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/41275104Actively Recruiting
Led by Nantes University Hospital · Updated on 2024-11-15
386
Participants Needed
1
Research Sites
N/A
Total Duration
N
Nantes University Hospital
Lead Sponsor
P
Pôle Fédératif de Soins Primaires (https://dmg.univ-nantes.fr/c/pole-federatif)
Collaborating Sponsor
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
Advanced Practice Nurses for Fall Incidence PrevenTion in Very Old Robust Adults
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening 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
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
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
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
Total: 1 location
1
CHU Nantes
Nantes, Loire-Atlantique, France, 44
Actively Recruiting
L
Laure DE DECKER, MD - Pr
C
Cédric RAT, MD - Pr
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Jérémie Huet, Cédric Rat, Carine Renaux...
https://pubmed.ncbi.nlm.nih.gov/41275104