Chronic dyspnoea is a prevalent symptom, and primary care is ideally placed to identify and manage it. However, chronic dyspnoea is under-reported by patients and can be a diagnostic dilemma for practitioners. A fully automated system of patient screening, coupled with a clinical decision support system (CDSS) that uses a validated and evidence-based dyspnoea algorithm, may improve detection, diagnosis and management of the condition. There is currently no CDSS validated for chronic dyspnoea diagnosis and management in primary care in Australia. The objectives of this study are to assess the clinical impact of a CDSS for chronic dyspnoea in primary care. We hypothesise that the use of the CDSS will lead to a clinically significant improvement in patient-reported dyspnoea scores, reduced time to diagnosis and healthcare costs at 12 months compared with standard care.

The BREATHE study is an open-label, cluster-randomised controlled trial of standard of care compared with a CDSS. General practices (n=40) in metropolitan, regional/rural and rural/remote settings will be recruited and randomised equally to pre-screening for chronic dyspnoea and usual standard-of-care management or pre-screening and CDSS-guided management. The CDSS includes an algorithm derived from a robust data and clinical knowledge model and incorporates evidence-based recommendations for the assessment and management of chronic dyspnoea. It is integrated into general practice medical software systems, fitting in the workflow of general practitioners (GPs). Eligible patients will be ≥18 years old and will have previously consented to receive SMS communication from their practice. In-scope patients will receive an automated text message prior to their GP appointment and will be screened for chronic dyspnoea (≥4 weeks). Patients identified with chronic dyspnoea will be invited to participate in the BREATHE study and followed up for 12 months. The primary outcome is improvement in the Dyspnoea-12 (D-12) score from baseline to 12 months, measured by the Dyspnoea-12 (D-12) questionnaire. Secondary outcomes include disease-specific questionnaires to assess changes in clinical outcomes, time to final diagnosis, quality of life, healthcare utilisation and costs incurred to patients.

The trial is registered at ANZCTR (ACTRN12624001451594). ANZCTR is a primary registry that meets the requirements of the ICMJE and is listed on the ICTRP Registry Network.

The study protocol has been approved by the University of New South Wales Human Research Ethics Committee (HREC) (iRECS6645) and complies with the National Health and Medical Research Council ethical guidelines. Participating practices and each GP will provide written, informed consent. All patients being screened will provide electronic informed consent. Results of the study will be disseminated through various forums, including peer-reviewed publications and presentation at national and international conferences. Following the study, participating practices will be provided with a summary of the findings of the study, together with a full copy of any publications and a plain language statement for participants, which will be made available in the practice reception area.

The COmmunity HEalth System InnovatiON (COHESION) project (2016–2019) was a 4-year collaboration between research teams from Mozambique, Nepal, Peru and Switzerland. It conducted formative health system research using tracer chronic conditions, non-communicable diseases (diabetes and hypertension) and one neglected tropical disease per country (schistosomiasis in Mozambique, leprosy in Nepal and neurocysticercosis in Peru).

Findings guided the co-creation of interventions to improve diagnosis and management through a participatory approach with communities, primary healthcare workers and regional health authorities.

As a continuation of this effort, the research team initiated the COHESION Implementation project (COHESION-I) with two objectives: (1) implement and evaluate the context-specific co-created interventions in Mozambique, Nepal and Peru (Component 1) and (2) adapt the COHESION approach to India, a country that did not benefit from a formative phase previously (Component 2). This protocol manuscript focuses on Component 1.

A mixed-methods, pre–post quasi-experimental design will be used, including quantitative, qualitative, economic and process evaluations. Each country will have three arms: (1) co-created and co-designed interventions; (2) only co-designed intervention and (3) the usual care arm. Data will be collected longitudinally over 18 months to assess the effect of the interventions. The main outcomes include patient satisfaction (Patient Satisfaction Questionnaire Short Form), health system responsiveness (WHO responsiveness domains) and quality of life (EuroQol 5 dimensions 5 levels). The qualitative evaluation will explore how satisfaction is perceived among service users with chronic conditions and healthcare workers. Other outcomes per type of evaluation will be considered such as perceived value of health services, cost estimation and acceptability of the intervention components, among others.

Approvals were obtained from Ethics Committees of Universidad Peruana Cayetano Heredia (Peru), Universidade Eduardo Mondale (Mozambique) and Nepal Health Research Council (Nepal). Results will be disseminated through peer-reviewed publications and scientific conferences.

NCT06989502.

Monitoring 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.

Consecutive 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.

The 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.

CTRI/2024/06/068838.