Advanced Practice Nurses for Fall Incidence PrevenTion in Very Old Robust Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age80+
SponsorNantes University Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Follow-up by the Advanced Practice Nurse
Other interventionAt 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
Treatment groups
386 Participants
are divided into 2 treatment groupsGroup A: Advanced Practice Nurse Follow-upExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
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
Time frame
12 months after enrollment in the studySecondary outcomes
1
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"
Time frame
2-4-6-8-10 and 12 months after inclusion2
Level of independance
Activities of daily living (Katz index) and Lawton's instrumental activities of daily livng
Time frame
12 months after inclusion3
Level of healthcare utilization
Number of consultations, utilization of dental, ophthalmological, and ear-nose-throat care during the follow-up period
Time frame
12 months after inclusion4
Level of emergency care service utilization
Number of stays in an emergency hospitalization unit during the follow-up period.
Time frame
12 months after inclusionOther outcomes
1
Cost utility analysis
Rate of Differential Cost - Utility
Time frame
12 months after inclusion2
Implementation outcomes of the intervention
* Acceptability: Perception, among caregivers, that a given treatment, service, practice, or innovation is satisfactory * Relevance: Perception of the adequacy of the innovation to address a particular question or problem * Adoption: Intention, initial decision, or action to try or use an innovation * Efficiency: Assess the price that society is willing to pay to guarantee the health gain associated with the intervention * Feasibility: The extent to which an innovation can be successfully implemented within a given organization * Fidelity: The degree to which an intervention has been implemented as prescribed in the original protocol * Scope: Number of people affected by an intervention and their representativeness of the target population * Permanence: The presence of continuity beyond the study regarding the health benefits for the population related to the intervention and the means put in place to ensure it
Time frame
12 months after the end of the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Nantes University Hospital
Lead sponsor
Pôle Fédératif de Soins Primaires (https://dmg.univ-nantes.fr/c/pole-federatif)
Collaborator
Université de Nantes
Collaborator
Source ClinicalTrials.gov