NCT04169633

Brief Summary

HYPOTHESIS: The Spanish version of the Everyday Cognition Battery Scale (ECB) is valid and reliable in the Spanish population. OBJECTIVES:

  • Providing a validated scale in Spanish to evaluate daily cognition in older adults. SPECIFIC OBJECTIVES:
  • Translating the original English version of the ECB into Spanish.
  • Adapting the scale to the sociocultural context of Spain.
  • Checking the psychometric characteristics (reliability and validity) of the translated version . 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

November 13, 2019

Last Update Submit

November 15, 2019

Conditions

Keywords

Everyday cognitionOlder adult, agingtest Validation

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Interventions

Evaluation of cognitive function and evaluation of daily cognition

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Older adults without clinical cognitive impairment

You may qualify if:

  • Being older than 60 years old.
  • Voluntary participation in the Geriatric Revitalization, Muscle Reeducation and Occupation Therapy Program and Fall Prevention Program or in the Interuniversity Program of Experience.
  • Signing an informed consent.

You may not qualify if:

  • Cognitive impairment with clinical diagnosis.
  • Absence of numerical and literacy skills.
  • Not authorizing the participation in the study.
  • Withdrawal Criteria:
  • Participants who decide to leave the study in any of its phases, despite having signed the informed consent.
  • Not having completed more tan 50% of the administered scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eduardo José Fernández

Salamanca, 37002, Spain

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Eduardo José IP Fernández, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo José IP Fernández, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 20, 2019

Study Start

April 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 20, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
We do not establish a specific period of time, access will be permanent.
Access Criteria
Researcher upon invitation by mail.

Locations