Advanced Practice Nurses for Fall Incidence PrevenTion in Very Old Robust Adults
APN-FIT
2 other identifiers
interventional
386
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedStudy Start
First participant enrolled
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
November 15, 2024
November 1, 2024
3 years
September 26, 2024
November 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of falls in each group
An unexpected event in which an individual comes to rest on the ground, floor, or lower level
12 months after enrollment in the study
Secondary Outcomes (8)
Number of falls and severe falls at each time point
2-4-6-8-10 and 12 months after inclusion
Level of independance
12 months after inclusion
Level of healthcare utilization
12 months after inclusion
Level of emergency care service utilization
12 months after inclusion
Cognitive performance and mental status
12 months after inclusion
- +3 more secondary outcomes
Other Outcomes (2)
Cost utility analysis
12 months after inclusion
Implementation outcomes of the intervention
12 months after the end of the study
Study Arms (2)
Advanced Practice Nurse Follow-up
EXPERIMENTALThe 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 INTERVENTIONShort 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Nantes
Nantes, Loire-Atlantique, 44, France
Related Publications (1)
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. doi: 10.1186/s12877-025-06781-0. Online ahead of print.
PMID: 41275104DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Laure DE DECKER, MD - Pr
Nantes University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2024
First Posted
September 27, 2024
Study Start
October 15, 2024
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
November 15, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- 12 months after primary publication
- Access Criteria
- Agreement
A minimal dataset that allows to interpret, replicate and build upon the findings will be available from the corresponding author on reasonable request.