- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02637518
Comprehensive Validation of Frailty Assessment Tools in Older Adults in Different Clinical and Social Settings (FRAILTOOLS)
A Comprehensive Validation of Frailty Assessment Tools to Screen and Diagnose Frailty in Different Clinical and Social Settings and to Provide Instruments for Integrated Care in Older Adults.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Quality assurance plan:
According to the European's Commission guidelines, the procedure for quality control focuses on the deliverables revision and in the quality of each procedure. The deliverables will be sent to the Administrative committee. The administrative Committee, composed by the Project's Promoter and its associates, will assume the role as a quality manager. It includes the following tasks:
Making sure of the monitoring of all of the changes in documentation. Making sure the activity's coordination and reports are completed according to an adequate quality and in an appropriate manner.
Reviewing the contract deliverables. Monitoring and auditing the project's activities according to plan, making the specific revisions of the contractual deliverables, directed to the achievement of the established objectives.
The electronic Case Report Form (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 identification card number will 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:
Investigator will assess the associations of each scale with the outcome for each setting and outcome through logistic regressions. First, investigators will compute the classification performance (sensitivity, specificity, Receptors Operational Curve (ROC), Area Under the Curve (AUC), predictive values, likelihood ratios) for each model. Second, investigators will study the feasibility of the models taking into account the time needed for the scale and the percentage of patients that can be assessed per case. Investigators will evaluate the sensitivity to change of the scales and the covariance of the scales with other measures as the SPPB through a mixed linear model.
Sample Size: Participants will be recruited in Spain, Italy, France, United Kingdom and Poland. The total sample will be of 1.940 subjects. Each participating centre will have to recruit a total of 388 patients, corresponding to 97 subjects in each clinical setting by centre.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD
- Phone Number: 2760 +34 916839360
- Email: leocadio.rodriguez@salud.madrid.org
Study Contact Backup
- Name: MARTA CHECA LOPEZ, MD
- Phone Number: 2760 +34 916839360
- Email: marta.checa@salud.madrid.org
Study Locations
-
-
Madrid
-
Getafe, Madrid, Spain, 28905
- Recruiting
- Hospital Universitario de Getafe
-
Contact:
- LEOCADIO RODRIGUEZ MAÑAS, MD, PhD
- Phone Number: 2760 +34916839360
- Email: leocadio.rodriguez@salud.madrid.org
-
Contact:
- MARTA CHECA LOPEZ, MD
- Phone Number: 2760 +34916839360
- Email: marta.checa@salud.madrid.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- People older than 75 years old, who sign the informed consent after accepting their participation.
Exclusion Criteria:
- General exclusion criteria will be an MMSE score less than 20 points or having a terminal illness (life expectancy < 6 months).
- Subjects included from the hospital ward (Acute Geriatric Unit and Outpatient
- Geriatric Consultation) and primary care will have additional exclusion criteria: dependency in more than 2 Instrumental Activities of Daily Living (IADL) in women (Lawton < 6), and in more than 3 IADL in men (Lawton < 5).
- Subjects seen in a nursing home setting will be excluded if they obtain less than 40 points in the Barthel index.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hospital Universitario de Getafe
Assessment of frailty tools in elderly people The Geriatric Department attends patients: 1800/year - acute unit. 800/year - Orthogeriatrics and Interconsultation Unit. 300/year - Day Hospital. 4000/year - Outpatient office. 1200/year - Domiciliary Care. |
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care.
To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
|
Diabetes Frail Ltd.
Assessment of frailty tools in elderly people Has significant experience in managing research studies in older people.
|
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care.
To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
|
Università Cattólica del Sacro Cuore
Assessment of frailty tools in elderly people The Geriatric Unit is compounded by: 24 beds of Acute Care Ward 46 beds of Intensive Rehabilitation Unit 20 beds of Day Hospital Outpatient clinic |
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care.
To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
|
Gérontopole de Toulouse
Assessment of frailty tools in elderly people The Geriatric Unit is compounded by: 5 Acute Care Units - 100 beds. 3 Rehabilitation Unit - 75 beds. Long term care Unit - 140 beds. 2 Day Hospitals Outpatient Clinic |
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care.
To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
|
Jagiellonian University Medical College
Assessment of frailty tools in elderly people The Department of Internal Medicine and Gerontology is the largest centre in Poland limited to the Geriatric market.
|
Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care.
To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 18 months
|
data obtained from the official registration of the country of the corresponding partner.
When not available, other methods will be used (asking to a proxy, calls to nursing homes, medical registries, etc.).
|
18 months
|
Functional disability
Time Frame: 18 months
|
Defined as a loss of at least one point in the Short Physical Performance Battery (SPPB).
|
18 months
|
Disability to perform IADL
Time Frame: 18 months
|
Defined as a loss of at least one point in the Lawton Index
|
18 months
|
Disability to perform BADL
Time Frame: 18 months
|
Defined as a loss of at least one point in the Barthel Index.
|
18 months
|
Falls
Time Frame: 18 months
|
Data will be collected by the participant's verbal recall (self-assessed) and will be registered in the electronic Case Report Form (eCRF).
|
18 months
|
Incident cognitive impairment
Time Frame: 18 months
|
Defined by a reduction of 2 or more points in the Mini-Mental State Examination (MMSE).
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frailty classification performance
Time Frame: 18 months
|
Performance of the instruments by clinical setting: six frailty assessment tools will be used in four different levels of care.
The performance of each scale in the classification of frailty will be established.
|
18 months
|
Tool feasibility
Time Frame: 18 months
|
Composed by two main conditions: the percentage of people that are assessed by each tool in each setting (adequacy) and the time for carrying out the the tool assessment.
|
18 months
|
Sensitivity to change in frailty status
Time Frame: 18 months
|
Evaluate the changes in the assessment level of patients observed at 12 and 18 months with each of the tools and their correlations with the changes observed in the patient´s functional status.
|
18 months
|
Qualification as a screening and/or diagnosis tool
Time Frame: 18 months
|
Evaluate the utility of each scale as a frailty detection method for screening or diagnosis, using pre-established criteria.
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD, Hospital Universitario de Getafe
Publications and helpful links
General Publications
- 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.
- 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.
- Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23. doi: 10.1001/archinte.166.4.418.
- Fried LP, Guralnik JM. Disability in older adults: evidence regarding significance, etiology, and risk. J Am Geriatr Soc. 1997 Jan;45(1):92-100. doi: 10.1111/j.1532-5415.1997.tb00986.x.
- Rodriguez-Manas L, Sinclair AJ. Frailty: the quest for new domains, clinical definitions and subtypes. Is this justified on new evidence emerging? J Nutr Health Aging. 2014 Jan;18(1):92-4. doi: 10.1007/s12603-013-0433-9. No abstract available.
- Garcia-Garcia FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Manas L. A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014 May;15(5):371.e7-371.e13. doi: 10.1016/j.jamda.2014.01.004. Epub 2014 Mar 2.
- Oviedo-Briones M, Rodriguez-Laso A, Carnicero JA, Gryglewska B, Sinclair AJ, Landi F, Vellas B, Rodriguez Artalejo F, Checa-Lopez M, Rodriguez-Manas L. The ability of eight frailty instruments to identify adverse outcomes across different settings: the FRAILTOOLS project. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1487-1501. doi: 10.1002/jcsm.12990. Epub 2022 Apr 15.
- Checa-Lopez M, Oviedo-Briones M, Pardo-Gomez A, Gonzales-Turin J, Guevara-Guevara T, Carnicero JA, Alamo-Ascencio S, Landi F, Cesari M, Grodzicki T, Rodriguez-Manas L; FRAILTOOLS consortium. FRAILTOOLS study protocol: a comprehensive validation of frailty assessment tools to screen and diagnose frailty in different clinical and social settings and to provide instruments for integrated care in older adults. BMC Geriatr. 2019 Mar 18;19(1):86. doi: 10.1186/s12877-019-1042-1.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 662887
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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