Advanced Practice Nurses for Fall Incidence PrevenTion in Very Old Robust Adults

NCT ID: NCT06617806

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2027-10-31

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.

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.

Conditions

Fall Prevention; Autonomy of Older People; Frail Elderly; Advanced Practice Nursing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Advanced Practice Nurse Follow-up

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.

Group Type: EXPERIMENTAL

Follow-up by the Advanced Practice Nurse

Intervention Type: OTHER

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

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Follow-up by the Advanced Practice Nurse

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pôle Fédératif de Soins Primaires (https://dmg.univ-nantes.fr/c/pole-federatif)

UNKNOWN

Sponsor Role: collaborator

Université de Nantes

UNKNOWN

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laure DE DECKER, MD - Pr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

CHU Nantes

Nantes, Loire-Atlantique, France

Site Status: RECRUITING

Countries

France

Central Contacts

Laure DE DECKER, MD - Pr

Role: CONTACT

laure.dedecker@chu-nantes.fr

02.40.08.79.20 ext. +332

Cédric RAT, MD - Pr

Role: CONTACT

cedric.rat@univ-nantes.fr

Facility Contacts

Laure De DECKER, MD PhD

Role: primary

laure.dedecker@chu-nantes.fr

0240083333 ext. +33

Other Identifiers

Mécénat AXA 2022

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RC23_0018

Identifier Type: -

Identifier Source: org_study_id