An observational study in Occupational Therapy, Nursing Caries and Aging Disorder, sponsored by University of Salamanca. Status unknown at 1 site in Spain. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by University of Salamanca · Observational
HYPOTHESIS:
The Spanish version of the Everyday Cognition Battery Scale (ECB) is valid and reliable in the Spanish population.
OBJECTIVES:
SPECIFIC OBJECTIVES:
STUDY DESIGN:
Cross-sectional descriptive study. Permission to use the ECB scale will be requested to the author, Allaire JC. Translation and adaptation of the scale.
Administration of the four tests of the ECB to the individuals participating in the study.
Administration of the Rapid Evaluation of Cognitive Functions (RECF) and Lawton and Brody scales.
Analysis of the psychometric characteristics of the translated version.
The protocol has been authorized by the Ethics Committee of the Salamanca health area to make the project possible.
OBJECTIVES:
SPECIFIC OBJECTIVES:
STUDY DESIGN:
Cross-sectional descriptive study. Permission to use the ECB scale will be requested from the author, Allaire JC.
Translation and adaptation of the scale. For the translation and adaptation of the scale, the investigators will follow the steps proposed by Beaton et al. (Spine. 2000;25(24):3186-91):
Administration of the Rapid Evaluation of Cognitive Functions (RECF) and Lawton and Brody scales (adapted and validated in Spanish instruments that will be used as reference standards).
Analysis of the psychometric characteristics of the translated version.
The study was carried out over three years.
This research study was approved by the Bioethics Committee of the University of Salamanca.
SITE - SAMPLE SELECTION:
The study will include healthy older adults, of both sexes who voluntarily participate in the Geriatric Revitalization, Muscle Reeducation and Occupation Therapy Program and Fall Prevention Program, during the years 2018-2020, carried out by the City Council of Salamanca in collaboration with the University School Of Nursing and Physiotherapy of the University of Salamanca, and the students of the Interuniversity Program of Experience based in Ávila, during the years 2019-2020, carried out with the collaboration of the University of Salamanca.
SAMPLE SIZE:
The sample size of the study will be calculated according to the recommendations of Carretero H (International Journal of Clinical and Healthpsychology; 2005;5(3):521-551) which advises that there should be at least five participants for each variable to be studied; and taking into account the sample size used by the author, Allaire JC, for the preparation of the original ECB.
Participants must meet the inclusion/exclusion criteria, who authorized their participation in the study voluntarily and altruistically, through the signature of an informed consent for people with full capacity, having previously received a Participant Information Sheet.
INDEPENDENT VARIABLES:
DEPENDENT VARIABLES:
DESCRIPTION OF THE INTERVENTION: Process description
The four component tests of the ECB will be administered:
The sequence of the ECB tests will be:
ETHICAL-LEGAL ASPECTS OF THE PROJECT: The protocol has been authorized by the Ethics Committee of the Salamanca health area to make the project possible
3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 989 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Salamanca is the lead sponsor of 112 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Older adults without clinical cognitive impairment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Withdrawal Criteria:
Evaluation of cognitive function and evaluation of daily cognition
Everyday cognition
The daily cognition battery called "Everyday Cognition Battery (ECB)" will be used. The ECB assesses cognitive competence in three instrumental activities of daily life: use of medication, management of finances and nutrition and meal preparation. Within the ECB, there are 4 tests, each designed to assess a single cognitive ability: ECB Inductive Reasoning Test or ECU Knowledge Test or Knowledge Test, ECB Computation Span Test (Working Memory) or Amplitude Test Calculation and ECB Recognition Test (Declarative Memory) or Recognition Test (Declarative Memory). For the present study we have selected the latter since it evaluates memory, which led us to think about the importance of memory in the elderly, both measured objectively and subjectively. Within the ECB Recognition Test (Declarative Memory) we have focused on the tests that valued the use of medication.
Time frame: 2 years
Plan to share: Yes — A specific database will be created to which any external researcher can access after contacting by email with the PI (mail: Raquel.jimenez@usal.es)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: We do not establish a specific period of time, access will be permanent.
Access criteria: Researcher upon invitation by mail.
No publications or documents are linked to this record.
Started Apr 2018 (actual). Primary completion is estimated for Dec 2020, 32 months after the start.
Of 515 non-industry observational studies under Cognitive Dysfunction, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 124. This study's planned 32 months is below that.
Counting every sponsor, half of 551 studies reached it within 48 months; a quarter within 21 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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