Chronic ConditionsNUR-FRAILNCT07435064
NURsing-led FRAILty Prevention and Care
A study testing NUR-FRAIL in people with Chronic Conditions, run by University of Padova.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Conditions
- What is being tested?
- NUR-FRAIL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Not able to provide information on questionnaires
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Chronic Conditions
- Being tested
- NUR-FRAIL
- Keywords
- frailty, chronic conditions, nursing, primary care, community nursing
- Medical subject headings
- Chronic Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUR-FRAILBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: three and six months
Number of emergency department access by patient
Number of emergency department access by patient
Measured: six and 12 months
Number of hospitalization by patient
Number of hospitalization by patient
Measured: six and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Longhini, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435064
- Sponsor's protocol ID
- NUR-FRAIL 33CET
- Acronym
- NUR-FRAIL
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NURsing-led FRAILty Prevention and Care: a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07435064
- Acronym / sponsor ID
- NUR-FRAIL / NUR-FRAIL 33CET
- Conditions
- Chronic Conditions
- Keywords
- frailty, chronic conditions, nursing, primary care, community nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention NUR-FRAIL | Experimental | Behavioral: NUR-FRAILParticipants 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 |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Not able to provide information on questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUR-FRAILParticipants 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 | Behavioural | Intervention NUR-FRAIL |
Primary outcome
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.
Time frame: SIX MONTHS
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing NUR-FRAIL in people with Chronic Conditions, run by University of Padova.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Longhini (3405322936, jessica.longhini@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: SIX MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.