Jeemon Panniyammakal, Bahuleyan Charantharalyil Gopalan, Chandgalu Javaregowda Devaraju, Punnoose Eapen, Rajendiran Gopalan, Unni Govindan, Abdullakutty Jabir, Balakrishnan Jayakumar, Joseph Johny, Gnanaraj Justin Paul, Sreedharan Madhu, Pillai Meera R, Kr Neenumol, Thomas Paul, Sebastian Placid, Daniel Rachel, Edakutty Rajeev, Ahmad Sajan, Mattummal Shafeeq, Thomas Sunu C, Joseph Stigi, Pisharody Sunil, Chacko Susanna, Syam N, Nair Tiny, Nanjappa Veena, Ganesan Vijayan, George Vijo, Ganapathi Sanjay, Harikrishnan Sivadasanpillai
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, 695011, India.
Ananthapuri Hospitals and Research Institute, Thiruvananthapuram, Kerala, India.
Wellcome Open Res. 2023 Jul 12;8:197. doi: 10.12688/wellcomeopenres.19196.2. eCollection 2023.
Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care-coordination with different cadres of health care providers. We propose to develop a team based collaborative care model (CCM), facilitated by trained nurses, for management of HF with the support of mHealth and evaluate its acceptability and effectiveness in Indian setting. The proposed study will use mixed-methods research. Formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary-care hospitals) and more than 1500 HF patients will be conducted to assess the efficacy of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through both qualitative and quantitative process evaluation methods. The TIME-HF trial will provide evidence on whether a CCM with mHealth support is effective in improving the clinical outcomes of HF with reduced ejection fraction in India. The findings may change the practice of management of HF in low and middle-income countries.
心力衰竭（HF）是一种使人衰弱的疾病，伴随着巨大的公共卫生负担。HF的管理很复杂，因为它需要与不同类型的医疗保健提供者进行护理协调。我们建议在经过培训的护士的协助下，开发一种基于团队的协作护理模式（CCM），在移动健康（mHealth）的支持下管理HF，并评估其在印度环境中的可接受性和有效性。拟议的研究将采用混合方法研究。形成性定性研究将确定实施CCM管理HF的障碍和促进因素。随后，将进行一项涉及22个中心（三级护理医院）和1500多名HF患者的整群随机对照试验（RCT），以评估CCM在提高总体生存率以及两年内存活且出院天数（DAOH）方面的疗效（CTRI/2021/11/037797）。DAOH将通过从总随访时间中减去住院天数以及从死亡到研究随访结束的天数来计算。在DAOH分析中将采用具有稳健方差估计和偏移项以考虑聚类的泊松回归。将估计率比及其95%置信区间（CI）。将通过经济分析（成本效益）评估拟议干预模型的可扩展性，并通过定性和定量过程评估方法了解干预在提供者和患者层面的可接受性。TIME-HF试验将提供证据，证明在印度，一种有mHealth支持的CCM是否能有效改善射血分数降低的HF的临床结局。这些发现可能会改变低收入和中等收入国家HF的管理实践。
