Investigating the Impact of Nudging Cardiologists to Prescribe Class I Recommendations Foundational- and Additional Medical Therapy in Heart Failure Patients

Study acronym: ADMINISTER II
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 8 months later across 2 updates Apr 30, 2027 → Jan 9, 2028
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Record History

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  1. Start date: Jun 13, 2024 to Oct 9, 2026 Show 7 more changesShow less
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Primary completion moved earlier from Mar 30, 2028 to Jan 9, 2028
    • Study completion moved earlier from Aug 31, 2028 to Jul 9, 2028
    • Eligibility criteria expanded, about 6 words
    • Collaborators revised (4)
    • Publications: details revised at 1 of 1 entry
    • Study title expanded, about 5 words
  2. Primary completion pushed from Apr 30, 2027 to Mar 30, 2028v4 Show 4 more changesShow less
    • Trial status changed: Recruiting → Enrolling by Invitation
    • Trial sites expanded: 1 → 5 locations
    • Collaborators: 6 to 4
    • Publications: details revised at 1 of 1 entry
  3. Trial status: Enrolling by Invitation to Recruiting
    • Site details revised
    v3
  4. Study title shortened, about 15 wordsv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study investigates the impact of a nudge-based intervention on improving 2026 European Society of Cardiology guideline class I Foundational Medical Therapy (FMT) and Additional medical therapy (AMT) 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.
Trial Details
NCT Number NCT06844006
Lead Sponsor Medisch Spectrum Twente
Collaborators: Onze Lieve Vrouwe Gasthuis, St. Antonius Hospital, Catharina Ziekenhuis Eindhoven, Maasstad Hospital
Conditions
(from sponsor)		 Heart Failure
Related terms Heart Failure
Enrollment 1,320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov