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NCT Number: NCT06844006

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

Location status: Recruiting

Location contact

M.D., Ph.D., FESC, FEACVI, FHFA

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Nudging

Combination Product

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.

Primary outcomes

  1. HF related hospitalization

    Time frame: From enrollment to the end of the design (15 months).

    The frequency of HF related hospitalization and duration of the hospitalization.

  2. All cause death

    Time frame: All cause death rate during the 15 month duration of the study.

Sponsors and collaborators

Lead sponsor

Medisch Spectrum Twente

Other

Collaborators

  • Canisius-Wilhelmina Hospital
  • Catharina Ziekenhuis Eindhoven
  • Maasstad Hospital, Rotterdam
  • Martini Hospital Groningen
  • Onze Lieve Vrouwe Gasthuis
  • St. Antonius Hospital

Registry information

Official study title

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

Acronym: ADMINISTER II

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 25, 2025
Registry last updated
Mar 7, 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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