Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)

NCT03911765 | Unknown Phase 1

• 1 other identifier: 17976113.1.0000.5257
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of digital cognitive training in the functionality of older adults with Mild Cognitive Impairment.

Conditions

Mild Cognitive Impairment; Aging

Outcome Measures

Primary Outcomes (1)

• Performance in everyday living score change

  Performance in everyday living score change will be measured using Canadian Occupational Performance Measure (COPM). The Canadian Occupational Performance Measure (COPM) has a client-centered design and measures outcomes according to three occupational performance areas (self-care, productivity, and leisure), examining self-perceived changes in the occupational performance of patients through a semistructured interview. At the beginning, patients start by identifying their difficulties according to the three occupational performance areas. They subsequently use a 10-point scale, ranging from not at all crucial (1) to extremely crucial (10), to identify the intensity of certain difficulties. For the top five problems or tasks selected by patients, the interviewer asks them to continue identifying their performance and satisfaction with their performance by using the same 10-point rating scale.

  3 months

Secondary Outcomes (1)

• Functional status score change

  3 months

Other Outcomes (6)

• Global cognitive function score change

  3 months

• Semantic memory score change

  3 months

• Selective attention and cognitive flexibility

  3 months

Study Arms (2)

Executive Function cognitive training

EXPERIMENTAL

20 hours of digital cognitive training targeting executive function.

Behavioral: digital cognitive training

Games

ACTIVE COMPARATOR

10 hours of computer games c available online which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc), followed by 10 hours of of digital cognitive training targeting executive function.

Behavioral: digital cognitive training

Interventions

digital cognitive training BEHAVIORAL

Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform.

Executive Function cognitive training; Games

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age above 65 years old;
• Elderly enrolled in home for aged in wich the research is taking place;
• Montreal Cognitive Assessment above 21 points;

You may not qualify if:

• Clinical diagnosis of Alzheimer's Disease;
• Serious medical or neurological condition preventing from participation in the study;

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Rogério Panizzutti

CONTACT

21999090498; rpanizzutti@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Model Details: Stepped wedge

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: January 2, 2019
• Primary Completion: July 1, 2019
• Study Completion: December 2, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

BR (1)