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Investigating the Impact of Nudging Cardiologists to Prescribe Guideline-directed Medical Therapy in Heart Failure Patients

Assessment of Digital Care on Clinical Impact and Efficiency Using a Stepped Wedge Cluster RCT in Heart Failure Patients: the ADMINISTER II Trial

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06844006
Acronym
ADMINISTER II
Enrollment
1320
Registered
2025-02-25
Start date
2024-06-13
Completion date
2028-08-31
Last updated
2026-08-10

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

Conditions

Heart Failure

Keywords

Digitial Care, Home monitoring, Heart Failure, Nudging

Brief summary

This study investigates the impact of a nudge-based intervention on improving guideline directed medical therapy (GDMT) prescription among cardiologists. Using a stepped wedge randomized controlled trial design, we assess whether digital decision support-leveraging home monitoring and clinical data-enhances adherence to guideline-recommended medication titration. The primary outcomes include HF related hospitalization rates and all cause mortality.

Interventions

COMBINATION_PRODUCTNudging

Clinicians will be nudged with a prompt, based on remote monitoring data, current medication data, contraindications, in the electronic patient dossier whether further optimization to guideline directed medical therapy (GDMT) is possible.

Sponsors

Medisch Spectrum Twente
Lead SponsorOTHER
Onze Lieve Vrouwe Gasthuis
CollaboratorOTHER
St. Antonius Hospital
CollaboratorOTHER
Catharina Ziekenhuis Eindhoven
CollaboratorOTHER
Maasstad Hospital, Rotterdam
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Stepped Wedge Randomized Controlled Trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All heart failure diagnoses * \>18 years

Exclusion criteria

* Not understanding the Dutch Language. * Allergies that make uptitration impossible. * Admission to hospice or palliative care. * Severe psychological disorders.

Design outcomes

Primary

MeasureTime frameDescription
HF related hospitalizationFrom enrollment to the end of the design (15 months).The frequency of HF related hospitalization and duration of the hospitalization.
All cause deathAll cause death rate during the 15 month duration of the study.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026