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IntroductionMonitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.Methods and analysisConsecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.Ethics and disseminationThe protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.Trial registration numberCTRI/2024/06/068838.

Background The steep increase in knee arthroplasties in lower- and middle-income countries has increased demand for personalised rehabilitation care. Technology-based rehabilitation programs offer potential to replace or augment conventional face-to-face rehabilitation for providing continuum of care. We aimed to systematically develop a theory, evidence-driven, contextualised, and user-centred mobile health platform for people undergoing knee arthroplasty to facilitate monitoring progress during rehabilitation. Methods We followed the UK Medical Research Council’s framework and adopted a behaviour design thinking approach, consisting of five steps; (1) conduct multiple literature reviews and cross-sectional surveys to determine the needs and problems experienced during the rehabilitation phase by healthcare professionals and individuals with replaced knees, (2) identify target behaviours along with barriers and facilitators, integrated within the Capability, Opportunity, Motivation-Behaviour (COM-B) framework, (3) identify intervention functions and components, behaviour change techniques, and features for the mobile application, selected after discussions with orthopaedic surgeons, physiotherapists and behavioural experts, (4) develop a prototype application for end-users, and a web-based platform for healthcare professionals, and (5) pilot test the intervention for end-users’ feedback on usability of the application and to identify possible strategies for implementing the intervention package. Results Using the COM-B model, education, training, persuasion, enablement, and modelling were chosen as intervention functions for improving adherence to exercise protocol during early-phase of rehabilitation. The application featured five interlinked components; education, training, goal setting and self-management, communication, and a personalized therapy plan utilising 13 behaviour change techniques. An education booklet, exercise videos, text messaging, video consultation, and a digital tool for measuring range of motion were incorporated into the application. Feedback on the interactive prototype and education material was sought from ten patient volunteers and a physiotherapist. Pilot testing in a convenient sample with broad eligibility criteria ( n  = 30) indicated importance of digital literacy and dedicated time for remote consultation by healthcare provider within the existing clinical work. Overall, the intervention was well received and valued by the end users. Conclusion This paper demonstrates the development of a contextualised digital behavioural intervention grounded in behavioural theory and evidence from literature to improve end-user’s engagement with rehabilitation protocols after knee arthroplasty in lower- and middle-income country context. Trial registration Study registered prospectively (on 16 February 2023) at Clinical Trials Registry of India (CTRI/2023/02/049792).

Recent years have witnessed an increase in the use of technology-enabled interventions for delivering mental health care in different settings. Technological solutions have been advocated to increase access to care, especially in primary health care settings in low- and middle-income countries, to facilitate task-sharing given the lack of trained mental health professionals. This report describes the experiences and challenges faced during the development and implementation of technology-enabled interventions for mental health among adults and adolescents in rural and urban settings of India. A detailed overview of the technological frameworks used in various studies, including the Systematic Medical Appraisal and Referral Treatment (SMART) Mental Health pilot study, SMART Mental Health cluster randomized controlled trial, and Adolescents' Resilience and Treatment Needs for Mental Health in Indian Slums (ARTEMIS) study, is provided. This includes the mobile apps that were used to collect data and the use of the database to store the data that were collected. Based on the experiences faced, the technological enhancements and adaptations made at the mobile app and database levels are described in detail. Development of descriptive analytics at the database level; enabling offline and online data storage modalities; customizing the Open Medical Record System platform to suit the study requirements; modifying the encryption settings, thereby making the system more secure; and merging different apps for simultaneous data collection were some of the enhancements made across different projects. Technology-enabled interventions prove to be a useful solution to cater to large populations in low-resource settings. The development of mobile apps is subject to the context and the area where they would be implemented. This paper outlines the need for careful testing using an iterative process that may support future research using similar technology. SMART Mental Health trial: Clinical Trial Registry India CTRI/2018/08/015355; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MjMyNTQ=&Enc=&userName=CTRI/2018/08/015355. ARTEMIS trial: Clinical Trial Registry India CTRI/2022/02/040307; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NDcxMTE=&Enc=&userName=CTRI/2022/02/040307.