Chronic DiseaseNURSE-LEDFOCNCT07922993
Effectiveness of a Nurse-Led Transitional Care Model Based on the Fundamentals of Care Framework
A study testing Community Hospital in people with Chronic Disease and Transition Care, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
This study aims to find out whether nurse-led transitional care can help older adults with chronic health conditions recover safely after leaving the hospital. It also examines whether this approach can lower the risk of returning to the hospital within 30 days. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Disease, Transition Care, Hospital Readmission
- What is being tested?
- Community Hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged 60 years or older.
- Diagnosis of at least one chronic condition (e.g., chronic obstructive pulmonary disease, diabetes, heart disease, heart failure, musculoskeletal disorders, or hypertension).
- Ability to understand the study information and provide informed consent.
- Planned discharge from an acute medical ward to their own home.
Who cannot join
- Participants requiring daily assistance from a family member or informal caregiver to perform activities of daily living.
- Inability to understand the study information or provide informed consent.
- Planned discharge to other healthcare or residential care settings, such as nursing homes or rehabilitation centers.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to find out whether nurse-led transitional care can help older adults with chronic health conditions recover safely after leaving the hospital. It also examines whether this approach can lower the risk of returning to the hospital within 30 days.
The study includes 652 adults aged 60 years or older with at least one long-term health condition. All participants were receiving care in medical wards at an Italian university hospital and were preparing to return home.
Read more
Participants were randomly assigned to one of two groups:
Nurse-led transitional care: Participants received additional care in a nurse-led unit before returning home. Nurses assessed their health and daily needs, provided personalized care and education, and helped plan a safe return home. This approach followed the Fundamentals of Care Framework, which focuses on meeting people's physical, emotional, and social care needs.
Usual care: Participants received standard hospital care and returned directly home after discharge, without the additional nurse-led transitional care program.
Researchers assessed participants' ability to perform daily activities, memory and thinking skills, risk of falls, and risk of developing pressure injuries (skin damage caused by prolonged pressure). They also checked whether participants returned to the hospital unexpectedly within 30 days.
By comparing the two groups, the study aims to understand whether additional nurse-led care can support recovery, improve independence, and help older adults remain safely at home after hospitalization.
- Conditions
- Chronic Disease, Transition Care, Hospital Readmission
- Being tested
- Community Hospital, Usual Care
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community HospitalOther
The intervention was based on the Fundamentals of Care Framework and included comprehensive nursing assessment, individualized care planning, daily clinical monitoring, patient education, and coordinated discharge planning. Nurses supported participants' physical, emotional, and social care needs, promoted self-care skills, and coordinated care with community health services. The maximum length of stay was 14 days, followed by a 30-day follow-up after discharge.
Usual CareOther
Participants received standard hospital care and returned directly home after discharge, without the additional nurse-led transitional care program.
| Study group | Role | What they receive |
|---|---|---|
| Community Hospital | Experimental | Participants assigned to this group received nurse-led transitional care in a Community Hospital before returning home. The intervention was based on the Fundamentals of Care Framework and included comprehensive nursing assessment, individualized care planning, daily clinical monitoring, patient education, and coordinated discharge planning. Nurses supported participants' physical, emotional, and social care needs, promoted self-care skills, and coordinated care with community health services. The maximum length of stay was 14 days, followed by a 30-day follow-up after discharge. Receives: Other: Community Hospital |
| Usual Care - Direct Discharge Home | Active comparator | Participants assigned to this group received usual care in acute medical wards and were discharged directly home after clinical stabilization. They received standard discharge instructions and routine care, without transfer to a Community Hospital or participation in the structured nurse-led transitional care program. Community health services were provided when indicated according to usual clinical practice. Participants were followed up 30 days after discharge. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned Hospital Readmission Within 30 Days
The proportion of participants experiencing at least one unplanned hospital readmission within 30 days after final hospital discharge. Readmissions to any hospital in the Lazio region were identified using regional administrative hospital databases. The outcome was compared between the nurse-led transitional care group and the usual care group.
Measured: Within 30 days after final hospital discharge
Secondary outcomes (4)
Change in Functional Independence Assessed by the Barthel Index
Functional independence was assessed using the Barthel Index, which measures the ability to perform 10 basic activities of daily living, including feeding, bathing, dressing, mobility, and personal hygiene. Total scores range from 0 to 100, with higher scores indicating greater independence. Changes from baseline were compared between the two study groups.
Measured: Baseline and 30 days after final hospital discharge.
Change in Pressure Injury Risk Assessed by the Braden Scale
The risk of developing pressure injuries was assessed using the Braden Scale, which evaluates six areas: sensory perception, skin moisture, physical activity, mobility, nutrition, and friction or shear. Total scores range from 6 to 23, with lower scores indicating a higher risk of pressure injuries. Changes from baseline were compared between the two study groups.
Measured: Baseline and 30 days after final hospital discharge.
Change in Cognitive Status Assessed by the Short Portable Mental Status Questionnaire
Cognitive status was assessed using the Short Portable Mental Status Questionnaire (SPMSQ), a 10-item instrument evaluating orientation, memory, and basic cognitive functioning. According to the scoring system used in this study, total scores range from 0 to 11, with higher scores indicating better cognitive functioning. Changes from baseline were compared between the two study groups.
Measured: Baseline and 30 days after final hospital discharge.
Change in Fall Risk Assessed by the Modified Morse Fall Scale
Fall risk was assessed using a modified version of the Morse Fall Scale consisting of six dichotomous items. Total scores range from 0 to 6, with higher scores indicating greater fall risk. Scores of 0-2 indicate low risk, 3-4 moderate risk, and 5-6 high risk. Changes from baseline were compared between the two study groups.
Measured: Baseline and 30 days after final hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Sep 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacopo Fiorini, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922993
- Sponsor's protocol ID
- 669
- Other IDs
- 2.26.3
- Acronym
- NURSE-LEDFOC
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study may be made available to qualified researchers upon reasonable request to the corresponding author. Data sharing will be subject to approval of the research team and compliance with applicable ethical and data protection requirements. No directly identifiable participant information will be shared.
Publications
Saari H, Lonnroos E, Kautiainen H, Kokko S, Ryynanen OP, Mantyselka P. Incidence of short-term community hospital stays and clinical profiles of patients: the Finnish Community Hospital Cohort Study. Scand J Prim Health Care. 2024 Mar;42(1):82-90. doi: 10.1080/02813432.2023.2291671. Epub 2024 Feb 7.
PubMed 38095573Sun M, Qian Y, Liu L, Wang J, Zhuansun M, Xu T, Rosa RD. Transition of care from hospital to home for older people with chronic diseases: a qualitative study of older patients' and health care providers' perspectives. Front Public Health. 2023 Apr 27;11:1128885. doi: 10.3389/fpubh.2023.1128885. eCollection 2023.
PubMed 37181713Recio-Saucedo A, Dall'Ora C, Maruotti A, Ball J, Briggs J, Meredith P, Redfern OC, Kovacs C, Prytherch D, Smith GB, Griffiths P. What impact does nursing care left undone have on patient outcomes? Review of the literature. J Clin Nurs. 2018 Jun;27(11-12):2248-2259. doi: 10.1111/jocn.14058. Epub 2017 Oct 16.
PubMed 28859254
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nurse-Led Transitional Care Model Based on the Fundamentals of Care Framework
- ClinicalTrials.gov ID
- NCT07922993
- Acronym / sponsor ID
- NURSE-LEDFOC / 669
- Conditions
- Chronic Disease, Transition Care, Hospital Readmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 6 Nov 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.
This study aims to find out whether nurse-led transitional care can help older adults with chronic health conditions recover safely after leaving the hospital. It also examines whether this approach can lower the risk of returning to the hospital within 30 days.
The study includes 652 adults aged 60 years or older with at least one long-term health condition. All participants were receiving care in medical wards at an Italian university hospital and were preparing to return home.
Participants were randomly assigned to one of two groups:
Nurse-led transitional care: Participants received additional care in a nurse-led unit before returning home. Nurses assessed their health and daily needs, provided personalized care and education, and helped plan a safe return home. This approach followed the Fundamentals of Care Framework, which focuses on meeting people's physical, emotional, and social care needs.
Usual care: Participants received standard hospital care and returned directly home after discharge, without the additional nurse-led transitional care program.
Researchers assessed participants' ability to perform daily activities, memory and thinking skills, risk of falls, and risk of developing pressure injuries (skin damage caused by prolonged pressure). They also checked whether participants returned to the hospital unexpectedly within 30 days.
By comparing the two groups, the study aims to understand whether additional nurse-led care can support recovery, improve independence, and help older adults remain safely at home after hospitalization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Hospital | Experimental | Other: Community HospitalParticipants assigned to this group received nurse-led transitional care in a Community Hospital before returning home. The intervention was based on the Fundamentals of Care Framework and included comprehensive nursing assessment, individualized care planning, daily clinical monitoring, patient education, and coordinated discharge planning. Nurses supported participants' physical, emotional, and social care needs, promoted self-care skills, and coordinated care with community health services. The maximum length of stay was 14 days, followed by a 30-day follow-up after discharge. |
| Usual Care - Direct Discharge Home | Active comparator | Other: Usual CareParticipants assigned to this group received usual care in acute medical wards and were discharged directly home after clinical stabilization. They received standard discharge instructions and routine care, without transfer to a Community Hospital or participation in the structured nurse-led transitional care program. Community health services were provided when indicated according to usual clinical practice. Participants were followed up 30 days after discharge. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 60 years or older.
- Diagnosis of at least one chronic condition (e.g., chronic obstructive pulmonary disease, diabetes, heart disease, heart failure, musculoskeletal disorders, or hypertension).
- Ability to understand the study information and provide informed consent.
- Planned discharge from an acute medical ward to their own home.
Key exclusion criteria (3 listed)
- Participants requiring daily assistance from a family member or informal caregiver to perform activities of daily living.
- Inability to understand the study information or provide informed consent.
- Planned discharge to other healthcare or residential care settings, such as nursing homes or rehabilitation centers.
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 |
|---|---|---|
| Community HospitalThe intervention was based on the Fundamentals of Care Framework and included comprehensive nursing assessment, individualized care planning, daily clinical monitoring, patient education, and coordinated discharge planning. Nurses supported participants' physical, emotional, and social care needs, promoted self-care skills, and coordinated care with community health services. The maximum length of stay was 14 days, followed by a 30-day follow-up after discharge. | Other | Community Hospital |
| Usual CareParticipants received standard hospital care and returned directly home after discharge, without the additional nurse-led transitional care program. | Other | Usual Care - Direct Discharge Home |
Primary outcome
Unplanned Hospital Readmission Within 30 Days
Time frame: Within 30 days after final hospital discharge
The proportion of participants experiencing at least one unplanned hospital readmission within 30 days after final hospital discharge. Readmissions to any hospital in the Lazio region were identified using regional administrative hospital databases. The outcome was compared between the nurse-led transitional care group and the usual care group.
4 secondary outcomes
Change in Functional Independence Assessed by the Barthel Index
Time frame: Baseline and 30 days after final hospital discharge.
Change in Pressure Injury Risk Assessed by the Braden Scale
Time frame: Baseline and 30 days after final hospital discharge.
Change in Cognitive Status Assessed by the Short Portable Mental Status Questionnaire
Time frame: Baseline and 30 days after final hospital discharge.
Change in Fall Risk Assessed by the Modified Morse Fall Scale
Time frame: Baseline and 30 days after final hospital discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 38095573Saari H, Lonnroos E, Kautiainen H, Kokko S, Ryynanen OP, Mantyselka P. Incidence of short-term community hospital stays and clinical profiles of patients: the Finnish Community Hospital Cohort Study. Scand J Prim Health Care. 2024 Mar;42(1):82-90. doi: 10.1080/02813432.2023.2291671. Epub 2024 Feb 7.
- Background: PubMed 37181713Sun M, Qian Y, Liu L, Wang J, Zhuansun M, Xu T, Rosa RD. Transition of care from hospital to home for older people with chronic diseases: a qualitative study of older patients' and health care providers' perspectives. Front Public Health. 2023 Apr 27;11:1128885. doi: 10.3389/fpubh.2023.1128885. eCollection 2023.
- Background: PubMed 28859254Recio-Saucedo A, Dall'Ora C, Maruotti A, Ball J, Briggs J, Meredith P, Redfern OC, Kovacs C, Prytherch D, Smith GB, Griffiths P. What impact does nursing care left undone have on patient outcomes? Review of the literature. J Clin Nurs. 2018 Jun;27(11-12):2248-2259. doi: 10.1111/jocn.14058. Epub 2017 Oct 16.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study may be made available to qualified researchers upon reasonable request to the corresponding author. Data sharing will be subject to approval of the research team and compliance with applicable ethical and data protection requirements. No directly identifiable participant information will be shared.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Hospital in people with Chronic Disease and Transition Care, run by University of Rome Tor Vergata at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned Hospital Readmission Within 30 Days (time frame: Within 30 days after final hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07922993, which also lists 3 linked publications.
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 6 Nov 2026.