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
-
Published:2023-07-12
Issue:
Volume:8
Page:197
-
ISSN:2398-502X
-
Container-title:Wellcome Open Research
-
language:en
-
Short-container-title:Wellcome Open Res
Author:
Jeemon PanniyammakalORCID, Bahuleyan Charantharalyil Gopalan, Chandgalu Javaregowda DevarajuORCID, Punnoose Eapen, Rajendiran Gopalan, Unni Govindan, Abdullakutty Jabir, Balakrishnan Jayakumar, Joseph Johny, Gnanaraj Justin PaulORCID, 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 SusannaORCID, Syam N, Nair Tiny, Nanjappa Veena, Ganesan Vijayan, George Vijo, Ganapathi Sanjay, Harikrishnan Sivadasanpillai
Abstract
Background: 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. Methods: 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. Potential Impact: 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.
Funder
The Wellcome Trust DBT India Alliance
Publisher
F1000 Research Ltd
Subject
General Biochemistry, Genetics and Molecular Biology,Medicine (miscellaneous)
|
|