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

Primary Purpose

Mild Cognitive Impairment, Aging

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
digital cognitive training
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Universidade Federal do Rio de JaneiroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Executive Function cognitive training

Games

Arm Description

20 hours of digital cognitive training targeting executive function.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 9, 2019
Last Updated
April 15, 2019
Sponsor
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT03911765
Brief Title
Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)
Official Title
Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
December 2, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Aging

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Stepped wedge
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Executive Function cognitive training
Arm Type
Experimental
Arm Description
20 hours of digital cognitive training targeting executive function.
Arm Title
Games
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
digital cognitive training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Performance in everyday living score change
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Functional status score change
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Global cognitive function score change
Description
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.
Time Frame
3 months
Title
Semantic memory score change
Description
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.
Time Frame
3 months
Title
Selective attention and cognitive flexibility
Description
Selective attention and cognitive flexibility will be measured using the Stroop Test
Time Frame
3 months
Title
Sustained attention and set-shifting
Description
Sustained attention and set-shifting will be measured using the Trial Making Test
Time Frame
3 months
Title
Depression score change
Description
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".
Time Frame
3 months
Title
Qualitative motivation with the computerized training exercise
Description
Qualitative motivation will be assessed using semi-structured interview
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rogério Panizzutti
Phone
21999090498
Ext
55
Email
rpanizzutti@gmail.com
Facility Information:
Facility Name
Universidade Federal do Rio de Janeiro
City
Rio de Janeiro
State/Province
RJ
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rogério Panizzutti, MD, Phd
Phone
5521999090498
Email
rogerio@icb.ufrj.br
First Name & Middle Initial & Last Name & Degree
Aline D'Avila, MSc
Phone
5531987778981
Email
lininha_davila@yahoo.com.br

12. IPD Sharing Statement

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

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