NURsing-led FRAILty Prevention and Care (NUR-FRAIL)

NURsing-led FRAILty Prevention and Care: a Quasi-experimental Study

The goal of this quasi-experimental study is to learn if a nurse-led care program can help prevent or manage frailty in older adults living in the community.

The study focuses on people aged 65 years and older who have at least one chronic condition, show early signs of frailty, and have difficulty with self-care.

The main questions it aims to answer are:

• Does the nurse-led NUR-FRAIL program improve participants' ability to care for their chronic conditions after six months?
• Does the program improve quality of life and reduce health-related difficulties?
• Does the program lower emergency department visits and hospital stays over one year?

Researchers will compare participants who receive the NUR-FRAIL program with participants who receive usual care to see if the program leads to better self-care, better quality of life, and less use of hospital services.

Participants will:

• Meet with a Family and Community Nurse for health and frailty assessments at the start of the study, after three months, and after six months
• Complete short questionnaires about self-care, daily functioning, and quality of life
• Receive either usual care or a three-month nurse-led program that includes personalized education, goal setting, lifestyle advice, and support for managing chronic conditions
• Allow researchers to collect information about emergency visits and hospital stays for up to twelve months

Some participants in the nurse-led group will also be invited to take part in an interview to share their experience with the program.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Conditions
• Intervention / Treatment: Behavioral: NUR-FRAIL

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Longhini; Phone Number: 3405322936; Email: jessica.longhini@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Presence of at least one positive indicator on the SUNFRAIL questionnaire
• Age 65 years or older
• At least one chronic condition
• Poor self-care abilities, defined as a score of 0, 1, or 2 on at least two items of the Self-Care of Chronic Illness Inventory

Exclusion criteria:

- Not able to provide information on questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention NUR-FRAIL; Participants in this arm receive the NUR-FRAIL nurse-led program in addition to usual care. The program is delivered by Family and Community Nurses over a three-month period and includes at least four structured contacts (clinic visits, home visits, and/or telephone contacts). The intervention starts with a comprehensive frailty assessment based on the World Health Organization Integrated Care for Older People (ICOPE) framework, followed by personalized education and shared goal setting. Key components include: Multidimensional frailty assessment (mobility, nutrition, cognition, mood, vision, hearing, social support, caregiver burden, and urinary continence) Identification of participant priorities and care needs Individualized education to support self-care and functional ability Lifestyle guidance (physical activity, nutrition, hydration, fall prevention, medication adherence, sleep, mental well-being, and social participation) Shared SMART goal setting Use of evidence-base	Behavioral: NUR-FRAIL; Participants in this arm receive the NUR-FRAIL nurse-led program in addition to usual care. The program is delivered by Family and Community Nurses over a three-month period and includes at least four structured contacts (clinic visits, home visits, and/or telephone contacts). The intervention starts with a comprehensive frailty assessment based on the World Health Organization Integrated Care for Older People (ICOPE) framework, followed by personalized education and shared goal setting. Key components include: Multidimensional frailty assessment (mobility, nutrition, cognition, mood, vision, hearing, social support, caregiver burden, and urinary continence) Identification of participant priorities and care needs Individualized education to support self-care and functional ability Lifestyle guidance (physical activity, nutrition, hydration, fall prevention, medication adherence, sleep, mental well-being, and social participation) Shared SMART goal setting Use of evidence-based
No Intervention: Control; Participants in this arm receive usual care provided by Family and Community Nursing Services. Usual care may include routine nursing visits, clinical monitoring, and referrals according to local practice but does not include the structured NUR-FRAIL intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-care maintenance was assessed using the Self-Care of Chronic Illness Inventory questionnaire (minimum score = 0, maximum score = 100), where higher scores indicate better self-care.	Self-care maintenance was assessed using the Self-Care of Chronic Illness Inventory (minimum score = 0, maximum score = 100), where higher scores indicate better self-care.	SIX MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Self-perceived patient complexity was assessed using the INTERMED questionnaire (minimum score = 0, maximum score = 60), where higher scores indicate greater patient complexity.	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.	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.	three and six months
Number of emergency department access by patient	Number of emergency department access by patient	six and 12 months
Number of hospitalization by patient	Number of hospitalization by patient	six and 12 months

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: frailty; primary care; nursing; chronic conditions; community nursing
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Frailty; Chronic Disease
• Other Study ID Numbers: NUR-FRAIL 33CET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No