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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.
Quality assurance plan:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Geriatric Program | Experimental | A comprehensive management plan of the frail patients, covering both in-hospital and postdischarge time, according to the treating physicians (s) surgeon and the performance of a geriatrician . This management will consist of the therapeutic plan, access to geriatric levels of care, coordination with primary and social care, rehabilitation, and discharge plan. |
|
| Usual clinical practice | No Intervention | A comprehensive management plan of the frail patients, covering both in-hospital and postdischarge time, agreed with the treating physicians (s) surgeon. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Geriatric Program | Other | The investigators will implemented programs to detected and manage care for older patients in four settings: Emergency room, oncology department, surgery departments making major surgery and Cardiology. The core intervention will consist of the following elements: comprehensive geriatric assessment, coordination with primary ans social care, integrated and continued care, access to rehabilitation facilities, management of drug treatment avoiding polypharmacy and stressing adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Status assessed using the Barthel index for Basic Activities of Daily Living | will be assessed using the Barthel index for Basic Activities of Daily Living | 36 months |
| Functional Status assessed using the Lawton index for Instrumental Activities of Daily Living | will be assessed using the Lawton index for Instrumental Activities of Daily Living | 36 months |
| Institutionalization (defined as the number of patients newly addressed to nursing) | defined as the number of patients newly addressed to nursing | 36 months |
| Mortality | number of deaths occurred either during hospitalization or at follow-up | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leocadio Rodriguez Mañas, IP | Hospital Universitario de Getafe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopsital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25468154 | Background | Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available. | |
| 16129869 | Background | Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 12, 2013 | Sep 8, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 11253156 | Result | Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. |
| 24559204 | Result | Pena FG, Theou O, Wallace L, Brothers TD, Gill TM, Gahbauer EA, Kirkland S, Mitnitski A, Rockwood K. Comparison of alternate scoring of variables on the performance of the frailty index. BMC Geriatr. 2014 Feb 24;14:25. doi: 10.1186/1471-2318-14-25. |
| 24597624 | Result | Drubbel I, Numans ME, Kranenburg G, Bleijenberg N, de Wit NJ, Schuurmans MJ. Screening for frailty in primary care: a systematic review of the psychometric properties of the frailty index in community-dwelling older people. BMC Geriatr. 2014 Mar 6;14:27. doi: 10.1186/1471-2318-14-27. |
| 24028357 | Result | Theou O, Brothers TD, Mitnitski A, Rockwood K. Operationalization of frailty using eight commonly used scales and comparison of their ability to predict all-cause mortality. J Am Geriatr Soc. 2013 Sep;61(9):1537-51. doi: 10.1111/jgs.12420. Epub 2013 Aug 26. |
| 22836700 | Result | Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2. |
| 38014479 | Derived | Checa-Lopez M, Costa-Grille A, Alvarez-Bustos A, Carnicero-Carreno JA, Sinclair A, Scuteri A, Landi F, Solano-Jaurrieta JJ, Bellary S, Rodriguez-Manas L. Effectiveness of a randomized intervention by a geriatric team in frail hospital inpatients in non-geriatric settings: FRAILCLINIC project. J Cachexia Sarcopenia Muscle. 2024 Feb;15(1):361-369. doi: 10.1002/jcsm.13374. Epub 2023 Nov 28. |