Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02643069
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2015-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Intervention in Frail Older People (FRAILCLINIC)
Sponsor:
Hospital Universitario Getafe
Organization:
Study Overview
Official Title:
Feasibility and Effectiveness of Frailty Screening and Management Programs Implemented in Different Clinical Settings (FRAILCLINIC)
Status:
COMPLETED
Status Verified Date:
2023-09
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:
FRAILCLINIC
Brief Summary:
Frailty is the main risk factor for the development of incident disability in older people and one of the most important for other adverse outcomes (death, hospitalisation, falls, and permanent institutionalisation).
Although frailty is a frequent condition in older adults who attend hospitals, little is known about its true prevalence in different settings of care. Better knowledge of this issue will inform the rational design of more effective strategies aimed at providing fitted care for these patients. Thus, the current study will potentially have impact on the quality of care for frail patients by revealing the prevalence of frailty in different settings of care, the difficulties in detection and management of frailty in these settings and the best instruments to detect frailty.
The investigators proposal brings together 6 partners in the European Union (EU) from three countries, with the common aim of studying the feasibility of a program to detect frail older patients in high risk clinical settings.
Although frailty is a frequent condition in older adults who attend hospitals, little is known about its true prevalence in different settings of care. Better knowledge of this issue will inform the rational design of more effective strategies aimed at providing fitted care for these patients. Thus, the current study will potentially have impact on the quality of care for frail patients by revealing the prevalence of frailty in different settings of care, the difficulties in detection and management of frailty in these settings and the best instruments to detect frailty.
The investigators proposal brings together 6 partners in the European Union (EU) from three countries, with the common aim of studying the feasibility of a program to detect frail older patients in high risk clinical settings.
Detailed Description:
Quality assurance plan:
* To perform regular monitoring according to the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP): The data will be evaluated according to the protocol and source documents.
* To give training to the centres involved in the study.
* To check the electronic Case Report Form (eCRF)
Data checks to compare data entered into the registry:
The eCRF has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none id card number will not be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.
Plan for missing data to address situations where variables are reported as missing:
The investigators will check the missing data in each eCRF and source documents.
Statistical analysis:
Data will be analyzed using STATA®. Descriptive statistics will be reported and histograms will assess the distribution of frailty scores in each scale. Each analysis will be categorised according to frail, prefrail or robust patients.The prevalence of frailty will be calculated for each scale based on the score thresholds and relationships between frailty and age and other variables will be evaluated. Agreement among scales will be examined using the Cohen kappa statistic. Receiver operator characteristic (ROC) curves will be constructed to compare the area under the ROC curve (AUC) for each scale for available outcomes.
Sample Size: A minimum of 50 patients will be studied in each clinical setting, providing a database of 900 patients.
* To perform regular monitoring according to the International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP): The data will be evaluated according to the protocol and source documents.
* To give training to the centres involved in the study.
* To check the electronic Case Report Form (eCRF)
Data checks to compare data entered into the registry:
The eCRF has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none id card number will not be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.
Plan for missing data to address situations where variables are reported as missing:
The investigators will check the missing data in each eCRF and source documents.
Statistical analysis:
Data will be analyzed using STATA®. Descriptive statistics will be reported and histograms will assess the distribution of frailty scores in each scale. Each analysis will be categorised according to frail, prefrail or robust patients.The prevalence of frailty will be calculated for each scale based on the score thresholds and relationships between frailty and age and other variables will be evaluated. Agreement among scales will be examined using the Cohen kappa statistic. Receiver operator characteristic (ROC) curves will be constructed to compare the area under the ROC curve (AUC) for each scale for available outcomes.
Sample Size: A minimum of 50 patients will be studied in each clinical setting, providing a database of 900 patients.
Study Oversight
Has Oversight DMC:
True
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?: