NCT05688163

Brief Summary

To evaluate the effectiveness of a daily cognition training programme versus a traditional cognitive stimulation programme in cognitively unimpaired older adults on cognitive function, emotional state, frailty and functionality.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

January 8, 2023

Last Update Submit

April 13, 2023

Conditions

Keywords

Functional StatusCognition TherapyCognitive ImpairmentOccupational therapy

Outcome Measures

Primary Outcomes (1)

  • Everyday cognition.

    The Test for the Assessment of Everyday Cognition measures the ability of older people to solve everyday problems through performance tasks whose resolution depends on their cognitive capacity. The abilities tested are planning ability and cognitive flexibility, verbal working memory, reasoning, episodic memory, episodic memory and crystallised intelligence. The result is a direct estimation of the person's functional capacity by means of 12 real situations grouped into 6 areas: medication, administrative management, financial management, meal preparation, transport and shopping. The administration time is about 35 minutes.

    35 minutes

Secondary Outcomes (5)

  • Cognitive function.

    10 minutes

  • Emotional state.

    10minutes

  • Instrumental activities of daily living

    5 minutes

  • Functionality.

    15 minutes

  • Fragility.

    5 minutes

Study Arms (2)

traditional cognitive stimulation

ACTIVE COMPARATOR

The control group will carry out the programme based on traditional cognitive stimulation. Individual cognitive skills such as attention, memory, executive functions, orientation, praxis, calculation, visual perception and reasoning will be trained. The materials and media used will be a cognitive stimulation notebook created for the study which includes cards in printed paper format to be completed by the participants.

Other: traditional cognitive stimulation

programme based on everyday cognition

EXPERIMENTAL

The experimental group, on the other hand, will carry out a programme based on everyday cognition, i.e. the use of cognitive functions to solve real everyday problems that occur in our daily lives and that allow us to be autonomous in our homes, such as preparing food, taking care of the house, using transport, shopping, using the telephone, medication, financial management and access to information and current affairs. As material for use as for the traditional cognitive stimulation sessions, a training booklet on everyday cognition has been created which includes all the sessions mentioned above.

Other: programme based on everyday cognition

Interventions

Will carry out a programme based on everyday cognition, As material for use as for the traditional cognitive stimulation sessions, a training booklet on everyday cognition has been created which includes all the sessions mentioned above. Each day one of these tasks will be worked on.

programme based on everyday cognition

Individual cognitive skills such as attention, memory, executive functions, orientation, praxis, calculation, visual perception and reasoning will be trained. The materials and media used will be a cognitive stimulation notebook created for the study which includes cards in printed paper format to be completed by the participants.

traditional cognitive stimulation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be aged 60 years or older.
  • Voluntarily sign the informed consent form about the project, authorising their participation.
  • Carry out the initial assessment.
  • Be admitted to the programme from the start of the programme.

You may not qualify if:

  • No literacy skills or significant deficits in language comprehension.
  • Institutionalised person.
  • Have a clinical diagnosis of cognitive impairment.
  • Participate in another cognitive stimulation programme during the intervention process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eduardo José Fernández Rodríguez

Salamanca, España, 37002, Spain

Location

Related Publications (1)

  • Saez-Gutierrez S, Fernandez-Rodriguez EJ, Sanchez-Gomez C, Garcia-Martin A, Barbero-Iglesias FJ, Sanchez Aguadero N. Study protocol for a randomized controlled trial: Effect of an everyday cognition training program on cognitive function, emotional state, frailty and functioning in older adults without cognitive impairment. PLoS One. 2024 Mar 29;19(3):e0300898. doi: 10.1371/journal.pone.0300898. eCollection 2024.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 18, 2023

Study Start

June 1, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

All data will be made available upon request by contacting the following e-mail address: edujfr@usal.es.

Shared Documents
STUDY PROTOCOL
Time Frame
From the start of recruitment until two years after the end of recruitment.
Access Criteria
All data will be made available upon request by contacting the following e-mail address: edujfr@usal.es.

Locations