Syndrome Clinical Trial
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.
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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