TIME-HF
Team based collaborative care model, facilitated by mHealth enabled and trained nurses, for management of heart failure with reduced ejection fraction in India (TIME-HF)
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 1,500 patients with HFrEF at 22 hospitals in India, nurse-led, app-supported collaborative care was compared with usual care on days alive and out of hospital over 2 years.
N
1.500
Design
parallel-group, open-label, multicentre cluster-randomised controlled trial; 22 hospital units in India randomised 1:1 by computer-generated sequence (no blocking or matching) to intervention or usual care; about 70 patients per centre (≈770 per arm); rolling recruitment over 6–12 months; 2-year follow-up per patient
Endpunkt
Days alive and out of hospital (DAOH) during 2 years of follow-up (total follow-up time minus days in hospital and days from death to end of follow-up)