NURsing-led FRAILty Prevention and Care

NUR-FRAIL (NURsing-led FRAILty Prevention and Care) is a multicenter quasi-experimental controlled study designed to evaluate the effectiveness of a structured nurse-led intervention for the prevention and management of frailty in community-dwelling older adults. Study Design and Setting This is a 12-month multicenter quasi-experimental study conducted within Family and Community Nursing Services in four districts of ULSS 7 Pedemontana (Italy). Allocation to intervention or control group is determined at the service level based on organizational feasibility to ensure comparable care contexts.

All participants undergo standardized assessments at baseline, three months, and six months. Healthcare utilization data are collected at six and twelve months.

Intervention Participants in the intervention group receive the NUR-FRAIL program over three months, delivered by trained Family and Community Nurses through in-person (clinic or home) and/or telephone contacts. The intervention includes at least four structured contacts.

The program integrates the WHO ICOPE framework and consists of:

Structured multidimensional assessment of frailty, including evaluation of cognitive function, mobility, nutritional status, vision, hearing, depressive symptoms, social support, caregiver burden, and urinary incontinence.

Identification of participant-prioritized needs, using open-ended assessment to capture individual concerns and goals.

Individualized therapeutic education pathway, including:

Functional ability enhancement Chronic disease self-care support Lifestyle modification (physical activity, nutrition, hydration, sleep, fall prevention, vaccination, medication adherence, cardiovascular risk management, cognitive stimulation, social participation) SMART goal setting (Specific, Measurable, Achievable, Realistic, Time-bound).

Evidence-based communication strategies, including:

Teach-back method Motivational interviewing Shared decision-making using the SHERPA model Family-centered approaches when appropriate Participants receive tailored educational materials developed in alignment with ICOPE recommendations.

Nurses delivering the intervention receive structured training sessions to ensure fidelity to the model.

Participants in the control group receive usual care provided by the Family and Community Nursing Services.

Outcomes The primary outcome is self-care maintenance at six months, measured using the Self-Care of Chronic Illness Inventory.

Secondary outcomes include:

Self-care monitoring and self-care management Self-reported health complexity Health-related quality of life Emergency department visits Hospitalizations related to chronic conditions or frailty

Data Collection and Analysis Quantitative data include socio-demographic and clinical variables, questionnaire scores, and healthcare utilization records. Statistical analyses will include descriptive statistics, between-group comparisons, and regression models to adjust for potential confounders. Statistical significance will be set at p \< 0.05.

Qualitative data will be collected through semi-structured interviews with a purposive subsample of participants in the intervention group. Interviews will explore satisfaction, perceived benefits, and areas for improvement. Transcripts will undergo content analysis performed independently by trained researchers to ensure methodological rigor.

Sample Size and Ethics The study is powered to detect a clinically meaningful difference in self-care maintenance between groups. Accounting for expected attrition, approximately 200 participants will be enrolled. All participants will provide written informed consent. Data will be managed in compliance with European data protection regulations (GDPR).

• Self-care monitoring was assessed using the Self-Care of Chronic Illness Inventory questionnaire (minimum score = 0, maximum score = 100), where higher scores indicate better self-care. [Time frame: three and six months]
• Self-care management was assessed using the Self-Care of Chronic Illness Inventory questionnaire (minimum score = 0, maximum score = 100), where higher scores indicate better self-care. [Time frame: three and six months]
• Self-perceived patient complexity was assessed using the INTERMED questionnaire (minimum score = 0, maximum score = 60), where higher scores indicate greater patient complexity. [Time frame: three and six months]
• Quality of life was assessed using the 12-Item Short Form Health Survey (SF-12) (minimum score = 0, maximum score = 100), where higher scores indicate better quality of life. [Time frame: three and six months]
• Number of emergency department access by patient [Time frame: six and 12 months]
• Number of hospitalization by patient [Time frame: six and 12 months]