This protocol uses a 3-stage mixed methods design guided by the 11-step adaptation framework proposed by Escoffery [18]. This structured approach ensures a systematic process, from community needs assessment to intervention implementation and evaluation, as illustrated in Figure 1.

This feasibility study prioritizes estimation precision over hypothesis testing. Therefore, we adopt a precision-based rationale for 10 to 15 dyads. For feasibility proportions (eg, 3-month retention and weekly adherence), a sample of 15 dyads yields an approximate 95% CI half-width of about +22 or –22 percentage points when the true rate is around 75% (and about +27 or –27 percentage points for n=10), which is sufficient to judge performance against feasibility thresholds. For continuous outcomes, a sample of 10 to 15 dyads provides approximately 24% to 19% relative precision for the SD (RSE(σ)≈√[1/(2(n−1))]), which is adequate to inform sample-size calculations for a subsequent trial. Regarding safety, if no adverse events (AEs) are observed, the “rule of three” places the upper 95% confidence bound on per-dyad AE risk at approximately 3/n (ie, no more than 20% for n=15), providing an acceptable early-phase safety screen. Taken together and consistent with previous feasibility studies of Namaste Care and related dementia interventions, a sample of 10 to 15 dyads is sufficient and appropriate to estimate key feasibility metrics and guide the design of a larger study.

Training will be led by the principal investigator (a Namaste Care regional champion) with the support of community nurses [26]. Sessions will be delivered on weekends across 2 consecutive weeks, approximately 2 hours per day, supplemented by online modules to enhance access and optional individualized follow-ups for emerging challenges. The curriculum will cover the program’s history and core practices; practical use of the NCHP checklist and NCHP bag; assessment of pain, mood, and agitation; and illustrative activities (eg, memory books and dementia-friendly gardening). A concise NCHP manual will be provided before training and will be used as an ongoing reference. Following training, caregivers will apply skills at home with ongoing support, and a process evaluation 1 week after training will assess engagement and inform iterative updates to the manual and training [26].

This feasibility study will use a 1-group pretest-posttest design. We acknowledge potential threats to internal validity (eg, history and regression to the mean), noting that this design is standard in feasibility research preceding more rigorous trials.

The study was approved by the Nanjing University of Chinese Medicine Ethics Committee in April 2025 (2025-NZY-4‐01) and was registered at the Chinese Clinical Trial Registry on April 18, 2025 (ChiCTR2500101042). The study protocol adhered to the principles of the Declaration of Helsinki [43] and Good Clinical Practice guidelines. All participants provided written informed consent before participation.

Given the nature of the population involved (people with dementia), special consideration was given to obtaining informed consent. Although dementia leads to cognitive decline, it does not automatically imply a loss of decision-making capacity. People with dementia may retain the ability to understand simplified consent forms and express their preferences, especially in the early stages. The study respected the residual autonomy of participants, and information was adapted to accommodate their cognitive abilities. Consent was continuously monitored throughout the study. In cases where a participant could not provide valid consent, a legally designated representative was involved, but the participant’s willingness to participate was always considered through a “double consent” approach. Participants had the right to withdraw at any time without any consequences. As compensation for their time and effort, each participating dyad received a 100 RMB (US $14.07) gift package upon completion of assessment. This was clarified during the consent process to avoid undue influence.

AEs include skin breakdown, falls, or activity-related discomfort, defined as any unfavorable and unintended sign, symptom, or event occurring during participation. SAEs are defined as events that result in death, life-threatening conditions, hospitalization or its prolongation, significant disability, or other medically significant conditions. Caregivers will be trained to recognize and document AEs and to report them immediately to the NCHP coordinator. The research team will assess severity and relatedness, determine whether an event is intervention-related, and take appropriate action. SAEs will be reported to the principal investigator and the ethics committee within 24 hours; nonserious AEs will be documented within 72 hours and summarized in periodic safety reports. Immediate first aid will be provided when necessary, and participants will be referred to community health services if required. If repeated or severe intervention-related AEs occur, the intervention may be paused, or the participant withdrawn; study-level suspension will be considered if predefined safety thresholds are exceeded. An independent safety officer will conduct an independent safety review at regular intervals to oversee AE logs and corrective actions.

Personal data collected during the trial will be handled and stored in accordance with applicable data protection laws, including the General Data Protection Regulation and the Personal Information Protection Law of China. Data will be pseudonymized upon study completion, and access to identifiable data will be restricted to authorized study personnel. All data and related documentation will be securely stored in compliance with regulatory requirements, and the use of study data will be controlled by the principal investigator.

This protocol describes the systematic cultural adaptation and feasibility evaluation of the NCHP for Chinese families. By tailoring this EBI to local cultural values and practical realities, we aim to deliver a feasible and acceptable program that enhances QoL for people with dementia and reduces caregiver burden.

The use of a structured adaptation framework provides a transparent, replicable roadmap for modifying EBIs to new contexts and may inform similar work in other LMICs. Integrating culturally relevant elements (eg, traditional Chinese medicine–informed practices and locally meaningful activities) is expected to support engagement and acceptability. The feedback-driven, iterative process is designed to keep the intervention person-centered while maintaining fidelity to the core components.

Findings from this feasibility study will inform the design of future larger studies. Feasibility estimates (recruitment yield, 3-month retention, session adherence, and variance of primary outcomes) will inform sample-size calculations and site-level targets; fidelity and workload data will help determine training dose, supervision cadence, and acceptable fidelity thresholds; and process metrics (eg, time on task, missed visits, and data-capture completeness) will guide whether to standardize phone-based or brief digital assessments at scale.

Although this study is expected to provide valuable insights, several limitations must be considered. First, the one-group pretest-posttest design limits our ability to draw causal inferences, as observed changes may reflect history, regression to the mean, or the Hawthorne effect. Second, the small sample size and single-site design will constrain generalizability. Additionally, measurement bias is possible (eg, caregiver-reported outcomes), and blinding will not be feasible. To mitigate these issues, we will prespecify outcomes and assessment time points (T0, T1, and T2), monitor fidelity and AEs, integrate qualitative data for triangulation, and place primary emphasis on effect sizes with 95% CIs rather than hypothesis testing. Subsequent studies will adopt comparative designs (eg, waitlist, cluster randomized, or stepped-wedge trials) to strengthen causal inference and external validity.

We anticipate risks related to caregiver adherence, participant attrition, and resource constraints (eg, time, staffing, and materials), as well as potential intervention contamination within community settings. To address these risks, we plan to (1) provide scheduled check-ins and just-in-time coaching to sustain adherence; (2) use practical supports (brief manuals and NCHP bags) and flexible scheduling to reduce burden; (3) monitor fidelity with brief checklists and remedial feedback; (4) prospectively document protocol deviations and reasons for missing data; and (5) apply analysis plans suitable for small feasibility samples (eg, parsimonious linear mixed-effects models under a missing-at-random assumption, descriptive P values, and sensitivity analyses). If adherence or retention falls below predefined feasibility thresholds (eg, ≥3 days per week, with ≥4 hours on ≥1 day, and ≥75% retention), we will implement prespecified adjustments, such as increasing remote support frequency, simplifying activity menus, or modifying data-collection modes (eg, phone-based or brief digital questionnaires), while documenting all changes in the audit trail. These contingencies will inform modifications for a subsequent adequately powered multisite evaluation.

The findings of this study will be crucial for informing future research. Specifically, data on feasibility (recruitment and retention rates), acceptability (caregiver feedback), and preliminary effect sizes will provide foundational insights for the design of larger-scale, multicenter, randomized controlled trials. Such a trial would offer definitive evidence of the effectiveness and cost-effectiveness of the adapted NCHP, paving the way for its broader dissemination and integration into the Chinese community-based long-term care system.

This culturally adapted NCHP holds significant potential in addressing the unique challenges faced by Chinese family caregivers of people with dementia, offering a holistic, person-centered intervention that aligns with local caregiving practices. The outcomes of this study will contribute valuable knowledge on the feasibility and acceptability of the program, setting the stage for future studies to confirm its effects. These efforts will ultimately strengthen the evidence base for nonpharmacological dementia interventions in China and other resource-limited settings.