BACKGROUND: Heart failure with reduced ejection fraction causes high mortality and recurrent hospitalizations in India. We evaluated the effectiveness of the collaborative care model in improving days alive and out of the hospital and overall survival.
METHODS: We conducted a parallel-group, cluster-randomized controlled trial involving 1507 adults with heart failure with reduced ejection fraction across 22 centers in India (CTRI/2021/11/037797). Centers were randomized 1:1 to the intervention or usual care. Participants were followed up for 2 years. The intervention included risk stratification, lifestyle and pharmacological optimization, and a nurse-coordinated, mobile health-supported disease management program with self-care education, active follow-up, and continuous outpatient monitoring throughout the study period. The primary outcome was days alive and out of the hospital, and all-cause mortality was assessed as a secondary outcome. Days alive and out of the hospital was analyzed with a one-inflated ß model. All-cause mortality was analyzed with Cox proportional hazards models adjusted for the clustered study design.
RESULTS: Among 1507 participants (752 usual care; 755 intervention), the mean age was 61.9 years, and 77.6% were men. All participants except one completed 24 months of follow-up. Most participants (70%) had low educational attainment; 57.3% lived in rural areas; and ischemic heart disease was the predominant cause (77.4%). Baseline characteristics were comparable between the intervention and usual care groups. In the one-inflated ß model, the probability of surviving up to 730 days without hospitalization was 34.7% (95% CI, 31.2%-38.1%) in the usual care group and 46.5% (95% CI, 42.6%-49.9%) in the intervention group. Participants in the intervention group had 78% higher odds of achieving a percent days alive and out of the hospital of exactly 1 (730/730 days) compared with those in the usual care group (odds ratio, 1.78 [95% CI, 1.42-2.23]). There were 201 deaths (26.73%) in the usual care group compared with 163 deaths (21.59%) in the intervention group (risk ratio, 0.80 [95% CI, 0.67-0.97]). In the multivariable Cox proportional hazards model, the intervention group had a 22% lower mortality risk than the usual care group (hazard ratio, 0.78 [95% CI, 0.63-0.95]; P=0.028).
CONCLUSIONS: A nurse-coordinated, mobile health-supported collaborative care model for heart failure with reduced ejection fraction in India increased the number of days alive and out of hospital, raised the absolute probability of remaining out of hospital by 11.8 percentage points, and reduced all-cause mortality by 22%.
REGISTRATION: URL: www.ctri.nic.in; Unique identifier: CTRI/2021/11/037797.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
In this cluster-randomized trial, patients randomized to intensive nurse follow-up had better clearance of GDMT, fewer rehospitalizations, and a mortality benefit. In cluster designs, it’s possible differences between sites could explain this. Researchers should test the outcomes in other settings where usual care includes more intensive follow-up to determine which parts of the intervention are beneficial.
Physician rater
While the investigators were able to create an effective interdisciplinary model, the context of their implementation (India) is probably different enough from my US practice that the findings may not be directly applicable.
Physician rater
As a primary care doctor, these results were surprising. The benefit is that the data findings from 22 cluster-randomized areas in rural India show that there is a 78% odds of days alive out of the hospital for heart failure with reduced ejection fraction 95% confidence interval: 2.3 to 6.8) if nurses collaborated to deliver heart failure interventional care, compared with usual heart failure care. This article provides preliminary evidence to be triangulated in other rural settings around the world.
Mr. CHRISTIAN MATONDO (9/25/2026 10:27 AM)
Translated by Google Translate: Congratulations on your article that provides us with more information. Original comment: Félicitations pour votre article qui nous renseigne plus.
, McMaster University