Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617806
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Advanced Practice Nurses for Fall Incidence PrevenTion in Very Old Robust Adults
Sponsor:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 11 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 ie 246810 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 Lawtons 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 studys 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 11 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 ie 246810 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 Lawtons 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 studys 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None