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 [version 2; peer review: 2 approved]
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 tra...
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Wellcome
2023-07-01
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| Series: | Wellcome Open Research |
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| Online Access: | https://wellcomeopenresearch.org/articles/8-197/v2 |
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| author | Sajan Ahmad Rajeev Edakutty Eapen Punnoose Sunu C Thomas Shafeeq Mattummal Johny Joseph N Syam Sunil Pisharody Veena Nanjappa Stigi Joseph Tiny Nair Vijo George Vijayan Ganesan Sivadasanpillai Harikrishnan Susanna Chacko Sanjay Ganapathi Jabir Abdullakutty Panniyammakal Jeemon Devaraju Chandgalu Javaregowda Charantharalyil Gopalan Bahuleyan Govindan Unni Gopalan Rajendiran Justin Paul Gnanaraj Jayakumar Balakrishnan Meera R Pillai Madhu Sreedharan Paul Thomas Neenumol KR Rachel Daniel Placid Sebastian |
| author_facet | Sajan Ahmad Rajeev Edakutty Eapen Punnoose Sunu C Thomas Shafeeq Mattummal Johny Joseph N Syam Sunil Pisharody Veena Nanjappa Stigi Joseph Tiny Nair Vijo George Vijayan Ganesan Sivadasanpillai Harikrishnan Susanna Chacko Sanjay Ganapathi Jabir Abdullakutty Panniyammakal Jeemon Devaraju Chandgalu Javaregowda Charantharalyil Gopalan Bahuleyan Govindan Unni Gopalan Rajendiran Justin Paul Gnanaraj Jayakumar Balakrishnan Meera R Pillai Madhu Sreedharan Paul Thomas Neenumol KR Rachel Daniel Placid Sebastian |
| author_sort | Sajan Ahmad |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T20:22:45Z |
| format | Article |
| id | doaj.art-d714dc2930f5419e89005f46684d597a |
| institution | Directory Open Access Journal |
| issn | 2398-502X |
| language | English |
| last_indexed | 2024-03-11T20:22:45Z |
| publishDate | 2023-07-01 |
| publisher | Wellcome |
| record_format | Article |
| series | Wellcome Open Research |
| spelling | doaj.art-d714dc2930f5419e89005f46684d597a2023-10-03T01:00:01ZengWellcomeWellcome Open Research2398-502X2023-07-01821784Team 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 [version 2; peer review: 2 approved]Sajan Ahmad0Rajeev Edakutty1Eapen Punnoose2Sunu C Thomas3Shafeeq Mattummal4Johny Joseph5N Syam6Sunil Pisharody7Veena Nanjappa8Stigi Joseph9Tiny Nair10Vijo George11Vijayan Ganesan12Sivadasanpillai Harikrishnan13Susanna Chacko14https://orcid.org/0000-0001-8129-102XSanjay Ganapathi15Jabir Abdullakutty16Panniyammakal Jeemon17https://orcid.org/0000-0003-4172-4307Devaraju Chandgalu Javaregowda18https://orcid.org/0000-0002-0182-9772Charantharalyil Gopalan Bahuleyan19Govindan Unni20Gopalan Rajendiran21Justin Paul Gnanaraj22https://orcid.org/0000-0002-8588-5594Jayakumar Balakrishnan23Meera R Pillai24Madhu Sreedharan25Paul Thomas26Neenumol KR27Rachel Daniel28Placid Sebastian29St Gregorios Memorial Mission Hospital, Parumala, Kerala, IndiaDistrict Cooperative Hospital, Calicut, Kerala, IndiaMalankara Orthodox Syrian Church Medical College, Kolenchery, Kerala, IndiaSree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, 695011, IndiaAster MIMS, Calicut, Kerala, IndiaCaritas Hospital, Kottayam, Kerala, IndiaGovernment District Hospital, Kollam, Kerala, IndiaEMS Memorial Cooperative Hospital and Research Centre Ltd, Malappuram, Kerala, IndiaSri Jayadeva Institute of Cardiovascular Science and Research, Mysore, Karnataka, IndiaLittle Flower Hospital and Research Centre, Angamaly, Ernakulam, Kerala, IndiaPRS Hospital, Thiruvananthapuram, Kerala, IndiaGeneral Hospital, Ernakulam, Kerala, IndiaAster MIMS, Kannur, Kerala, IndiaSree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, 695011, IndiaSree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, 695011, IndiaSree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, 695011, IndiaLisie Hospital, Ernakulam, Kerala, IndiaSree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, 695011, IndiaSri Jayadeva Institute of Cardiovascular Science and Research, Mysore, Karnataka, IndiaAnanthapuri Hospitals and Research Institute, Thiruvananthapuram, Kerala, IndiaJubilee Mission medical College and Research Institute, Thrissur, Kerala, IndiaPSG Institute of Medical Sciences, Coimbatore, Tamilnadu, IndiaRajiv Gandhi Government General Hospital, Madras Medical College, Chennai, Tamilnadu, IndiaThangam Hospital of PMRC, Palakkad, Kerala, IndiaKIMS Hospital, Thiruvananthapuram, Kerala, IndiaNIMS Heart Foundation, NIMS Medicity, Thiruvananthapuram, Kerala, IndiaGeneral Hospital, Ernakulam, Kerala, IndiaSree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, 695011, IndiaNS Memorial Institute of Medical Sciences, Kollam, Kerala, IndiaAster MIMS, Kannur, Kerala, IndiaBackground: 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.https://wellcomeopenresearch.org/articles/8-197/v2Heart failure collaborative care model mhealth application cluster randomised controlled trialeng |
| spellingShingle | Sajan Ahmad Rajeev Edakutty Eapen Punnoose Sunu C Thomas Shafeeq Mattummal Johny Joseph N Syam Sunil Pisharody Veena Nanjappa Stigi Joseph Tiny Nair Vijo George Vijayan Ganesan Sivadasanpillai Harikrishnan Susanna Chacko Sanjay Ganapathi Jabir Abdullakutty Panniyammakal Jeemon Devaraju Chandgalu Javaregowda Charantharalyil Gopalan Bahuleyan Govindan Unni Gopalan Rajendiran Justin Paul Gnanaraj Jayakumar Balakrishnan Meera R Pillai Madhu Sreedharan Paul Thomas Neenumol KR Rachel Daniel Placid Sebastian 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 [version 2; peer review: 2 approved] Wellcome Open Research Heart failure collaborative care model mhealth application cluster randomised controlled trial eng |
| title | 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 [version 2; peer review: 2 approved] |
| title_full | 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 [version 2; peer review: 2 approved] |
| title_fullStr | 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 [version 2; peer review: 2 approved] |
| title_full_unstemmed | 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 [version 2; peer review: 2 approved] |
| title_short | 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 [version 2; peer review: 2 approved] |
| title_sort | 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 version 2 peer review 2 approved |
| topic | Heart failure collaborative care model mhealth application cluster randomised controlled trial eng |
| url | https://wellcomeopenresearch.org/articles/8-197/v2 |
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