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Chronic Kidney DiseasesNUDGE-CKDNCT06300086

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

A study testing Electronically delivered nudging letters to patients with CKD and Electronically delivered nudging letter to associated GPs of patients with CKD in people with Chronic Kidney Diseases and Behavior and Behavior Mechanisms, run by Tor Biering-Sørensen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Electronically delivered nudging letters to patients with CKD and Electronically delivered nudging letter to associated GPs of patients with CKD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28,388 participants
Where
1 siteDenmark
Study dates
19 Aug 2024to 19 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • For patient-level intervention comparisons:
  • 1) 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

    Hellerup, Capital Region, 2900

Other trials in Denmark

About this study

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.

Read the detailed description

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.

Being tested
Electronically delivered nudging letters to patients with CKD, Electronically delivered nudging letter to associated GPs of patients with CKD
Keywords
Chronic Kidney Disease, Nudging, Behavioral Science, Guideline-directed medical therapy
Medical subject headings
Renal Insufficiency, Chronic, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronically delivered nudging letters to patients with CKDBehavioural

    Also called Patient letters

    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).

  • Electronically delivered nudging letter to associated GPs of patients with CKDBehavioural

    Also called GP letter

    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).

Study groups in NCT06300086
Study groupRoleWhat they receive
Patient letters + no GP letter.ExperimentalPatients with CKD will receive digital nudge letters, but their associated GPs will not receive a digital nudge letter. The letters will inform patients with CKD of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available.
Receives: Behavioral: Electronically delivered nudging letters to patients with CKD
Patient letters + GP letter.ExperimentalPatients with CKD and their associated GPs will receive digital nudge letters. The letters will inform the recipients of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. The letter to the GPs will also include the definition of CKD and a summary of the guidelines.
Receives: Behavioral: Electronically delivered nudging letters to patients with CKD; Behavioral: Electronically delivered nudging letter to associated GPs of patients with CKD
No patient letters + GP letterExperimentalPatients with CKD will not receive digital nudge letters, but their associated GPs will receive a digital nudge letter. The letter will inform the GPs of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. The letter will also include the definition of CKD and a summary of the guidelines.
Receives: Behavioral: Electronically delivered nudging letter to associated GPs of patients with CKD
No patient letters + no GP letterNo interventionNeither patients with CKD nor their associated GPs will receive digital nudge letters.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: within 6 months

Secondary outcomes (8)
  1. Number of participants with any prescription of renin-angiotensin system inhibition

    Measured: within 6 months

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

    Measured: within 6 months

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

    Measured: within 6 months

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

    Measured: within 6 months

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

    Measured: within 6 months

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

    Measured: within 6 months

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

    Measured: within 6 months

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

    Measured: within 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2024
  2. Study start19 Aug 2024
  3. Primary completion19 Feb 2025
  4. Study completion19 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Model description
2x2 factorial design
Masking
None (open label)
Enrolment
28,388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06300086
Sponsor's protocol ID
NUDGE-CKD
Acronym
NUDGE-CKD
Status last verified
Sep 2025
First submitted
16 Feb 2024
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.

Publications

  • Skaarup KG, Johansen ND, Brandi L, Lindhardt MK, Bech JN, Svensson M, Kristensen T, Thuesen AD, Knudsen MG, Kampmann JD, Hornum M, Orts B, Modin D, Lassen MCH, Janstrup KH, Claggett BL, Vaduganathan M, Bhatt AS, Van Spall HGC, Jensen JUS, Zannad F, Solomon SD, Moller A, Borg R, Birn H, Hansen D, Biering-Sorensen T. A Nationwide Factorial Randomized Trial of Electronic Nudges to Patients With Chronic Kidney Disease and Their General Practices for Increasing Guideline-Directed Medical Therapy: The NUDGE-CKD Trial. Circulation. 2025 Aug 12;152(6):369-383. doi: 10.1161/CIRCULATIONAHA.125.075403. Epub 2025 Jun 7.

    PubMed 40481660
  • Skaarup KG, Johansen ND, Brandi L, Lindhardt MK, Bech JN, Svensson M, Kristensen T, Thuesen AD, Knudsen MG, Kampmann JD, Hornum M, Orts B, Modin D, Lassen MCH, Janstrup KH, Claggett BL, Vaduganathan M, Bhatt AS, Van Spall H, Jensen JUS, Zannad F, Solomon SD, Moller A, Borg R, Birn H, Hansen D, Biering-Sorensen T. Rationale and design of NUDGE-CKD: A nationwide randomized factorial trial of electronic nudges for increasing guideline-directed medical therapy in chronic kidney disease. Am Heart J. 2025 Sep;287:61-78. doi: 10.1016/j.ahj.2025.03.015. Epub 2025 Mar 31.

    PubMed 40174694

Questions about this trial

What is this clinical trial studying?

A study testing Electronically delivered nudging letters to patients with CKD and Electronically delivered nudging letter to associated GPs of patients with CKD in people with Chronic Kidney Diseases and Behavior and Behavior Mechanisms, run by Tor Biering-Sørensen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors (time frame: within 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06300086, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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