Fall PreventionAPN-FITNCT06617806
Advanced Practice Nurses for Fall Incidence PrevenTion in Very Old Robust Adults
A study testing Follow-up by the Advanced Practice Nurse in people with Fall Prevention and Autonomy of Older People, run by Nantes University Hospital at 1 site in France.
Trial summary
APN-FIT is a hybrid type 1 clinical trial comparing the effect of an APN delivered fall prevention programme with standard care in non-frail patients. All participants will receive a full geriatric assessment at enrolment and, on a voluntary basis, physical activity programmes during the 12-month period. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Fall Prevention, Autonomy of Older People, Frail Elderly
- What is being tested?
- Follow-up by the Advanced Practice Nurse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2024to 31 Oct 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 80 or over;
- Vigorous according to the " Clinical Frailty Scale " (scores 1, 2, 3) ;
- Having a referring primary care physician working in pairs with the local Advanced Practice Nurse;
- affiliated to a Health Care Plan
- Informed and having signed consent to participate in the research.
Who cannot join
- Under guardianship or trusteeship;
- Unable to travel to the primary care office or unable to follow the adapted physical activity program;
- Poor understanding of French.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cédric RAT, MD - Pr contact
France1 site, 1 recruiting
- Recruiting
CHU Nantes
Nantes, Loire-Atlantique, 44
Laure De DECKER, MD PhD, 0240083333 ext. +33, laure.dedecker@chu-nantes.fr
About this study
Official title: Advanced Practice Nurses for Fall Incidence PrevenTion in Robust Very Old Adults: Protocol for the APN-FIT Hybrid Randomized Controlled Trial
APN-FIT is a hybrid type 1 clinical trial comparing the effect of an APN delivered fall prevention programme with standard care in non-frail patients. All participants will receive a full geriatric assessment at enrolment and, on a voluntary basis, physical activity programmes during the 12-month period. Falls occurring during the study will be recorded at 2, 4, 6, 8, 10 and 12 months after enrolment. An ancillary study will specifically examine implementation outcomes of the tested intervention.
Read the detailed description
Introduction and objectives
The 2020s witnessed the emergence of Advanced Practice Nurses (APN) as a novel paramedical profession in France, bolstering the primary care workforce and service landscape. These nurses are expected to reinforce various dimensions of primary care, including therapeutic education, prevention, screening, and clinical and therapeutic follow-up of patients. There is a need regarding the evaluation of APN led intervention in the prevention of falls in non-frail elderly.
APN-FIT is a pragmatic, hybrid type 1, multicenter, randomized open-label superiority trial addressing this question. The study population will include primary care patients aged over 80 years old, classified as vigorous (according to Clinical Frailty Scale) and able to follow a tailored intervention program. The study will be conducted in seven local primary-care centers in the Pays de la Loire region of France.
Preselection will be done by GPs and APNs, recruitment will be done by APNs in their local caregiving center. APNs will perform a complete comprehensive geriatric assessment (CGA) for each participant at enrolment, followed by a detailed analysis of the resulting data and the emission of a panel of recommendation. A 1:1 randomization of participants will be conducted using a random block size ranging from 4 to 6, stratified by APN.
All participants will benefit from a CGA at inclusion and M12. A home-based physical activity program, over a period of 7 weeks, with twice-weekly sessions (45 min each), will also be proposed to all participants. In the intervention group, each APN will schedule follow-ups at 1, 3, 6, 9, and 12 months post-inclusion. Each participant will be contacted every two months (i.e 2,4,6,8,10 onths) by the research assistant or nurse for data collection on falls and secondary outcome criteria in a blinded approach. All participants will be assessed for a new CGA at M12 by a research nurse.
Quantitative main analysis
The primary outcome is the number of falls recorded at 12 months.
Secondary outcomes include:
- Number of falls and severe falls as defined by the World Fall Guidelines at each time point
- Level of independence, evaluated by Katz' index and Lawton's instrumental activities of daily living
- Level of healthcare utilization
- Level of emergency care service utilization
- Frailty measured with the Clinical Frailty Scale and ICOPE monitor score
- Cognitive performance
- Mental health status
- Nutritional status
- Quality of life evaluated by EQ-5D-5L
A cost-utility analysis (CUA) will be conducted, from a collective perspective and one-year time horizon.
Ancillary study of implementation
An ancillary study will be conducted to facilitate a deeper understanding of the efficacy elements observed in the main study. Its purpose is to determine optimal implementation conditions for practical deployment in the field. The data collection for this ancillary study is primarily opportunistic, coinciding with the data collection necessary to address the main study's primary objective. The indicators described by Proctor and colleagues will be used for the evaluation : acceptability, relevance, adoption, efficiency, feasibility, fidelity, scope and sustainability.
The implementation will undergo evaluation at patient level and healthcare provider level. Individual and group interviews will be conducted. Discourse saturation will be sought. The survey of professionals will occur during initial observations and focus groups. The data analysis will draw from the sociology of professions. A sequential thematic analysis of discourse and a visual examination of non-verbal communication elements and social interactions will be used to capture factors that facilitate or limit program implementation.
- Being tested
- Follow-up by the Advanced Practice Nurse
- Keywords
- Fall prevention, Aging, Frailty - robustness, Advanced practice nurses, Very old adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up by the Advanced Practice NurseOther
At each follow-up (FU), the recommendations of an APN may include :
- Referral to a specialized memory assessment in case of cognitive impairment
- Psychological FU in the event that APN detects any mood complaints
- Ophthalmological and/or ear, nose, and throat consultation if any auditory or visual difficulties is observed
- Compression stockings use if orthostatic hypotension is present
- Nutritional counseling, with particular emphasis on the intake of protein, in combination with long-term assessment of weight
- Supplementation with vitamin D and calcium based to prevent osteoporosis in older adults, especially those at risk of recurrent falls
- Proposal of a standardized and personalized physical activity program
- Evaluation of medication therapies, especially antipsychotics, blood pressure medication or broad anticholinergics. The STOPPFall tool will be also proposed and coordinated by APN in accordance with the patient's physician
- A comprehensive social evaluative approach
| Study group | Role | What they receive |
|---|---|---|
| Advanced Practice Nurse Follow-up | Experimental | The patient is followed-up by his Advanced Practice Nurse and General Practitionner
The Advanced Practice Nurse (APN) will schedule follow-ups at 1, 3, 6, 9, and 12 months post-inclusion, leveraging their full range of skills and scope of practice. At each follow-up, the APN will ensure that the initial recommendations are being followed and will adjust them according to the patient's progress. The APN will work closely with all actors involved, including the adapted physical activity professional, attending physician, pharmacist, care assistant, and nurse.
As for all participants, two CGAs will be performed at inclusion by APN and at M12 by the research nurse.
An Adapted Physical Activity (APA) program will also be included. Participants will receive an APA falls prevention program consisting of 14 sessions, each lasting 45 minutes, conducted by a professional APA teacher in the comfort of their own home. Receives: Other: Follow-up by the Advanced Practice Nurse |
| Usual Care | No intervention | Short version: The patient is handled by his General Practitionner as usual after the first CGA Extended version: As for all participants, two CGAs will be performed at inclusion by APN and at M12 by the research nurse. An Adapted Physical Activity (APA) program will also be included. Participants will receive an APA falls prevention program consisting of 14 sessions, each lasting 45 minutes, conducted by a professional APA teacher in the comfort of their own home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls in each group
An unexpected event in which an individual comes to rest on the ground, floor, or lower level
Measured: 12 months after enrollment in the study
Secondary outcomes (8)
Number of falls and severe falls at each time point
Severe falls is defined by the World Fall Guidelines (2022) as "fall with injuries that are severe enough to require a consultation with a physician; result in the person lying on the ground without capacity to get up for at least one hour; prompt a visit to the emergency room (ER); associated with loss of consciousness"
Measured: 2-4-6-8-10 and 12 months after inclusion
Level of independance
Activities of daily living (Katz index) and Lawton's instrumental activities of daily livng
Measured: 12 months after inclusion
Level of healthcare utilization
Number of consultations, utilization of dental, ophthalmological, and ear-nose-throat care during the follow-up period
Measured: 12 months after inclusion
Level of emergency care service utilization
Number of stays in an emergency hospitalization unit during the follow-up period.
Measured: 12 months after inclusion
Cognitive performance and mental status
MMSE (mini mental state examination) and FAB (frontal assessment battery) score for cognition. Mini-geriatric depression scale for mental health
Measured: 12 months after inclusion
Quality of Life
Evaluated by EQ-5D-5L scale
Measured: 12 months after inclusion
Frailty and physical performance
Frailty measured by the Clinical Frailty scale and Integrated Care for Older People (ICOPE) Monitor score Physical performance assessed with Timed Up and Go test and the Short Physical Performance Battery
Measured: 12 months after inclusion
Number of participants with malnutrition
Body mass index, weight loss and Mini Nutritional Assessment
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start15 Oct 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fall PreventionStudies 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
- Model description
- Pragmatic randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pôle Fédératif de Soins Primaires (https://dmg.univ-nantes.fr/c/pole-federatif), Université de Nantes
- Responsible party
- Sponsor
- Investigators
- Laure DE DECKER, MD - Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617806
- Sponsor's protocol ID
- RC23_0018
- Other IDs
- Mécénat AXA 2022
- Acronym
- APN-FIT
- Status last verified
- Nov 2024
- First submitted
- 26 Sep 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A minimal dataset that allows to interpret, replicate and build upon the findings will be available from the corresponding author on reasonable request.
Publications
Huet J, Rat C, Renaux C, Mayol S, Costanza S, Riche VP, Deschamps T, Caillet P, de Decker L. Advanced practice nurses for fall incidence prevention in robust very old adults: protocol for the APN-FIT hybrid randomized controlled trial. BMC Geriatr. 2025 Nov 22;26(1):68. doi: 10.1186/s12877-025-06781-0.
PubMed 41275104
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Practice Nurses for Fall Incidence PrevenTion in Robust Very Old Adults: Protocol for the APN-FIT Hybrid Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06617806
- Acronym / sponsor ID
- APN-FIT / RC23_0018
- Keywords
- Fall prevention, Aging, Frailty - robustness, Advanced practice nurses, Very old adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Pôle Fédératif de Soins Primaires (https://dmg.univ-nantes.fr/c/pole-federatif), Université de Nantes
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 27 Sep 2024 (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.
APN-FIT is a hybrid type 1 clinical trial comparing the effect of an APN delivered fall prevention programme with standard care in non-frail patients. All participants will receive a full geriatric assessment at enrolment and, on a voluntary basis, physical activity programmes during the 12-month period. Falls occurring during the study will be recorded at 2, 4, 6, 8, 10 and 12 months after enrolment. An ancillary study will specifically examine implementation outcomes of the tested intervention.
Detailed description
Introduction and objectives
The 2020s witnessed the emergence of Advanced Practice Nurses (APN) as a novel paramedical profession in France, bolstering the primary care workforce and service landscape. These nurses are expected to reinforce various dimensions of primary care, including therapeutic education, prevention, screening, and clinical and therapeutic follow-up of patients. There is a need regarding the evaluation of APN led intervention in the prevention of falls in non-frail elderly.
APN-FIT is a pragmatic, hybrid type 1, multicenter, randomized open-label superiority trial addressing this question. The study population will include primary care patients aged over 80 years old, classified as vigorous (according to Clinical Frailty Scale) and able to follow a tailored intervention program. The study will be conducted in seven local primary-care centers in the Pays de la Loire region of France.
Preselection will be done by GPs and APNs, recruitment will be done by APNs in their local caregiving center. APNs will perform a complete comprehensive geriatric assessment (CGA) for each participant at enrolment, followed by a detailed analysis of the resulting data and the emission of a panel of recommendation. A 1:1 randomization of participants will be conducted using a random block size ranging from 4 to 6, stratified by APN.
All participants will benefit from a CGA at inclusion and M12. A home-based physical activity program, over a period of 7 weeks, with twice-weekly sessions (45 min each), will also be proposed to all participants. In the intervention group, each APN will schedule follow-ups at 1, 3, 6, 9, and 12 months post-inclusion. Each participant will be contacted every two months (i.e 2,4,6,8,10 onths) by the research assistant or nurse for data collection on falls and secondary outcome criteria in a blinded approach. All participants will be assessed for a new CGA at M12 by a research nurse.
Quantitative main analysis
The primary outcome is the number of falls recorded at 12 months.
Secondary outcomes include:
- Number of falls and severe falls as defined by the World Fall Guidelines at each time point
- Level of independence, evaluated by Katz' index and Lawton's instrumental activities of daily living
- Level of healthcare utilization
- Level of emergency care service utilization
- Frailty measured with the Clinical Frailty Scale and ICOPE monitor score
- Cognitive performance
- Mental health status
- Nutritional status
- Quality of life evaluated by EQ-5D-5L
A cost-utility analysis (CUA) will be conducted, from a collective perspective and one-year time horizon.
Ancillary study of implementation
An ancillary study will be conducted to facilitate a deeper understanding of the efficacy elements observed in the main study. Its purpose is to determine optimal implementation conditions for practical deployment in the field. The data collection for this ancillary study is primarily opportunistic, coinciding with the data collection necessary to address the main study's primary objective. The indicators described by Proctor and colleagues will be used for the evaluation : acceptability, relevance, adoption, efficiency, feasibility, fidelity, scope and sustainability.
The implementation will undergo evaluation at patient level and healthcare provider level. Individual and group interviews will be conducted. Discourse saturation will be sought. The survey of professionals will occur during initial observations and focus groups. The data analysis will draw from the sociology of professions. A sequential thematic analysis of discourse and a visual examination of non-verbal communication elements and social interactions will be used to capture factors that facilitate or limit program implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Advanced Practice Nurse Follow-up | Experimental | Other: Follow-up by the Advanced Practice NurseThe patient is followed-up by his Advanced Practice Nurse and General Practitionner The Advanced Practice Nurse (APN) will schedule follow-ups at 1, 3, 6, 9, and 12 months post-inclusion, leveraging their full range of skills and scope of practice. At each follow-up, the APN will ensure that the initial recommendations are being followed and will adjust them according to the patient's progress. The APN will work closely with all actors involved, including the adapted physical activity professional, attending physician, pharmacist, care assistant, and nurse. As for all participants, two CGAs will be performed at inclusion by APN and at M12 by the research nurse. An Adapted Physical Activity (APA) program will also be included. Participants will receive an APA falls prevention program consisting of 14 sessions, each lasting 45 minutes, conducted by a professional APA teacher in the comfort of their own home. |
| Usual Care | No intervention | –Short version: The patient is handled by his General Practitionner as usual after the first CGA Extended version: As for all participants, two CGAs will be performed at inclusion by APN and at M12 by the research nurse. An Adapted Physical Activity (APA) program will also be included. Participants will receive an APA falls prevention program consisting of 14 sessions, each lasting 45 minutes, conducted by a professional APA teacher in the comfort of their own home. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged 80 or over;
- Vigorous according to the " Clinical Frailty Scale " (scores 1, 2, 3) ;
- Having a referring primary care physician working in pairs with the local Advanced Practice Nurse;
- affiliated to a Health Care Plan
- Informed and having signed consent to participate in the research.
Key exclusion criteria (3 listed)
- Under guardianship or trusteeship;
- Unable to travel to the primary care office or unable to follow the adapted physical activity program;
- Poor understanding of French.
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 |
|---|---|---|
| Follow-up by the Advanced Practice NurseAt each follow-up (FU), the recommendations of an APN may include : * Referral to a specialized memory assessment in case of cognitive impairment * Psychological FU in the event that APN detects any mood complaints * Ophthalmological and/or ear, nose, and throat consultation if any auditory or visual difficulties is observed * Compression stockings use if orthostatic hypotension is present * Nutritional counseling, with particular emphasis on the intake of protein, in combination with long-term assessment of weight * Supplementation with vitamin D and calcium based to prevent osteoporosis in older adults, especially those at risk of recurrent falls * Proposal of a standardized and personalized physical activity program * Evaluation of medication therapies, especially antipsychotics, blood pressure medication or broad anticholinergics. The STOPPFall tool will be also proposed and coordinated by APN in accordance with the patient's physician * A comprehensive social evaluative approach | Other | Advanced Practice Nurse Follow-up |
Primary outcome
Number of falls in each group
Time frame: 12 months after enrollment in the study
An unexpected event in which an individual comes to rest on the ground, floor, or lower level
8 secondary outcomes
Number of falls and severe falls at each time point
Time frame: 2-4-6-8-10 and 12 months after inclusion
Level of independance
Time frame: 12 months after inclusion
Level of healthcare utilization
Time frame: 12 months after inclusion
Level of emergency care service utilization
Time frame: 12 months after inclusion
Cognitive performance and mental status
Time frame: 12 months after inclusion
Quality of Life
Time frame: 12 months after inclusion
Frailty and physical performance
Time frame: 12 months after inclusion
Number of participants with malnutrition
Time frame: 12 months after inclusion
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 15 Nov 2024.
- Derived from this study: PubMed 41275104Huet J, Rat C, Renaux C, Mayol S, Costanza S, Riche VP, Deschamps T, Caillet P, de Decker L. Advanced practice nurses for fall incidence prevention in robust very old adults: protocol for the APN-FIT hybrid randomized controlled trial. BMC Geriatr. 2025 Nov 22;26(1):68. doi: 10.1186/s12877-025-06781-0.
- Individual participant dataSharing planned: Yes. A minimal dataset that allows to interpret, replicate and build upon the findings will be available from the corresponding author on reasonable request.
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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.
Cédric RAT, MD - Pr contact
Laure DE DECKER, MD - Pr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up by the Advanced Practice Nurse in people with Fall Prevention and Autonomy of Older People, run by Nantes University Hospital at 1 site in France.
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 5 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. 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 France. 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?
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 Laure DE DECKER, MD - Pr (02.40.08.79.20 ext. +332, laure.dedecker@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of falls in each group (time frame: 12 months after enrollment in the study). 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 NCT06617806, which also lists 1 linked publication.
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 15 Nov 2024.