Actively Recruiting

Phase Not Applicable
Age: 80Years +
All Genders
ID06617806

Advanced Practice Nurses for Fall Incidence PrevenTion in Robust Very Old Adults: Protocol for the APN-FIT Hybrid Randomized Controlled Trial

Led by Nantes University Hospital · Updated on 2024-11-15

386

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Nantes University Hospital

Lead Sponsor

P

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of an Advanced Practice Nurse (APN) led fall prevention program compared to standard care in non-frail adults aged 80 and above. This pragmatic, open-label, randomized trial is conducted in multiple primary care centers in the Pays de la Loire region of France. The study aims to improve fall prevention and assess implementation outcomes by including a full geriatric assessment for all participants and offering voluntary physical activity programs. Participants are randomly assigned to either receive follow-up care by an APN along with their general practitioner or to continue with usual care. The APN group receives scheduled follow-ups at 1, 3, 6, 9, and 12 months after enrollment, with personalized recommendations and coordination with other healthcare providers. Both groups receive comprehensive geriatric assessments at the start and after 12 months, and all participants are invited to participate in a home-based physical activity program consisting of 14 sessions over 7 weeks. During the study, falls are recorded at 2, 4, 6, 8, 10, and 12 months. Researchers will evaluate outcomes including the number of falls, independence levels, healthcare utilization, frailty, cognitive and mental health, nutritional status, and quality of life. Data collection is done by research staff using blinded methods. An ancillary study investigates the program's implementation factors by conducting interviews and observations with patients and healthcare providers. The total participation duration is 12 months with regular assessments and follow-ups.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 80Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 80 or over
  • Classified as vigorous on the Clinical Frailty Scale (scores 1, 2, or 3)
  • Have a referring primary care physician working with a local Advanced Practice Nurse
  • Affiliated to a Health Care Plan
  • Informed and have signed consent to participate in the research
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Baseline Assessment and Enrollment

Duration - Baseline visit

Participants undergo a comprehensive geriatric assessment (CGA) performed by an Advanced Practice Nurse (APN) at enrollment. A home-based physical activity program with twice-weekly sessions is introduced to all participants.

1 visit (in-person) at enrollment

Intervention Period

Duration - 7 weeks

Participants receive a home-based physical activity program consisting of 14 sessions over 7 weeks. In the intervention group, the APN schedules follow-ups to monitor and adjust recommendations.

14 home-based physical activity sessions (45 minutes each); for intervention group, follow-ups at 1, 3, 6, 9, and 12 months post-inclusion

Data Collection Follow-up

Duration - 12 months

Participants are contacted every two months by research staff to collect data on falls and secondary outcomes in a blinded approach.

Contacts at 2, 4, 6, 8, 10, and 12 months post-inclusion

Final Assessment

Duration - 1 visit at 12 months

A new comprehensive geriatric assessment (CGA) is performed at 12 months to evaluate participant outcomes.

1 visit (in-person) at 12 months

Trial Site Locations

Total: 1 location

1

CHU Nantes

Nantes, Loire-Atlantique, France, 44

Actively Recruiting

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Research Team

L

Laure DE DECKER, MD - Pr

C

Cédric RAT, MD - Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

Advanced practice nurses for fall incidence prevention in robust very old adults: protocol for the APN-FIT hybrid randomized controlled trial.

Jérémie Huet, Cédric Rat, Carine Renaux...

https://pubmed.ncbi.nlm.nih.gov/41275104