ClinicalTrials.gg
Status unknownNCT04169633Updated Nov 20, 2019

Spanish Adaptation and Validation of the Everyday Cognition Battery (ECB).

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

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
60 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • Providing a validated scale in Spanish that evaluates 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 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):

  • Stage I: translation of the scale from the original English version to Spanish. Two translations will be performed: one by the principal investigator and another by the Central Language Service of the University of Salamanca.
  • Stage II: synthesis of translations and solution of discrepancies, carried out by the research team.
  • Stage III: reverse translation or retro-translation, from the target language (Spanish) to the original language (English).
  • Stage IV: pilot test (pre-test). Administration of the four tests of the translated version to the ECB to the individuals participating in the study.

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:

  • Demographic data of the subject: age, sex, marital status, level of education, lifestyle (lives alone yes/no), physical exercise (yes/no).

DEPENDENT VARIABLES:

  • Score obtained in each ECB test
  • Score obtained in the Rapid Evaluation of Cognitive Functions (RECF).

DESCRIPTION OF THE INTERVENTION: Process description

  1. Subjects interested in participating in the study will receive a Participant Information Sheet, explaining the objectives and procedures of the research study. It also refers to the principles of non-maleficence, autonomy and participation and voluntary withdrawal, data protection and confidentiality.
  2. After the clarifications requested, informed consent will be given to people with full capacity, who will read and sign if they agree to be part of the study.
  3. Next, a document called Clinical History will be delivered to collect personal data and demographic characteristics of the participant.
  4. The four component tests of the ECB will be administered:

    The sequence of the ECB tests will be:

    • ECB Knowledge Test
    • ECB Recognition Test - Declarative Memory
    • ECB Inductive Reasoning Test
    • ECB Calculation Test - Retention Capaccity of the ECB The time taken to complete the self-administered tests will be that required by each participant, and the estimated time to complete the hetero-administered test is about 7 minutes.
  5. Subsequently, the RECF and a scale of assessment of Instrumental Activities of Daily Life (IADL), Lawton \& Brody Scale will be administered.
  6. The number of sessions will be necessary until the statistically calculated sample is obtained.

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

02

Conditions studied

  • Occupational Therapy
  • Nursing Caries
  • Aging Disorder
  • Cognitive Disorders

Keywords

  • Everyday cognition
  • Older adult, aging
  • test Validation
03

In context

Cognitive Dysfunction

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Cognitive impairment with clinical diagnosis.
  2. Absence of numerical and literacy skills.
  3. Not authorizing the participation in the study.

Withdrawal Criteria:

  1. Participants who decide to leave the study in any of its phases, despite having signed the informed consent.
  2. Not having completed more tan 50% of the administered scale.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testCognitive Function Evaluation

    Evaluation of cognitive function and evaluation of daily cognition

06

What researchers measure

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.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Eduardo José Fernández
    Salamanca, 37002, Spain
    • Eduardo JOsé IP Fernández, PhD · Contact · edujfr@usal.es · 699244390
    Recruiting
08

References and documents

Individual participant data

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Nov 13, 2019
First posted
Nov 20, 2019
StartActual
Apr 1, 2018
Primary completionEst.
Dec 31, 2020
CompletionEst.
Dec 31, 2020
Last update
Nov 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04169633
Responsible party
Prof. Dr. Eduardo J Fernández Rodríguez (Principal Investigator, University of Salamanca) — Principal investigator
First posted
Nov 20, 2019
Start date
Apr 1, 2018
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Nov 20, 2019

Study contacts

Eduardo José IP Fernández, PhD
Contact
edujfr@usal.es
699244390
Eduardo José IP Fernández, PhD
principal investigator · University of Salamanca

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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