Digital multi-component intervention to improve the care of older people living with diabetes and chronic kidney disease

Digital multi-component intervention to IMPROVE the care of older people living with Diabetes and Chronic Kidney Disease (IMPROVE DKD): A type 2 hybrid effectiveness-implementation cluster randomised trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35585192

Enrollment

1500

Registered

2025-11-03

Start date

2025-11-15

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic kidney disease (DKD) Nutritional, Metabolic, Endocrine

Interventions

This is a type II hybrid effectiveness-implementation cluster randomised trial. The trial includes a study within a trial (SWAT) to assess the value of modelling trial outcomes using process of care d

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Cluster General practices (GPs) will be eligible to take part in the research if they are: 1. Using Optum software for patient care records 2. Signed up and reporting data to CPRD Cluster patients 1. Type 2 diabetes mellitus 2. Aged 18-80 years (although a subset of these patients =60 will inform the main analysis data-set ) 3. eGFR 30-59 ml/min/1.73m2 (CKD stage 3)

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes mellitus, known primary renal disease (e.g., glomerulonephritis, vasculitis, adult polycystic kidney disease) 2. On immunosuppression therapy 3. On dialysis or received a kidney transplantation 4. Active malignancy 5. On end-of-life care/pathway 6. Dementia 7. Opted out of contributing data to CPRD

Design outcomes

Primary

Measure	Time frame
1. Change in eGFR (ml/min/1.73m2) calculated from the serum creatinine (SCr) value using the CKD-Epi Creatinine Equation using data obtained via routine data collection for a period of 2 years post-randomisation 2. GP adherence to all five Joint ABCD-UKKA guideline recommendations will be measured using anonymised routine data, initially recorded in the EHR, which will include documentation and/or recorded action taken (e.g. measurement and/or prescription) at 12 months post-randomisation	—

Measure

Time frame

1. Change in eGFR (ml/min/1.73m2) calculated from the serum creatinine (SCr) value using the CKD-Epi Creatinine Equation using data obtained via routine data collection for a period of 2 years post-randomisation 2. GP adherence to all five Joint ABCD-UKKA guideline recommendations will be measured using anonymised routine data, initially recorded in the EHR, which will include documentation and/or recorded action taken (e.g. measurement and/or prescription) at 12 months post-randomisation

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Secondary

Measure	Time frame
The following secondary outcome measures are measured using anonymised routine data at 12 months post-randomisation: 1. A composite of eGFR decline >50%, end-stage kidney disease (ESKD) and all-cause mortality 2. Non-fatal myocardial infarction (MI), non-fatal stroke, hospitalisation for heart failure 3. Components of the implementation endpoints – BP control, glycaemic control and the use of RAASi, SGLT2I and statin	—

Measure

Time frame

The following secondary outcome measures are measured using anonymised routine data at 12 months post-randomisation: 1. A composite of eGFR decline >50%, end-stage kidney disease (ESKD) and all-cause mortality 2. Non-fatal myocardial infarction (MI), non-fatal stroke, hospitalisation for heart failure 3. Components of the implementation endpoints – BP control, glycaemic control and the use of RAASi, SGLT2I and statin

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Countries

England, United Kingdom, Wales

Contacts

Public ContactRaquel Fernandez del Rio

improvedkd@trials.bham.ac.uk+44 (0)121 414 3344

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026