Study of a Daily Cognition Training Program

NCT04041999 | Completed DMC

• 1 other identifier: 000263
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

Brief Summary

HYPOTHESIS In older adults who receive a direct intervention from the perspective of occupational therapy with a "Training Program in Daily Cognition", there are greater benefits, both in the overall cognitive performance and in the levels of daily cognition, that in the older adults who receive an intervention based on a "Traditional Cognitive Stimulation Program", achieving not only an improvement or maintenance of cognitive functions, but a generalization and transfer of that improvement in their daily lives and occupational performance. OBJECTIVES: To evaluate the effectiveness of a "Training Program in Daily Cognition" in the elderly, to improve the levels of daily cognition and global cognitive performance. SPECIFIC OBJECTIVES: Compare the difference in levels of daily cognition between the participants of the control group who carry out a "Traditional Cognitive Stimulation Program" and the participants of the experimental group who carry out a "Training Program in Daily Cognition". Analyze if there is a difference in the levels of global cognitive performance between the participants of the control group that carry out a "Traditional Cognitive Stimulation Program" and the participants of the experimental group that carry out a "Training Program in Daily Cognition". To study the relationship between standard psychometric tests that measure cognitive performance and the ECB Daily Cognition Battery Recognition Test that measures daily cognition. Analyze if there is a relationship between age and cognitive performance and the daily cognition of the elderly. Describe the relationship between the educational level that the participants possess and the cognitive performance and their daily cognition Evaluate the impact of gender in the elderly with cognitive performance and daily cognition. Check whether or not physical activity influences the cognitive performance and daily cognition of study participants. STUDY DESIGN: Experimental, randomized, stratified, prospective, longitudinal study using a parallel scheme of fixed allocation experimental group and control group. The protocol has been authorized by the Ethics Committee of the Salamanca health area to make the project possible.

Conditions

Occupational Therapy; Cognition Disorders in Old Age; Cognitive Dysfunction; Rehabilitation

Keywords

Occupational therapy; cognition; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Cognitive function

  Rapid evaluation of cognitive functions (ERFC)

  Up to 3 years

• Everyday cognition

  Everyday Cognition Battery (ECB)

  Up to 3 years

Study Arms (2)

Daily Cognition Training Program

EXPERIMENTAL

The intervention was administered by a qualified professional, in this case an occupational therapist. And it was always individually through specific activities or exercises. Tasks are carried out in which the subject has to exercise different cognitive functions (praxies, attention, language, memory orientation, gnosias and executive functions; mainly working memory decision making, planning, reasoning and temporal estimation) during the development of AIVD For this, similar materials are used to those that the elderly could find in daily tasks or when solving day-to-day problems. Specifically we focus on tasks related to taking medication and adherence to treatment.

Behavioral: Daily Cognition Training Program

Traditional Cognitive Stimulation Program

ACTIVE COMPARATOR

The intervention was administered by a qualified professional, in this case an occupational therapist. And it was always individually through specific activities or exercises. Tasks are performed to work various cognitive functions.

Behavioral: Daily Cognition Training Program

Interventions

Daily Cognition Training Program BEHAVIORAL

Tasks are carried out in which the subject has to exercise different cognitive functions (praxies, attention, language, memory orientation, gnosias and executive functions; mainly working memory decision making, planning, reasoning and temporal estimation) during the development of AIVD For this, similar materials are used to those that the elderly could find in daily tasks or when solving day-to-day problems. Specifically we focus on tasks related to taking medication and adherence to treatment. Some examples of tasks are: the management of a medical prescription, expiration of a medication, understanding of the prescriptions made by the doctor, guidelines for taking medication (doses, schedules ...) and indications and contraindications, filling pill boxes, recall of controls doctors, medication control, prospective memory of medical management, etc.

Daily Cognition Training Program; Traditional Cognitive Stimulation Program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 60 years of age and voluntarily enroll in the Occupational Therapy Program.
• Be accepted in the Occupational Therapy Program.
• Perform the initial assessment.
• Voluntarily authorize their participation in the study, by signing an informed consent.

You may not qualify if:

• Present cognitive impairment with clinical diagnosis.
• Not have numerical and literacy skills.
• Do not authorize your participation in the study.
• Participate in some other cognitive stimulation program regularly.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Eduardo José Fernández Rodríguez

Salamanca, España, 37002, Spain

Location

Related Publications (1)

• Gomez CS, Rodriguez EJF. The effectiveness of a training programme in everyday cognition in healthy older adults: a randomised controlled trial. BMC Geriatr. 2021 Jan 28;21(1):79. doi: 10.1186/s12877-020-01998-7.

  PMID: 33509113 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Eduardo José Fernández Rodríguez, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Occupational therapy. University of Salamanca.

Model Details: Experimental, randomized, stratified, prospective, longitudinal study using a parallel scheme of fixed allocation experimental group and control group

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 1, 2019
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We do not establish a specific period of time, access will be permanent.
• Access Criteria: Investigador previa invitación por correo

Locations

ES (1)