NURsing-led FRAILty Prevention and Care

NCT07435064 | Not Yet Recruiting

• 1 other identifier: NUR-FRAIL 33CET
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Conditions

Keywords

frailty; chronic conditions; nursing; primary care; community nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

  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.

  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.

  three and six months

• Number of emergency department access by patient

  six and 12 months

Study Arms (2)

Intervention NUR-FRAIL

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

NUR-FRAIL BEHAVIORAL

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

Intervention NUR-FRAIL

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Not able to provide information on questionnaires

Sponsors & Collaborators

• University of Padova: lead

MeSH Terms

Conditions

Chronic Disease; Frailty

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jessica Longhini

CONTACT

3405322936; jessica.longhini@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share