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

Phase 1

• Conditions: Mild Cognitive Impairment; Aging
• Interventions: Behavioral: digital cognitive training

• Registration Number: NCT03911765
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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.

Detailed Description

Mild Cognitive Impairment (MCI) is characterized by decline in one or more cognitive domains, including memory, attention, executive functions, language and visuospatial abilities, and in a significant portion of cases may evolve to Alzheimer's Disease. According to established diagnostic criteria, independence for daily life activities is preserved, but activities are carried out less effectiveness and efficiency, affected subjects usually take more time and make more mistakes, when compared to their pre-morbid performance. Different studies have observed that impairments in functional performance in older adults with MCI are associated with impairments in executive function. This study intends to verify the impact of the use of digital cognitive training for executive function on the functionality of older adults with MCI. 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. The active control group will play computer games available online. Both groups will play for 1 hour at least 2 times per week.

After baseline assessments, older adults with MCI will be stratified by age, education, gender, functional measurement and cognitive assessment, and randomly assigned to the intervention group with digital cognitive exercises or to the control group with computer games, in a stepped wedge design. Subjects will be evaluated at baseline and after completing 10 and 20 hours of intervention. After the first 10 hours of intervention both groups will be assigned to the intervention with digital cognitive exercises for additional 10 hours. Both groups will be comparable in terms of personal contact with staff and computer time. Our hypothesis is that the training using digital cognitive exercises will improve the executive function and that this gain has a positive impact on the functionality and accomplishment of the daily life activities of older adults with MCI.

Study Timeline

• Study Start: 2019-01-02
• Status Verified: 2019-04
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17
• Primary Completion: 2019-07-01
• Study Completion: 2019-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Executive Function cognitive training	digital cognitive training	20 hours of digital cognitive training targeting executive function.
Games	digital cognitive training	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.

Primary Outcome Measures

Name	Time	Method
Performance in everyday living score change	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Functional status score change	3 months	Functional status score will be measured using the Direct Assessment of Functional Status-Revised (DAFS-R). DAFS-R assesses seven different domains of functional abilities by requiring the participant to carry out different tasks, two domains will be evaluated: dealing with Finances (score range 0-32) and shopping skills (score range 0-20), with higher scores indicating better functioning.

Trial Locations

Locations (1)

Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil