Nursing Caries Clinical Trial
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.
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.
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
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