Validation of a test for assessing frailty in elderly people
Spanish Language Validation, Validity and Reliability Testing of Frail´BESTest in Frail Institutionalized Residents Over 60 Years of Age With Mild Cognitive Impairment
This study is testing a new tool to see if it can accurately measure frailty in older adults, especially those living in care facilities and dealing with mild memory issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 60 Years to 100 Years |
| Sex | All |
| Sponsor | Instituto de Investigación Sanitaria Aragón Academic / other |
| Locations | 1 site (Zaragoza) |
| Trial ID | NCT06438718 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the Frail'BESTest tool for assessing frailty in elderly individuals, particularly focusing on those who are institutionalized and may have mild cognitive impairment. The study is divided into two phases: the first involves linguistic and cultural validation of the test in community-dwelling seniors without cognitive impairment, while the second phase evaluates the validity and reliability of the test in frail institutionalized individuals with and without cognitive impairment. By comparing different groups based on their frailty and cognitive status, the study seeks to enhance the assessment of frailty in older adults.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly individuals over 65 years old, both frail and non-frail, with varying cognitive statuses.
Not a fit: Patients who are younger than 65 or those who do not meet the frailty criteria or cognitive assessment requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable tool for early identification and management of frailty in elderly patients, potentially reducing the risk of falls and hospitalizations.
How similar studies have performed: Other studies have shown success in validating assessment tools for frailty in elderly populations, suggesting that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants should be able to maintain 10seconds stand feet apart without assistance The Validity of FRAILBESTest in mild cognitive impairment institutionalized patients will be made of subgroup categories: Frail/Non-frail; Cognition preserved/Mild cognitive impairment patients and Institutionalized patients/community living individuals. * Frailty will be determine by Fried phenotype Those scoring 3 or more out of 5 will be classify as frail and those scoring 2 or less as non-frail individuals. Mini-Mental State Examination (MMSE) cognition status could be preserved or altered (Score \>24-30). * Community living individuals will be non-frail and cognition should preserved they will be assign to Group A. * Frail institutionalized individual's (scoring from 24 to 26 at MMSE) will be assign to Group B Frail institutionalized individual's (scoring = or \> to 27 at MMSE) will be assign to Group C Non frail Institutionalized individuals with cognition preserved (scoring = or \> to 27 at MMSE) will be assign to group D. Exclusion Criteria: * Orthopedic unstable conditions * Moderate or severe cognitive status Score \<24 at MMSE * Inability to understand indications or communicate with testers. * Sustaining severe cardiac, vascular or respiratory diseases or conditions that contraindicate physical activity * Presenting a condition for which, in the opinion of the researchers, the evaluation may pose a risk to their health * Not having autonomy to decide about their voluntary participation in the study
Where this trial is running
Zaragoza
- Universidad de Zaragoza — Zaragoza, Spain (Recruiting)
Study contacts
- Principal investigator: María del Pilar Domínguez Oliván, PhD — Universidad de Zaragoza
- Study coordinator: María del Pilar Domínguez Oliván, PhD
- Email: sandracalvo@unizar.es
- Phone: +34 876554461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.