Assessment of Digital Care on Clinical Impact and Efficiency Using a Stepped Wedge Cluster RCT in Heart Failure Patients: the ADMINISTER II Trial
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• All heart failure diagnoses
• \>18 years
Locations
Other Locations
Netherlands
Medisch Spectrum Twente
RECRUITING
Enschede
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 1320
Treatments
Other: Intervention
All cardiologists will be nudged during the trial. with the use of a stepped wedge design there will be a structured embedding in the current standard of care.
Related Therapeutic Areas
Sponsors
Collaborators: Maasstad Hospital, Rotterdam, Catharina Ziekenhuis Eindhoven, St. Antonius Hospital, Canisius Wilhelmina Ziekenhuis (CWZ), Martini Hospital Groningen, Onze Lieve Vrouwe Gasthuis
Leads: Medisch Spectrum Twente