title: Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  CTRI/2013/04/003557.
authors.affiliation: The George Institute for Global Health, Sydney, New South Wales, Australia Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Hueiming
authors.initials: H
authors.lastname: Liu
authors.affiliation: The George Institute for Global Health, Sydney, New South Wales, Australia Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Richard
authors.initials: R
authors.lastname: Lindley
authors.affiliation: George Institute for Global Health, Hyderabad, Telangana, India.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Alim
authors.affiliation: Christian Medical College, Ludhiana, Punjab, India.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Felix
authors.affiliation: Christian Medical College, Ludhiana, Punjab, India.
authors.forename: Dorcas B C
authors.initials: DB
authors.lastname: Gandhi
authors.affiliation: Christian Medical College, Ludhiana, Punjab, India.
authors.forename: Shweta J
authors.initials: SJ
authors.lastname: Verma
authors.affiliation: Indian Institute of Public Health, Hyderabad, Telangana, India.
authors.forename: Deepak Kumar
authors.initials: DK
authors.lastname: Tugnawat
authors.affiliation: Indian Institute of Public Health, Hyderabad, Telangana, India.
authors.forename: Anuradha
authors.initials: A
authors.lastname: Syrigapu
authors.affiliation: College of Allied Health Sciences, Gulf Medical University, Ajman, UAE.
authors.forename: Ramaprabhu Krishnappa
authors.initials: RK
authors.lastname: Ramamurthy
authors.affiliation: Christian Medical College, Ludhiana, Punjab, India.
authors.forename: Jeyaraj D
authors.initials: JD
authors.lastname: Pandian
authors.affiliation: University of Nottingham, Nottingham, UK.
authors.forename: Marion
authors.initials: M
authors.lastname: Walker
authors.affiliation: University of Leeds, West Yorkshire, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Forster
authors.affiliation: The George Institute for Global Health, Sydney, New South Wales, Australia Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.
authors.forename: Craig S
authors.initials: CS
authors.lastname: Anderson
authors.affiliation: University of Glasgow, Glasgow, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Langhorne
authors.affiliation: Indian Institute of Public Health, Hyderabad, Telangana, India.
authors.forename: Gudlavalleti Venkata Satyanarayana
authors.initials: GV
authors.lastname: Murthy
authors.affiliation: School of Medical Sciences, University of Hyderabad, Hyderabad, Telangana, India.
authors.forename: Bindiganavale Ramaswamy
authors.initials: BR
authors.lastname: Shamanna
authors.affiliation: The George Institute for Global Health, Sydney, New South Wales, Australia.
authors.forename: Maree L
authors.initials: ML
authors.lastname: Hackett
authors.affiliation: George Institute for Global Health, Hyderabad, Telangana, India The George Institute for Global Health, Oxford University, Oxford, UK.
authors.forename: Pallab K
authors.initials: PK
authors.lastname: Maulik
authors.affiliation: Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Harvey
authors.affiliation: The George Institute for Global Health, Sydney, New South Wales, Australia Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Jan
mesh_terms: D001291:Attitude of Health Personnel; D017028:Caregivers / Q000193:education*; D003362:Cost-Benefit Analysis; D003906:Developing Countries; D006233:Persons with Disabilities; D005069:Evaluation Studies as Topic; D005190:Family; D005102:Health Expenditures; D006801:Humans; D007194:India; D017064:Process Assessment, Health Care; D012107:Research Design; D020521:Stroke; D000071939:Stroke Rehabilitation / Q000191:economics
keywords: QUALITATIVE RESEARCH; REHABILITATION MEDICINE