Multimodal Nursing Care for Stroke Caregivers: Protocol for a Randomized Controlled Trial

Background Stroke is one of the most devastating neurological conditions worldwide, leaving survivors dependent on family members for long-term care. Family caregivers of stroke survivors in India frequently experience significant physical, emotional, social, and financial burdens, particularly during the hospital-to-home transition, with little structured support available. To address this gap, the Multimodal Approach to Nursing Care (MANC) module was developed as a structured nurse-led intervention combining caregiver education, medical device management training, psychosocial support, and progressive muscle relaxation techniques. Objective This study aims to develop and validate the MANC module and evaluate its effectiveness in reducing caregiver burden and stress, and improving quality of life and caregiving competence among family caregivers of patients with cerebrovascular accident (CVA), compared with routine caregiving practices. Methods This prospective randomized controlled trial will be conducted at the Acharya Vinoba Bhave Rural Hospital in Sawangi, Wardha, India. Ninety family caregivers of patients with CVA will be randomly allocated into experimental (n=45) and control (n=45) groups. Allocation concealment will be maintained through sequentially numbered, opaque, sealed envelopes. Given the single-researcher study design, complete blinding is not feasible. All outcome measures are standardized self-reported instruments, minimizing assessment bias. Outcomes include caregiver burden, stress, quality of life, caregiving competence, and patient health outcomes, assessed at baseline and postintervention. Data will be analyzed using appropriate parametric and nonparametric tests, with significance set at P <.05. Results Ethical approval was obtained from the Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research (Deemed University) in December 2024 (IEC number DMIHER(DU)/IEC/2024/53), and the trial was registered with the Clinical Trials Registry–India (CTRI/2025/07/090412). Data collection commenced in February 2026, and recruitment is currently ongoing. Results are expected to be submitted for publication by the end of 2026. Conclusions The MANC intervention is anticipated to reduce caregiver burden and stress while improving quality of life and caregiving competence among family caregivers of stroke survivors, potentially serving as a replicable model for poststroke transitional care across Indian tertiary care settings.