JMIR Research Protocols

Implementing Effective Infection Prevention and Control in Residential Aged Care Through Communities of Practice: Protocol for a Before-and-After Study (IMMERSE-2)

2026-11-06T14:15:10-05:00

Background: In Australian residential aged care, infection prevention and control (IPC) Lead nurses (IPC Leads) are a key part of the IPC program. IPC Leads are often the main IPC contacts and provide support to staff to improve IPC and resident outcomes. To enhance their competence and self-efficacy, IPC Leads need to engage in ongoing role development. Connecting with other IPC Leads, learning together, and sharing ideas and resources could also be beneficial. Communities of practice (CoPs) have been shown to improve self-efficacy and job satisfaction by fostering belonging, peer learning, and problem-solving. Drawing on social learning theory, CoPs encourage learning with and from one another to explore and iteratively develop practice. This study draws on the CoP literature and builds on our previous pilot of a CoP for IPC Leads in 1 state of Australia, which found promising impacts on confidence and practice change. Objective: This study will evaluate CoPs for IPC Leads working in Australian residential aged care. Primarily, the study will assess changes in IPC Leads’ self-efficacy. It will also explore job satisfaction and IPC practice improvement and assess the acceptability and feasibility of CoPs. Methods: We are conducting a before-and-after study using multimethods. We will recruit IPC Leads from across Australia to participate in the CoPs. The CoPs will be implemented over 12 months, with online sessions held monthly for 30 to 60 minutes each. Baseline and 12-month follow-up surveys of IPC Leads’ self-efficacy and job satisfaction and audits of IPC practice will be conducted. At the 12-month follow-up, surveys and interviews with IPC Leads will be used to assess the acceptability and feasibility of the CoPs and to explore case examples of IPC Leads facilitating practice change. Researcher notes and costing data collected will be used to further evaluate the feasibility and fidelity of the CoPs. Quantitative data will be summarized descriptively, and an ordinal mixed-effects model with a logit link will be used to assess change in self-efficacy. Interview data will be analyzed using an inductive approach, followed by a deductive approach, based on the Framework Method. Results: This project was funded in October 2024 and commenced in February 2025. As of April 30, 2026, 97 potential participants had registered their interest in participating, but no participants had been enrolled (ie, consented to participate). Recruitment of IPC Leads began in March 2026. The CoPs are expected to commence in June to July 2026. Data collection will commence in May 2026, and data analysis is expected to be completed by January 2028. Study results are expected to be published in 2028. Conclusions: The findings will create new research knowledge in the field of CoPs and knowledge translation in the aged care sector and inform the sustainability and potential for future scale-up of this collaborative social learning approach. International Registered Report Identifier (IRRID): DERR1-10.2196/97683

Assessing the Effectiveness, Engagement, and Acceptability of a Smartwatch Healthy Lifestyle Intervention for Cognitive Enhancement in Healthy Adults: Mixed Methods Electroencephalography Protocol

2026-11-06T14:00:26-05:00

Background: Wearable technologies are rapidly transforming the health care landscape by enabling the tracking of real-time physiological and behavioral data used in healthy lifestyle interventions. Despite their widespread adoption in the consumer market, scientific validation of their impact on the brain remains limited, and factors influencing effects on cognition and adherence are not fully understood. This gap is critical, as consumers, health care providers, and researchers depend on these data to unlock the potential of wearables for cognitive support. Objective: We aim to assess the effectiveness, engagement, and acceptability of a commercially available smartwatch healthy lifestyle intervention on cognitive enhancement in healthy adults, using a convergent parallel mixed methods design. We seek to provide a comprehensive, replicable methodological framework to evaluate wearable technology interventions targeting cognitive enhancement in healthy adults. Methods: Healthy adults aged 18 to 40 years with a sedentary lifestyle (N=72) interested in participating in a healthy lifestyle intervention will be recruited in the Vancouver Metropolitan Area, BC, Canada. Participants will be randomly assigned into an intervention group using an Apple Watch or a control group following standard physical activity guidelines without an Apple Watch for a period of 4 weeks. Effectiveness will be evaluated through (1) cognitive function (primary outcome)—executive function, specifically inhibitory control, via electroencephalogram-based event-related potentials (N2/P3) during a go/no-go task; (2) resting-state brain activity via electroencephalogram spectral power; (3) behavioral performance (reaction time and accuracy); (4) perceived health (36-item Short Form Health Survey); and (5) qualitative analysis of factors affecting the intervention’s effectiveness. Engagement will be assessed through goal completion metrics and qualitative analysis of barriers, facilitators, and usage patterns. Acceptability will be assessed through System Usability Scale scores and qualitative analysis of factors affecting usability, satisfaction, and user preferences. This design integrates assessments before, during, and after intervention. Qualitative assessments will include weekly check-ins and semistructured interviews to obtain a comprehensive understanding of factors influencing the effectiveness, engagement, and acceptability of the intervention. Exploratory outcomes include descriptions of possible interactions between the 3 constructs and comparison of smartwatch-tracked vs self-reported goal completion. Results: The study received funding from the AGE-WELL Network Centres of Excellence (April 2020-March 2023) and was approved by the Simon Fraser University Research Ethics Board. Enrollment for the study is ongoing. As of October 2026, data have been collected from 48 participants and are currently being processed and analyzed. The first results are expected to be published in 2027. Conclusions: This study outlines a foundational framework for evaluating the effectiveness, engagement, and acceptability of wearable health interventions targeting cognitive enhancement in healthy adults. Furthermore, our mixed methods approach with randomized controlled comparison is expected to inform the design and development of effective, engaging, and friendly wearable brain health technologies. International Registered Report Identifier (IRRID): DERR1-10.2196/81490

Efficacy of a Smartphone-Based Virtual Patient in Increasing Clinical Competence Among Primary Health Care Providers: Protocol for a Cluster Randomized Controlled Trial

2026-11-06T13:45:18-05:00

Background: Virtual patients (VPs) are considered cost-effective and convenient tools for clinical training. The research team developed a smartphone-based VP tailored to the needs of primary health care physicians in rural China. The VP demonstrated high levels of feasibility and acceptability in this group in a previous study. Objective: The proposed cluster randomized controlled trial (RCT) will compare the efficacy of clinical training delivered via a smartphone-based VP in increasing diagnosis and treatment competence among primary health care providers in rural China as compared to a waitlist control group. Methods: This is a partially blinded (outcome assessors and data analysts) and parallel-group cluster RCT conducted in Lintao county, China. All 18 township health centers in Lintao will be randomized evenly into either the intervention or the waitlist control group. The target sample size is 150 physicians per group. Physicians in the intervention group will receive clinical training delivered via the smartphone-based VP. They will be required to complete the diagnosis and treatment plan of 2 conditions randomly assigned by the VP within a 1-month intervention period. The VP will provide detailed feedback on their procedures. The intervention group can also access 9 other conditions in the VP and receive detailed feedback during the intervention period. Participants in the control group will not have access to any clinical training delivered via the VP during the 1-month intervention period. They will gain full access to the VP system after completion of the outcome assessment at T1 (1 month after baseline [T0]). The primary outcome is the score representing overall diagnosis and treatment competence. To measure this outcome, participants will be invited to complete the diagnosis and treatment plan of a condition randomly assigned by the smartphone-based VP at both T0 and T1. Intention-to-treat analysis will be performed. Results: Study recruitment started on August 1, 2026. By August 15, 2026, a total of 18 township health centers had been randomly assigned to either the intervention (9 centers) or control (9 centers) group. A total of 216 physicians from these centers completed baseline assessment; 56% (121/216) were randomly assigned to the intervention group, and 44% (95/216) were assigned to the control group. Recruitment will be completed by the end of November 2026. The follow-up assessment at T1 will start in September 2026. Data collection is expected to be concluded in January 2027. Conclusions: The findings will extend the application of smartphone-based VPs in medical training. If the smartphone-based VP is proven effective in increasing diagnosis and treatment competence among primary health care physicians in rural China, it will provide a feasible and effective alternative training tool to address the existing service gaps. Trial Registration: Chinese Clinical Trial Registry ChiCTR2600127364; https://tinyurl.com/rbkzxxnj International Registered Report Identifier (IRRID): DERR1-10.2196/106849

Optimizing a Tool to Track Effectiveness and Responsiveness for Family Peer Support (Project OTTERS for Family Peer): Protocol for Mechanism Pathway Development and Measure Validation

2026-11-06T13:00:03-05:00

Background: Family peers (FPs) have lived experience of parenting a child with mental health needs and specialized training to support other caregivers. They provide informational, emotional, affirmational, and instrumental support and are reimbursable by Medicaid in many states. While there have been positive results of FP support in randomized trials, there is little understanding of the mechanisms through which FP support improves caregiver and child outcomes. While observational coding is considered the gold standard for measuring psychosocial interventions, it has not been acceptable to FPs. This makes it necessary to explore other strategies for measuring intervention delivery. Objective: This study will (1) identify common FP intervention components across a range of FP programs and models, (2) delineate potential causal mechanisms for FP success related to child and caregiver outcomes, and (3) develop a pragmatic measure to capture use of these common FP intervention components to support larger-scale testing. Methods: This study will use intervention mapping to examine one-to-one FP support for caregivers of children aged 5-17 years in outpatient clinic, community, and home-based settings. We will survey 50 FPs and 50 caregivers across FP models. We will purposively select 48 participants to complete qualitative interviews (32 FPs and 16 caregivers). We will identify common FP components and their associated mechanisms and organize them in a logic model (aim 2). We will then create a corresponding tool to capture use of these components (aim 2), which we will validate with 200 FPs (aim 3). Of these FPs, 40 will complete up to 2 role plays of an FP encounter alongside the tool, which we will compare with observational coding. Another subset of 40 FPs and caregivers will be asked to complete a parallel self-report tool to report on the content of a selected session. Results: The study was funded in September 2025 by the National Institute of Mental Health (NIMH). Recruitment for aim 1 began in August 2026, with 4 participants enrolled in August 2026. The project will end in August 2029. We will submit deidentified study data collected in aims 1 and 3 to the NIMH Data Archive for participants who consent to data sharing. Conclusions: This study will advance our understanding of the common intervention components of FP support and associated mechanisms of change that go on to impact caregivers and children. This study will also result in a tool to measure this content across a range of outpatient programs and models. Results will inform a larger experimental trial to test the identified mechanisms of effective FP support.

Effects of Lactobacillus crispatus–Containing Probiotics and Metformin on Insulin Resistance, Inflammation, and Gut Microbiome in Polycystic Ovary Syndrome: Protocol for an Open-Label Randomized Controlled Trial

2026-11-05T16:30:23-05:00

Background: Polycystic ovary syndrome (PCOS) affects 9% to 12% of reproductive-age women worldwide, with higher prevalence reported in India. Its pathophysiology involves insulin resistance, hyperandrogenism, and chronic low-grade inflammation, increasingly linked to gut dysbiosis and lipopolysaccharide-driven toll-like receptor 4 signaling. Elevated calprotectin and suppressed acylated ghrelin (AGH) reflect this inflammatory-metabolic disruption. While metformin remains standard therapy, it does not address underlying gut dysbiosis. , with its antibacterial and immunomodulatory properties, is a promising but untested gut-targeted adjunct. This trial evaluates whether combining metformin with supplementation improves metabolic and inflammatory outcomes beyond either therapy alone. Objective: This study aims to compare probiotic, metformin, and combination therapy for reducing insulin resistance in PCOS over 12 weeks and assess their effects on gut barrier integrity, microbiome composition, hyperandrogenemia, glycemic control, and clinical outcomes. Methods: This open-label randomized, hospital-based trial at the All India Institute of Medical Sciences, Bhubaneswar, will assess the effects of probiotic and/or metformin therapy in women aged 18 to 40 years diagnosed with PCOS per Rotterdam criteria. A total of 135 participants will be randomized equally into 3 groups: probiotics only, metformin only, and combination therapy. The 3-month intervention includes metformin (1000 mg per day) and a specified –containing probiotic (2 capsules per day). The primary outcome is the change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). Key secondary outcomes include changes in serum and fecal calprotectin, AGH, total testosterone, and fecal microbiome profile. Results: Participant recruitment began in January 2026. As of August 30, 2026, 26 of the planned 135 participants had been enrolled. Enrollment and data collection are projected to conclude by December 2026; statistical analysis will begin after database lock, with study completion anticipated by June 2027 and publication targeted for mid- to late 2027. Conclusions: This trial will provide critical, mechanistic evidence on whether the targeted action of can work additively with metformin to heal the intestinal mucosal barrier, arrest systemic endotoxemia, and rescue disrupted gut-brain-endocrine signaling. By validating this novel metabolic-inflammatory regimen against localized (calprotectin) and systemic (AGH and HOMA-IR) end points, this study intends to establish a highly integrated, microbiome-targeted therapeutic strategy capable of optimizing long-term metabolic and reproductive health outcomes in women with PCOS. Trial Registration: Clinical Trials Registry - India CTRI/2025/09/094113; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTQxMDcz&Enc=&userName= International Registered Report Identifier (IRRID): DERR1-10.2196/102121

Evaluation of the Clinical Utility of Circulating Tumor DNA in the Management of Patients With Nonmetastatic Head and Neck Cancer: Protocol for a Prospective Bicentric Study (CIRVAD)

2026-11-05T16:30:23-05:00

Background: Human papillomavirus (HPV)–negative head and neck cancers, often linked to tobacco and alcohol exposure, have a poor prognosis and high recurrence rates. Circulating tumor DNA (ctDNA) is a promising biomarker for detecting minimal residual disease and monitoring treatment response. Recent studies show that ctDNA can detect recurrence earlier than clinical or radiological methods. Prospective trials are needed to validate its clinical utility. Objective: The primary objective is to assess postoperative ctDNA as a predictor of 28-month progression-free survival. Secondary objectives include evaluating ctDNA levels before and after treatment as predictors of recurrence, studying ctDNA dynamics during follow-up in relation to survival, and exploring their association with tumor characteristics and surgical outcomes. Methods: This prospective, bicentric study evaluates ctDNA in patients undergoing surgery for head and neck squamous cell carcinoma. Plasma ctDNA concentrations will be measured quantitatively in ng/mL before and 1 to 2 weeks after surgery, with or without adjuvant radiotherapy or chemotherapy. Progression-free survival is defined as the time from surgery to disease progression or death, and recurrence-free survival as the time to clinically confirmed recurrence. Overall and disease-specific survival will also be assessed. Changes in ctDNA levels over follow-up and clinical characteristics will be compared between patients with and without progression at 28 months. Absolute and relative variations in ctDNA preoperatively and postoperatively will be described, and surgical quality will be evaluated according to resection margins (R0, R1, R2). Results: As of August 2026, study preparation, including protocol development and methodological validation, has been completed. The study is currently entering the implementation phase, with regulatory procedures, funding applications, and site initiation activities underway. No participants have been recruited at the time of manuscript submission, as recruitment has not yet begun. Recruitment is expected to start following regulatory approval and funding acquisition. The funding status remains pending as of August 2026, with funding applications underway. Participant recruitment and data collection are projected to take approximately 24 months, followed by a 28-month follow-up period. Data analysis has not yet started and will be conducted after completion of the follow-up period. The first study results are therefore expected to become available after the completion of data collection and follow-up, although a precise publication timeline (season/year) cannot yet be determined. Conclusions: This study aims to provide key data on the potential of ctDNA to detect early recurrence in HPV-negative cancers and could inform personalized patient monitoring and management. International Registered Report Identifier (IRRID): PRR1-10.2196/89973

Terminology for “Elder Orphans” and Aging Well: Protocol for a Scoping Review

2026-11-05T16:30:23-05:00

Background: Elder orphans have been described as a growing vulnerable population of isolated older adults with limited social and caregiving support. There is a lack of consistency in the terminology and definitions of elder orphans. This lack of consistency impedes research and implementation of services for elder orphans, who are predisposed to isolation, loneliness, unmet care needs, and a decline in health outcomes. It is imperative for elder orphans to plan for their health and well-being as they age in the community. Objective: The objectives of the scoping review are (1) to document the definitions and settings surrounding terms used to describe elder orphans, (2) to explore the determinants of isolation and loneliness in elder orphans, and (3) to understand the barriers to and facilitators of planning to age well in elder orphans. Methods: This review follows the JBI methodology for scoping reviews and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. The search strategy was first developed and piloted in the Scopus database on October 16, 2025, to identify initial articles on the topic. The following databases were searched: Scopus, MEDLINE ALL (Ovid), CINAHL Complete (EBSCOhost), APA PsycINFO (EBSCOhost), Social Work Abstracts (EBSCOhost), Web of Science (Clarivate), Sociological Abstracts (ProQuest), Sociology Database (ProQuest), and Applied Social Sciences Index & Abstracts (ASSIA; ProQuest). Gray literature was searched using Google (incognito) and ClinicalTrials.gov. Only literature in English was considered due to staff constraints. Two reviewers will screen and extract data independently using piloted screening and data extraction tools. Descriptive analysis will include narrative summaries, tables, and charts and deductive thematic analysis using appropriate frameworks. Results: This protocol has been registered on the Open Science Framework. As of October 2026, the final search and abstract citation screening has been completed. We expect screening, data extraction, and synthesis to be completed by February 2027, with the manuscript of the scoping review submitted thereafter. Conclusions: This review explores both peer-reviewed and gray literature using rigorous and reproducible methods. It will support researchers in streamlining future work on elder orphans and will identify directions for future research and services for elder orphans. Trial Registration: OSF Registries osf.io/x8536; https://osf.io/x8536 International Registered Report Identifier (IRRID): DERR1-10.2196/107175

Real-Time Monitoring and Predictive Analytics for Preventing and Reducing Restrictive Practices in Health and Social Care: Protocol for a Scoping Review

2026-11-05T16:15:18-05:00

Background: Restrictive practices, including restraint and seclusion, are used across aged care, mental health, and disability support settings to manage behaviors of concern. These practices are associated with substantial ethical, psychological, and physical harms. Digital health technologies, including real-time monitoring systems and AI-enabled predictive analytics, are increasingly used to detect early behavioral escalation. However, detection or prediction alone does not reduce restrictive practices. It remains unclear how these technologies are translated into care actions, decision-making, and measurable outcomes in real-world settings. Objective: This scoping review aims to identify and map evidence on real-time monitoring, predictive analytics, and related digital technologies used to prevent or reduce restrictive practices in health and social care. The review will examine the technologies and contexts studied; how technology outputs are translated into care responses and workflows; and the implementation, outcomes, governance, and ethical considerations reported. Methods: The review will be conducted in accordance with Joanna Briggs Institute methodology and will be reported using the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). Librarian-assisted searches were conducted in MEDLINE, CINAHL Ultimate, PsycINFO, Scopus, and IEEE Xplore on March 11, 2026. The executed database search strategies were not modified after Open Science Framework registration. Reference lists of included studies and relevant reviews will be screened using citation chasing. Eligible English-language sources will be those that examine digital technologies linked to care responses intended to reduce restrictive practices or to reported restrictive-practice outcomes. Two reviewers will independently screen records and chart all included sources. Standard scoping-review mapping categories will be used to describe the evidence landscape. The Implementation Research Logic Model will inform analysis of explicitly reported implementation determinants, strategies, mechanisms, and outcomes. Results: Electronic database searches were completed on March 11, 2026. Protocol version 5.0 was registered with the Open Science Framework on March 22, 2026. Title and abstract screening had not commenced at the time of registration. The review is expected to be completed by July 2027. Conclusions: By clarifying how digital detection and prediction technologies are translated into care actions, and the conditions under which restrictive practice–related outcomes are reported, this review will support safer, more ethical, and more implementable digital health approaches. International Registered Report Identifier (IRRID): DERR1-10.2196/98754

Effectiveness of Smartphone-Based Versus Community-Based Otago Exercise Programs for Fall Risk Reduction in Community-Dwelling Older Adults: Protocol for a Randomized Controlled Trial

2026-11-05T16:00:30-05:00

Background: The Otago Exercise Program (OEP), traditionally delivered at home by a physical therapist, is an evidence-based intervention proven to reduce falls and fall-related injuries in older adults. Despite its effectiveness, widespread adoption has been limited by the personnel and resource demands required for program delivery. Exploring alternative delivery methods, including remote platforms and community-based programs, may help overcome implementation barriers and expand access to this program. Objective: This study aims to evaluate (1) the effectiveness of 2 delivery modes of the OEP, a remotely delivered, smartphone-based program, and an in-person, community-based program, and (2) participant experiences, feasibility, and acceptability across both delivery formats. Methods: Thirty-six adults aged 55 years or older, classified as being at intermediate or high risk for falls according to the World Falls Guidelines, will be enrolled in this study. Eligible participants will be randomly assigned to one of two intervention groups: (1) a remotely delivered, smartphone-based OEP, or (2) an in-person, community-based OEP. Participants in the community-based group will attend sessions at a senior center, whereas those in the smartphone-based group will complete the program at home via the Improve (Vipul Lugade) smartphone app. Both groups will receive individualized 60-minute training sessions twice a week for 8 weeks, delivered by certified trainers under the supervision of physical therapists. The 16-session program will include progressive balance, mobility, and strengthening exercises consistent with the OEP. The primary outcome is self-selected gait speed. Secondary outcomes include injurious falls, fall risk assessed using the Physiological Profile Assessment, Timed Up and Go, 30-Second Chair Stand, 4-Stage Balance Test, and 4-Square Step Test, as well as measures of feasibility, acceptability, usability, and health-related quality of life. Outcomes will be assessed at baseline and postintervention by investigators blinded to group allocation. In addition, gait speed will be assessed weekly throughout the 8-week intervention using the Improve app to monitor changes over time. Trainers will be blinded to outcome data, including baseline and interim assessment results. Results: The study received funding in February 2026, and enrollment began in the same month. As of May 2026, 16 participants have been enrolled. Data collection is expected to be completed in December 2026, with findings anticipated for dissemination by the middle of 2027. Conclusions: This is the first study to use a smartphone to deliver OEP and to directly compare remote- and community-based delivery platforms. Findings may support broader adoption and implementation of this evidence-based fall prevention program by reducing participation barriers and expanding access for older adults, particularly in remote and underserved areas. Trial Registration: ClinicalTrials.gov NCT07433153; https://clinicaltrials.gov/study/NCT07433153 International Registered Report Identifier (IRRID): DERR1-10.2196/102920

Nurse-Led Sepsis Scoring System for Adult Febrile Neutropenia: Protocol for a Two-Phase Clinical Prediction Model Study With Remote Patient Monitoring

2026-11-05T14:00:30-05:00

Background: Adults with hematological malignancies who develop febrile neutropenia (FN) face elevated risks of sepsis, intensive care admission, and treatment interruptions. Early sepsis detection is challenging, as classical clinical signs are often attenuated or delayed in this population. Current risk stratification tools demonstrate limitations when applied to adults with FN. A tailored, nurse-led scoring system integrating clinical, laboratory, and physiological predictors may enhance early sepsis identification. Objective: This 2-phase study aims to develop and internally validate a nurse-led sepsis risk score for adults with FN in phase I and to temporally validate its performance in phase II. The new score will be compared to the MASCC risk index, CISNE, NEWS2_ and qSOFA at FN onset . The secondary objectives include evaluating associations between risk groups and remote patient monitoring alerts within 24 hours of FN onset, interrater agreement, and bedside feasibility. Methods: The study is being conducted in the hematology and bone marrow transplantation department of a tertiary care hospital in Bengaluru, India. Phase I uses a nested matched case-control design within a retrospective cohort of approximately 140 patients with FN. We will analyze clinical, laboratory, and physiological predictors measured at FN onset using multivariable conditional logistic regression, with internal validation via bootstrapping. In Phase II, which utilizes a prospective temporal validation cohort, bedside nurses will calculate the proposed score at FN onset alongside the MASCC, CISNE, NEWS2, and qSOFA scores A substudy will include additional nurses scoring independently to assess interrater agreement and feasibility. Two blinded reviewers will adjudicate phase I outcomes within 14 days of FN onset, while assessors blinded to all scores will adjudicate phase II outcomes within the same time frame. The primary outcome is sepsis within 14 days of FN onset. Phase II evaluates discrimination, calibration, and comparative diagnostic performance. Results: We obtained ethics approval in April 2025, and the study was registered in June 2025 (CTRI/2025/06/088290). The initial phase I derivation was completed in November 2025, using sepsis within 14 days of FN onset as the primary outcome. A protocol amendment in September 2026 harmonized the outcome window to 14 days, prompting rederivation of the model and superseding the initial analysis. Phase II commenced in December 2025. As of September 2026, enrollment and data collection were ongoing, with study completion anticipated in December 2026. Main results are expected in 2027. Conclusions: This protocol evaluates an FN-specific, nurse-led sepsis score integrating clinical and laboratory predictors with contactless physiological measurements. We will examine remote patient monitoring alerts as secondary markers of clinical instability. Validation findings will establish the score’s predictive performance and inform future implementation studies. Trial Registration: Clinical Trials Registry–India (CTRI) CTRI/2025/06/088290; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTMzMDky&Enc=&userName International Registered Report Identifier (IRRID): DERR1-10.2196/107468