Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-31 @ 6:35 PM
Study NCT ID:
NCT06617806
Status:
RECRUITING
Last Update Posted:
2024-11-15
First Post:
2024-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Practice Nurses for Fall Incidence PrevenTion in Very Old Robust Adults
Sponsor:
Nantes University Hospital
Organization:
Study Overview
Official Title:
Advanced Practice Nurses for Fall Incidence PrevenTion in Robust Very Old Adults: Protocol for the APN-FIT Hybrid Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APN-FIT
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Mécénat AXA 2022 | OTHER_GRANT | AXA Life Insurance Company | View |