Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India
Introduction We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective int...
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BMJ Publishing Group
2016
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| author | Liu, Hueiming Lindley, Richard Alim, Mohammed Felix, Cynthia Gandhi, Dorcas B.C. Verma, Schweta J. Tugnawat, Deepak Kumar Syrigapu, Anuradha Ramamurthy, Ramaprabhu Krishnappa Pandian, Jeyaraj D. Walker, Marion F. Forster, Anne Anderson, Craig S. Langhorne, Peter Murthy, Gudlavalleti Venkata Satyanarayana Shamanna, Bindiganavale Ramaswamy Hackett, Maree L. Maulik, Pallab K, Harvey, Lisa A. Jan, Stephen |
| author_facet | Liu, Hueiming Lindley, Richard Alim, Mohammed Felix, Cynthia Gandhi, Dorcas B.C. Verma, Schweta J. Tugnawat, Deepak Kumar Syrigapu, Anuradha Ramamurthy, Ramaprabhu Krishnappa Pandian, Jeyaraj D. Walker, Marion F. Forster, Anne Anderson, Craig S. Langhorne, Peter Murthy, Gudlavalleti Venkata Satyanarayana Shamanna, Bindiganavale Ramaswamy Hackett, Maree L. Maulik, Pallab K, Harvey, Lisa A. Jan, Stephen |
| author_sort | Liu, Hueiming |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Introduction We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting.
Methods and analysis The realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation.
Ethics and dissemination The process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation.
Trial registration number CTRI/2013/04/003557. |
| first_indexed | 2025-11-14T19:33:27Z |
| format | Article |
| id | nottingham-37739 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:33:27Z |
| publishDate | 2016 |
| publisher | BMJ Publishing Group |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-377392020-05-04T18:12:16Z https://eprints.nottingham.ac.uk/37739/ Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India Liu, Hueiming Lindley, Richard Alim, Mohammed Felix, Cynthia Gandhi, Dorcas B.C. Verma, Schweta J. Tugnawat, Deepak Kumar Syrigapu, Anuradha Ramamurthy, Ramaprabhu Krishnappa Pandian, Jeyaraj D. Walker, Marion F. Forster, Anne Anderson, Craig S. Langhorne, Peter Murthy, Gudlavalleti Venkata Satyanarayana Shamanna, Bindiganavale Ramaswamy Hackett, Maree L. Maulik, Pallab K, Harvey, Lisa A. Jan, Stephen Introduction We are undertaking a randomised controlled trial (fAmily led rehabiliTaTion aftEr stroke in INDia, ATTEND) evaluating training a family carer to enable maximal rehabilitation of patients with stroke-related disability; as a potentially affordable, culturally acceptable and effective intervention for use in India. A process evaluation is needed to understand how and why this complex intervention may be effective, and to capture important barriers and facilitators to its implementation. We describe the protocol for our process evaluation to encourage the development of in-process evaluation methodology and transparency in reporting. Methods and analysis The realist and RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) frameworks informed the design. Mixed methods include semistructured interviews with health providers, patients and their carers, analysis of quantitative process data describing fidelity and dose of intervention, observations of trial set up and implementation, and the analysis of the cost data from the patients and their families perspective and programme budgets. These qualitative and quantitative data will be analysed iteratively prior to knowing the quantitative outcomes of the trial, and then triangulated with the results from the primary outcome evaluation. Ethics and dissemination The process evaluation has received ethical approval for all sites in India. In low-income and middle-income countries, the available human capital can form an approach to reducing the evidence practice gap, compared with the high cost alternatives available in established market economies. This process evaluation will provide insights into how such a programme can be implemented in practice and brought to scale. Through local stakeholder engagement and dissemination of findings globally we hope to build on patient-centred, cost-effective and sustainable models of stroke rehabilitation. Trial registration number CTRI/2013/04/003557. BMJ Publishing Group 2016-09-15 Article PeerReviewed Liu, Hueiming, Lindley, Richard, Alim, Mohammed, Felix, Cynthia, Gandhi, Dorcas B.C., Verma, Schweta J., Tugnawat, Deepak Kumar, Syrigapu, Anuradha, Ramamurthy, Ramaprabhu Krishnappa, Pandian, Jeyaraj D., Walker, Marion F., Forster, Anne, Anderson, Craig S., Langhorne, Peter, Murthy, Gudlavalleti Venkata Satyanarayana, Shamanna, Bindiganavale Ramaswamy, Hackett, Maree L., Maulik, Pallab K,, Harvey, Lisa A. and Jan, Stephen (2016) Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India. BMJ, 6 (e01202). pp. 1-8. ISSN 1756-1833 Stroke randomized controlled trial protocol India http://bmjopen.bmj.com/content/6/9/e012027 doi:10.1136/bmjopen-2016-012027 doi:10.1136/bmjopen-2016-012027 |
| spellingShingle | Stroke randomized controlled trial protocol India Liu, Hueiming Lindley, Richard Alim, Mohammed Felix, Cynthia Gandhi, Dorcas B.C. Verma, Schweta J. Tugnawat, Deepak Kumar Syrigapu, Anuradha Ramamurthy, Ramaprabhu Krishnappa Pandian, Jeyaraj D. Walker, Marion F. Forster, Anne Anderson, Craig S. Langhorne, Peter Murthy, Gudlavalleti Venkata Satyanarayana Shamanna, Bindiganavale Ramaswamy Hackett, Maree L. Maulik, Pallab K, Harvey, Lisa A. Jan, Stephen Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India |
| title | Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India |
| title_full | Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India |
| title_fullStr | Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India |
| title_full_unstemmed | Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India |
| title_short | Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India |
| title_sort | protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (attend) in india |
| topic | Stroke randomized controlled trial protocol India |
| url | https://eprints.nottingham.ac.uk/37739/ https://eprints.nottingham.ac.uk/37739/ https://eprints.nottingham.ac.uk/37739/ |