NURsing-led FRAILty Prevention and Care
ConditionChronic Conditions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Padova
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
NUR-FRAIL
BehavioralParticipants 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
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Intervention NUR-FRAILExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
SIX MONTHSSecondary outcomes
1
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.
Time frame
three and six months2
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.
Time frame
three and six months3
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.
Time frame
three and six months4
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.
Time frame
three and six monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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