Enhancing Guideline-Directed Medical Therapy at Discharge Through Collaborative Care: Evidence from the TIME-HF Cluster Randomized Controlled Trial

Background Nurse-led care supported by mobile health (mHealth) technologies offers a feasible strategy to strengthen heart failure (HF) management in resource-constrained settings. This study evaluated the impact of an mHealth-enabled, nurse-led collaborative care model on prescription of guideline-directed medical therapy (GDMT) at discharge among patients with heart failure with reduced ejection fraction (HFrEF) in India. Methods The TIME-HF study was a multicenter, open-label, cluster-randomized controlled trial conducted across 22 centers enrolling patients with HFrEF. Centers were randomized 1:1 to an intervention arm (11 centers; 755 patients) or enhanced usual care (11 centers; 752 patients). In the intervention arm, nurses used an mHealth application to review GDMT prescriptions and recommend treatment modifications to physicians. GDMT at discharge was assessed individually and using a composite score. Intervention effects were evaluated using multivariable mixed-effects logistic regression models. Results Participants were predominantly male (77.6%) with a mean age of 61.9 years (SD 12.1). Hypertension (56.1%), diabetes (62%), and chronic kidney disease (18.4%) were common comorbidities. Ischemic heart disease was the leading etiology (77.4%), and 48.8% were in NYHA class III/IV. Baseline characteristics were similar between groups. At discharge, 20% received all four GDMT components, with higher use in the intervention group than usual care (27% vs 13%, p < 0.001; adjusted OR 1.61, 95% CI 1.48–1.75). Intervention participants were also more likely to achieve a high GDMT score (OR 1.13, 95% CI 1.04–1.22). Conclusion An mHealth-supported nurse-led discharge medication review improved GDMT use in HFrEF and may help reduce preventable HF mortality in India. Trial registration: Clinical Trial Registry of India (CTRI/2021/11/037797), Registered on 03/11/2021; the study is ongoing.

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Journal
Wellcome Open Research
Published
2026-09-11
DOI
https://doi.org/10.12688/wellcomeopenres.26369.2
Primary Topic
Heart Failure Treatment and Management
Type
article
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0.00

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article

Enhancing Guideline-Directed Medical Therapy at Discharge Through Collaborative Care: Evidence from the TIME-HF Cluster Randomized Controlled Trial

Meera R Pillai, Sunil Pisharody, Vijo George, Panniyammakal Jeemon et al.
Wellcome Open Research
Heart Failure Treatment and Management
article

Enhancing Guideline-Directed Medical Therapy at Discharge Through Collaborative Care: Evidence from the TIME-HF Cluster Randomized Controlled Trial

Meera R Pillai, Sunil Pisharody, Vijo George, Panniyammakal Jeemon, Placid Sebastian, G. Justin Paul, Salman Salahuddin, Madhu Sreedharan, Shafeeq Mattummal, Sunaib Ismail, Jayakumar Balakrishnan, Rajeev Edakutty, Mahesh Nalin Kumar, Johny Joseph, Anu Mary Chacko, Joyal J. Kandathil, Govindan Unni, Vijayan Ganesan, Athira Thottathan, Veena Nanjappa, Bahuleyan Charantharalyil Gopalan, Reshmy Mohan, Sajan Ahmad, Chandgalu Javaregowda Devaraju, Mariyam Alex, Safvan Karkuzhiyil, Eapen Punnoose, Rachel Daniel, Natesan Syam, Paul Thomas, Gopalan Rajendiran, Sivadasanpillai Harikrishnan, Jabir Abdullakutty, Tiny Nair, Stigi Joseph, Sanjay Ganapathi
article en

Abstract

Background Nurse-led care supported by mobile health (mHealth) technologies offers a feasible strategy to strengthen heart failure (HF) management in resource-constrained settings. This study evaluated the impact of an mHealth-enabled, nurse-led collaborative care model on prescription of guideline-directed medical therapy (GDMT) at discharge among patients with heart failure with reduced ejection fraction (HFrEF) in India. Methods The TIME-HF study was a multicenter, open-label, cluster-randomized controlled trial conducted across 22 centers enrolling patients with HFrEF. Centers were randomized 1:1 to an intervention arm (11 centers; 755 patients) or enhanced usual care (11 centers; 752 patients). In the intervention arm, nurses used an mHealth application to review GDMT prescriptions and recommend treatment modifications to physicians. GDMT at discharge was assessed individually and using a composite score. Intervention effects were evaluated using multivariable mixed-effects logistic regression models. Results Participants were predominantly male (77.6%) with a mean age of 61.9 years (SD 12.1). Hypertension (56.1%), diabetes (62%), and chronic kidney disease (18.4%) were common comorbidities. Ischemic heart disease was the leading etiology (77.4%), and 48.8% were in NYHA class III/IV. Baseline characteristics were similar between groups. At discharge, 20% received all four GDMT components, with higher use in the intervention group than usual care (27% vs 13%, p < 0.001; adjusted OR 1.61, 95% CI 1.48–1.75). Intervention participants were also more likely to achieve a high GDMT score (OR 1.13, 95% CI 1.04–1.22). Conclusion An mHealth-supported nurse-led discharge medication review improved GDMT use in HFrEF and may help reduce preventable HF mortality in India. Trial registration: Clinical Trial Registry of India (CTRI/2021/11/037797), Registered on 03/11/2021; the study is ongoing.

Wellcome Open ResearchVol. 11
ASTER (CA), University of Calicut (IN), National Institute of Technology Calicut (IN), PSG Institute of Medical Sciences & Research (IN), Sree Chitra Thirunal Institute for Medical Sciences and Technology (IN), Almas Hospital (IN), Jubilee Mission Medical College and Research Institute (IN), Government of Kerala (IN), General Hospital Ernakulam (IN), Government General Hospital (IN), Malankara Orthodox Syrian Church Medical College Hospital (IN), Caritas Hospital (IN), Sri Jayadeva Institute of Cardiovascular Sciences and Research (IN), Lourdes Hospital (IN), Government Medical College and Hospital (IN), Indian Institute of Technology Palakkad (IN), Ananthapuri Hospitals and Research Institute (IN), Little Flower Hospital & Research Centre (IN), Kerala Institute of Medical Sciences (IN), Memorial Hospital (US), Kannur University (IN)
The Wellcome Trust DBT India Alliance
Openalex Percentile: Top 11%
Heart Failure Treatment and Management
DOIOpen Access PDFOpenAlex
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