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.
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
- Conditions the study is for
- Occupational Therapy, Nursing Caries, Aging Disorder
- 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.
Spain1 site, 1 recruiting
- Recruiting
Eduardo José Fernández
Salamanca, 37002
Eduardo JOsé IP Fernández, PhD, 699244390, edujfr@usal.es
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
- 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.
- 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.
- Next, a document called Clinical History will be delivered to collect personal data and demographic characteristics of the participant.
- 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.
- Subsequently, the RECF and a scale of assessment of Instrumental Activities of Daily Life (IADL), Lawton \& Brody Scale will be administered.
- 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.
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.
- First posted20 Nov 2019
- Study start1 Apr 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Eduardo J Fernández Rodríguez, University of Salamanca
- Investigators
- Eduardo José IP Fernández, PhD, Principal investigator, University of Salamanca
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)
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish Adaptation and Validation of the Everyday Cognition Battery of Assessment of Daily Cognition in Older Adults.
- ClinicalTrials.gov ID
- NCT04169633
- Acronym / sponsor ID
- 0000302
- Keywords
- Everyday cognition, Older adult, aging, test Validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- 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.
- Next, a document called Clinical History will be delivered to collect personal data and demographic characteristics of the participant.
- 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.
- Subsequently, the RECF and a scale of assessment of Instrumental Activities of Daily Life (IADL), Lawton \& Brody Scale will be administered.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults without clinical cognitive impairment
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Cognitive impairment with clinical diagnosis.
- Absence of numerical and literacy skills.
- Not authorizing the participation in the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Function EvaluationEvaluation of cognitive function and evaluation of daily cognition | Diagnostic test | – |
Primary outcome
Everyday cognition
Time frame: 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: 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)
Related trials for Occupational Therapy
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
Not yet recruiting
COG+OT Telerehabilitation for Adults With Subjective Cognitive Complaints
Subjective Cognitive Complaints, Ehlers-Danlos Syndrome
Recruiting
Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities
Disabilities Physical, Falls
Active, not recruiting
Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT
Stress, Psychological, Occupational, Stress, Psychological
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo José IP Fernández, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
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.