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

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

Study Overview

• Status: Unknown
• Conditions: Aging; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: digital cognitive training

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rogério Panizzutti; Phone Number: 55 21999090498; Email: rpanizzutti@gmail.com

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil
      • Recruiting
      • Universidade Federal do Rio de Janeiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Executive Function cognitive training; 20 hours of digital cognitive training targeting executive function.	Behavioral: digital cognitive training; 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.
ACTIVE_COMPARATOR: Games; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status score change	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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global cognitive function score change	Global cognitive function score will be measured using the Montreal Cognitive Assessment (MoCA). Thirty items assessing multiple cognitive domains are contained in the MoCA: short-term memory (score range 0-5); visuospatial abilities (score range 0-3), cube copy task (score range 0-1); executive functioning (score range 0-1), phonemic fluency (score range 0-1), verbal abstraction (score range 0-2); attention, concentration, and working memory (score range 0-1), serial subtraction (score range 0-3), digits forward (score range 0-1), and digits backward (score range 0-1); language (score range 0-3), and repetition of complex sentences (score range 0-2); orientation to time and place (score range 0-6), with higher scores indicating better cognition.	3 months
Semantic memory score change	Semantic memory score will be measured using the Verbal fluency test. The verbal fluency test is a short test of verbal functioning. It typically consists of two tasks: category fluency and letter fluency. In the standard versions of the tasks, participants are given 1 min to produce as many unique words as possible within a semantic category (category fluency) or starting with a given letter (letter fluency). The participant's score in each task is the number of unique correct words.	3 months
Selective attention and cognitive flexibility	Selective attention and cognitive flexibility will be measured using the Stroop Test	3 months
Sustained attention and set-shifting	Sustained attention and set-shifting will be measured using the Trial Making Test	3 months
Depression score change	Depression score will be measured using the Geriatric Depression Scale - 15 (Short version). The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. In the Geriatric Depression Scale, questions are answered "yes" or "no." One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".	3 months
Qualitative motivation with the computerized training exercise	Qualitative motivation will be assessed using semi-structured interview	3 months

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2019
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): December 2, 2019

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (ACTUAL): April 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 17976113.1.0000.5257

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No