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Completed

NCT Number: NCT06300086

Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease

Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines.

This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, Capital Region, 2900, Denmark

About this study

The study is a prospective, 2x2 factorial, registry-based, randomized, open-label implementation trial. The study population will consist of Danish adults diagnosed with CKD. Participants will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10).

The primary objective of this study is to investigate the effects of electronically sent nudging letters delivered directly to (1) patients with CKD and, separately, (2) electronically sent nudge letters delivered to GPs of the included CKD patients on the primary outcome of use of GDMT defined as at least one prescription of RASi or SGLT2i 6 months after intervention delivery in patients with CKD.

Patients with CKD will be randomized (1:1) to either a control arm (no digital nudge letters sent to the patient) or an intervention arm (a digital nudge letter). GPs of the enrolled patients with CKD will be randomized (1:1) to a control arm (no digital nudge letters sent to the GP) or an intervention arm (a digital nudge letter). The letters will inform the recipients about the importance of GDMT in CKD and that updated Danish guidelines for treating CKD are available. The letter to the GPs will also include the definition of CKD and a summary of the guidelines.

The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries except for information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms.

This study will coincide with the release of the updated clinical guidelines on the treatment of CKD by the Danish Society of Nephrology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age +18 years
  • Diagnosis of CKD defined as at least one hospital encounter with the following ICD-10 codes in the primary diagnostic positions within ≤ 5 years: N18- N19, I12, E102, E112, E132, E142.

Exclusion criteria

For patient-level intervention comparisons:

  • Exemption from the official, mandatory Danish electronic mailbox system.

For general practice-level intervention comparisons:

  • Individuals on a patient list of general practice clinics run by Danish administrative Regions.
  • Individuals not on a patient list of a general practice.

Treatment and study plan

Electronically delivered nudging letters to patients with CKD

Behavioral

Patients in the active arm will receive a digital nudge letter as part of the study. The nudge letter will be delivered at baseline. Letters will be delivered through the official, mandatory Danish electronic letter system.

The control arm will consist of patients with CKD randomized to not receive digital nudge letters (usual care).

Other names: Patient letters

Electronically delivered nudging letter to associated GPs of patients with CKD

Behavioral

The associated GPs of the patients in the active arm will receive one digital nudge letter as part of the study. The nudge letter will be delivered at baseline. The letters will be delivered through the official, mandatory Danish electronic letter system.

The control arm will consist of patients with CKD whose associated GP was randomized to not receive a digital nudge letter (usual care).

Other names: GP letter

Primary outcomes

  1. Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors

    Time frame: within 6 months

Secondary outcomes

  1. Number of participants with any prescription of renin-angiotensin system inhibition

    Time frame: within 6 months

  2. Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors

    Time frame: within 6 months

  3. Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors

    Time frame: within 6 months

  4. Number of participants with a new prescription of renin-angiotensin system inhibition

    Time frame: within 6 months

  5. Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors

    Time frame: within 6 months

  6. Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors

    Time frame: within 6 months

  7. Time from intervention delivery to a new prescription of renin-angiotensin system inhibition

    Time frame: within 6 months

  8. Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors

    Time frame: within 6 months

Other outcomes

  1. Number of participants with an increase in baseline daily RASi dosage

    Time frame: within 6 months

  2. Number of participants with any prescription of mineralocorticoid receptor antagonists

    Time frame: within 6 months

  3. Number of participants with any prescription of non-steroid mineralocorticoid receptor antagonists

    Time frame: within 6 months

  4. Number of participants with any prescription of cholesterol-lowering medication

    Time frame: within 6 months

  5. Number of participants with any prescription of glucagon-like peptide-1 analogue

    Time frame: within 6 months

  6. Number of participants with any prescription of antidiabetic medication besides SGLT2i

    Time frame: within 6 months

  7. Number of participants with any prescription of antidiabetic medication

    Time frame: within 6 months

  8. Number of participants with any prescription of antihypertensive medication besides renin-angiotensin system inhibition

    Time frame: within 6 months

  9. Number of participants with any prescription of antihypertensive medication

    Time frame: within 6 months

  10. Number of participants with a new prescription of mineralocorticoid receptor antagonists

    Time frame: within 6 months

  11. Number of participants with a new prescription of non-steroid mineralocorticoid receptor antagonists

    Time frame: within 6 months

  12. Number of participants with a new prescription of cholesterol-lowering medication

    Time frame: within 6 months

  13. Number of participants with a new prescription of glucagon-like peptide-1 analogue

    Time frame: within 6 months

  14. Number of participants with a new prescription of antidiabetic medication besides sodium-glucose cotransporter 2 inhibitors

    Time frame: within 6 months

  15. Number of participants with a new prescription of antidiabetic medication

    Time frame: within 6 months

  16. Number of participants with a new prescription of antihypertensive medication besides renin-angiotensin system inhibition

    Time frame: within 6 months

  17. Number of participants with a new prescription of antihypertensive medication

    Time frame: within 6 months

  18. Change in number of antihypertensive medications

    Time frame: within 6 months

  19. Number of participants referred to nephrology outpatient clinics

    Time frame: within 6 months

  20. Number of participants with an assessment of urine albumine to creatine ratio

    Time frame: within 6 months

  21. Number of participants with an assessment of plasma-creatinine.

    Time frame: within 6 months

  22. Number of participants with an assessment of estimated glomerular filtration rate by creatinine

    Time frame: within 6 months

  23. Number of participants with an assessment of hemoglobin A1c

    Time frame: within 6 months

  24. Number of participants with an assessment of lipids

    Time frame: within 6 months

  25. Number of participants recipient of influenza vaccination

    Time frame: within 6 months

  26. Number of participants recipient of COVID-19 vaccination

    Time frame: within 6 months

  27. Total number of visits to general practitioners

    Time frame: within 6 months

  28. Time to first phone contact to a general practice

    Time frame: within 6 months

  29. Time to first visit with a general practitioner

    Time frame: within 6 months

  30. Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors

    Time frame: Within 1, 2, 5 and 10 years

  31. Number of participants with any prescription of renin-angiotensin system inhibition

    Time frame: Within 1, 2, 5 and 10 years

  32. Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors

    Time frame: Within 1, 2, 5 and 10 years

  33. Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors

    Time frame: Within 1, 2, 5 and 10 years

  34. Number of participants with a new prescription of renin-angiotensin system inhibition

    Time frame: Within 1, 2, 5 and 10 years

  35. Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors

    Time frame: Within 1, 2, 5 and 10 years

  36. Time from intervention delivery to prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors

    Time frame: Within 1, 2, 5 and 10 years

  37. Time from randomization to prescription of renin-angiotensin system inhibition

    Time frame: Within 1, 2, 5 and 10 years

  38. Time from randomization to prescription of sodium-glucose cotransporter 2 inhibitors

    Time frame: Within 1, 2, 5 and 10 years

  39. Number of participants who have discontinued renin-angiotensin system inhibition treatment.

    Time frame: Within 1, 2, 5 and 10 years

  40. Number of participants who have discontinued sodium-glucose cotransporter 2 inhibition treatment.

    Time frame: Within 1, 2, 5 and 10 years

  41. Rate of change in estimated glomerular filtration rate

    Time frame: Within 1, 2, 5 and 10 years

  42. Rate of change in urine albumine to creatinine ratio

    Time frame: Within 1, 2, 5 and 10 years

  43. Number of participants with any hospitalization

    Time frame: Within 1, 2, 5 and 10 years

  44. Total number of all-cause hospitalizations

    Time frame: Within 1, 2, 5 and 10 years

  45. All-cause mortality

    Time frame: Within 1, 2, 5 and 10 years

  46. Number of participants with kidney failure defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence and kidney transplantation

    Time frame: Within 1, 2, 5 and 10 years

  47. Number of participants with kidney failure (alternative definition #1) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation and renal death

    Time frame: Within 1, 2, 5 and 10 years

  48. Number of participants with kidney failure (alternative definition #2) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation, renal death, and cardiovascular death.

    Time frame: Within 1, 2, 5 and 10 years

  49. Number of participants with acute dialysis

    Time frame: Within 1, 2, 5 and 10 years

  50. Number of participants with acute kidney insufficiency

    Time frame: Within 1, 2, 5 and 10 years

  51. Number of participants with incident heart failure, heart failure hospitalization, or cardiovascular death

    Time frame: Within 1, 2, 5 and 10 years

  52. Number of participants with major adverse cardiovascular events defined as a composite of myocardial infarction, stroke, and cardiovascular death.

    Time frame: Within 1, 2, 5 and 10 years

  53. Number of participants with major adverse cardiovascular events (alternative definition) defined as a composite of myocardial infarction, revascularization, stroke, and cardiovascular death.

    Time frame: Within 1, 2, 5 and 10 years

  54. Number of participants with individual components of the renal/cardiovascular composite outcomes

    Time frame: Within 1, 2, 5 and 10 years

Sponsors and collaborators

Lead sponsor

Tor Biering-Sørensen

Other

Registry information

Acronym: NUDGE-CKD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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