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): design and rationale of a parallel group, open label, multi-centric cluster randomised controlled trial
Key result
TIME-HF tests a team-based collaborative care model for survival and DAOH in heart failure.
- n=1,500
Why the study?
Heart failure management is complex and requires care-coordination across health care providers, prompting the need to evaluate a team-based collaborative care model supported by mHealth in India.
Does a team-based collaborative care model facilitated by trained nurses and mHealth improve overall survival and days alive and out of hospital in patients with heart failure with reduced ejection fraction?
Population
More than 1500 HF patients across 22 tertiary-care hospitals in India
Comparison
Team-based collaborative care model facilitated by trained nurses with mHealth support vs not specified
Design
Parallel group, open-label, multicentric cluster randomised controlled trial
Follow-up
Two-years
Authors
Discussion
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Member takes
Implication
Will test nurse-mHealth collaborative care on HFrEF survival in India; first RCT to extend this model to resource-limited settings.
Study Design
Type
RCT (n=1,500)
Blinding
Open-label
Randomization
Cluster
Multicenter
Yes
Structured PICO
Does a team-based collaborative care model facilitated by trained nurses and mHealth improve overall survival and days alive and out of hospital in patients with heart failure with reduced ejection fraction?
P
Population
More than 1500 patients with heart failure with reduced ejection fraction across 22 tertiary-care hospitals in India
I
Intervention
Team based collaborative care model (CCM), facilitated by trained nurses, with the support of mHealth
O
Outcome
Overall survival as well as days alive and out of hospital (DAOH) at two-yearshard clinical
The TIME-HF trial protocol outlines a study to evaluate whether a nurse-facilitated, mHealth-supported collaborative care model improves survival and days alive and out of hospital for patients with HFrEF in India.
Cite This Study
Jeemon et al. (2023) conducted an RCT in Heart failure with reduced ejection fraction (n=1,500). Team based collaborative care model (CCM) with mHealth support was evaluated on Overall survival and days alive and out of hospital (DAOH). The TIME-HF trial is a cluster randomized controlled trial designed to evaluate the efficacy of a team-based collaborative care model in over 1500 patients with heart failure in India.