Clinical trial NCT02643069: Clinical Intervention in Frail Older People (FRAILCLINIC)
Official title: Feasibility and Effectiveness of Frailty Screening and Management Programs Implemented in Different Clinical Settings (FRAILCLINIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty Syndrome
Keywords: Frailty
Frailty tools
Clinical settings
Disability
Quality of life
Functional Autonomy
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 821
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Frailty patients older than 75 years old attended in the settings of care.
2. Willing and able to provide informed consent

Exclusion Criteria:

1. Lack of capacity to give informed consent.
2. Those unable or unwilling to cooperate with any of the assessments

Primary outcomes:
measure: Functional Status assessed using the Barthel index for Basic Activities of Daily Living
timeFrame: 36 months
measure: Functional Status assessed using the Lawton index for Instrumental Activities of Daily Living
timeFrame: 36 months
measure: Institutionalization (defined as the number of patients newly addressed to nursing)
timeFrame: 36 months
measure: Mortality
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hopsital Universitario de Getafe
state: Madrid
Study officials:
affiliation: Hospital Universitario de Getafe
name: Leocadio Rodriguez Mañas, IP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.