patient Activation Measure, measured using validated P | — |
Countries
England, United Kingdom
Outcome results
None listed