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Occupational TherapyNCT04169633

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

An observational study of Occupational Therapy and Nursing Caries, run by University of Salamanca at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Cognitive Function Evaluation
How many people
200 participants
Where
1 siteSpain
Study dates
1 Apr 2018to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Older adults without clinical cognitive impairment

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Eduardo José IP Fernández, PhD contact

699244390

edujfr@usal.es

Spain1 site, 1 recruiting
  • Eduardo José Fernández

    Salamanca, 37002

    Eduardo JOsé IP Fernández, PhD, 699244390, edujfr@usal.es

    Recruiting

Other trials in Spain

About this study

Official title: Spanish Adaptation and Validation of the Everyday Cognition Battery of Assessment of Daily Cognition in Older Adults.

HYPOTHESIS:

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

Read more

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.
  1. Subsequently, the RECF and a scale of assessment of Instrumental Activities of Daily Life (IADL), Lawton \& Brody Scale will be administered.
  2. 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

Being tested
Cognitive Function Evaluation
Keywords
Everyday cognition, Older adult, aging, test Validation
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Function EvaluationDiagnostic test

    Evaluation of cognitive function and evaluation of daily cognition

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2019
  2. Study start1 Apr 2018
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04169633
Sponsor's protocol ID
0000302
Status last verified
Nov 2019
First submitted
13 Nov 2019
Last updated
20 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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)

Questions about this trial

What is this clinical trial studying?

An observational study of Occupational Therapy and Nursing Caries, run by University of Salamanca at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eduardo José IP Fernández, PhD (699244390, edujfr@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Everyday cognition (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.

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