Comprehensive Validation of Frailty Assessment Tools in Older Adults in Different Clinical and Social Settings

Syndrome Clinical Trial

— FRAILTOOLS  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02637518
• Other study ID #: 662887
• Status: Recruiting
• Phase: N/A
• First received: December 16, 2015
• Last updated: August 23, 2016
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: August 2016
• Source: Hospital Universitario Getafe
• Contact: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD
• Phone: +34 916839360
• Email: leocadio.rodriguez[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial Summary

There is a proved strong evidence of the usefulness of frailty as a predictive factor of relevant and desired outcomes in populations of older adults. Several studies have been published showing the utility of the concept in improving the prognosis accuracy and the prediction of different risks (hospitalisations, surgical and non surgical complications, length of stay, death, incident disability, etc.) in emergency departments, surgical patients, and inpatients with cardiovascular disease. The studies have placed the focus in assessing population risk, while the validation process for these instruments as diagnosis or screening tools has been usually neglected. FRAILTOOLS aims to assess the usefulness as screening and diagnosis tools of some selected instruments to detect frailty in both clinical (Hospital and Primary Care) and social (Nursing Homes) settings, providing diagnostic algorithms clinically sound. Target groups are all of those older adults at risk of frailty (pre-frail) plus those that are frail and are at risk for developing disability. According to the published prevalence of these two conditions, the target population concerned by this project represents around 40-50% of people older than 65, and 60-70% of people older than 75. Once determining the best tools of screening and diagnosis in different settings of care, investigators will research conclusions of these people wherever the level of care they need and currently use. The benefit will spend to the Health System and Social Care as it will provide validated instruments that are necessary to provide an appropriate care for older adults by means of a comprehensive, continued, coordinated and integrated care.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1940
• Est. completion date: May 2018
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Syndrome

Intervention

Other:
• Assessment of frailty tools in elderly 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)

Locations

Country	Name	City	State
Spain	Hospital Universitario de Getafe	Getafe	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Getafe	European Commission

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Fried LP, Guralnik JM. Disability in older adults: evidence regarding significance, etiology, and risk. J Am Geriatr Soc. 1997 Jan;45(1):92-100. Review. — View 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. — View Citation

García-García FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Mañas 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. — View Citation

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. — View Citation

Rodriguez-Mañas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. — View Citation

Rodríguez-Mañas 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	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	No
Primary	Functional disability	Defined as a loss of at least one point in the Short Physical Performance Battery (SPPB).	18 months	No
Primary	Disability to perform IADL	Defined as a loss of at least one point in the Lawton Index	18 months	No
Primary	Disability to perform BADL	Defined as a loss of at least one point in the Barthel Index.	18 months	No
Primary	Falls	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	No
Primary	Incident cognitive impairment	Defined by a reduction of 2 or more points in the Mini-Mental State Examination (MMSE).	18 months	No
Secondary	Frailty classification performance	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	No
Secondary	Tool feasibility	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	No
Secondary	Sensitivity to change in frailty status	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	No
Secondary	Qualification as a screening and/or diagnosis tool	Evaluate the utility of each scale as a frailty detection method for screening or diagnosis, using pre-established criteria.	18 months	No