The efficacy of computer-based cognitive training intervention on the quality of life of community- dwelling elderly by controlling the effects of probable variables affecting cognitive functions and quality of life relationship
The aim of this study is to determine the efficacy of computer-based cognitive training intervention on the quality of life of more than 60 year olds community- dwelling elderly in Tehran by controlling the effects of probable variables affecting relationship between cognitive functions and quality of life. The elderly which obtain the Mini Mental State score of 22 and higher and have no self-report history of psychological or neurodegenerative diseases will enter the intervention. The sample size for this stage was estimated about 52. Considering depression and educational status, which have been known as cofounder variables in relation with cognitive function and quality of life, are dual- state variables, we will design 4 randomization tables and samples will be allocated into intervention and control group based on these variables. No blinding is used in this study. The sampling is done from 3 health centers in the west of Tehran. The intervention group will receive cognitive interventions by ARAM software application through 12 45-minute sessions, twice a week. Finally, quality of life as main outcome and cognitive level will be evaluated through post-test after intervention and 3 months later. The control group will be evaluated in first and last sessions without any intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122731602N1
Registration date:2017-06-21, 1396/03/31
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Leila Kazazi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2641 6984
Email address
le.kazazi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of computer-based cognitive training intervention on the quality of life of community- dwelling elderly by controlling the effects of probable variables affecting cognitive functions and quality of life relationship
Public title
The efficacy of cognitive training intervention on the quality of life of old people
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Older than 60 years old; Mini-Mental State Examination (MMSE) score equal to or more than 22.
Exclusion criteria: Having diseases which lead to extreme functional decline or mortality such as history of stroke in the previous 12 months, or cancer with limited life expectancy and current chemotherapy or radiation treatment; incorrected sensory and auditory impairment; Having recent cognitive training intervention; Major psychiatric illness history including schizophrenia and Bipolar disorder; Major Neurodegenerative illness history including Parkinson disease; Not using medication that harm cognition; Alzheimer’s disease (self-report) or subjective complaints of cognitive or memory impairment.
Age
From 60 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the stratified design randomization will be used. Considering of depression(y/n) and educational status(diploma/academic education) as a dual- state variables, we will design 4 different randomization tables and samples will allocated into intervention and control group based on these variables. Finally data of this tables will be pooling, so we could control the effect of confounder variables.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
Koodakyar de, Daneshjou Blvd, Evin
City
Tehran
Postal code
1985713834
Approval date
2016-08-10, 1395/05/20
Ethics committee reference number
IR.USWR.REC.1395.88
Health conditions studied
1
Description of health condition studied
Age-related cognitive decline
ICD-10 code
R41.8
ICD-10 code description
Other and unspecified symptoms and signs involving cognitive functions and awareness
Primary outcomes
1
Description
Quality of life
Timepoint
Before intervention and immediately after intervention and 3 months later
Method of measurement
Quality of life questionnaire (SF- 36)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In Intervention group, after an evaluation session by assessing with cognitive function and quality of life instruments, participants are trained by ARAM app through 10 45-minute sessions, 2 times per week. Then they will be reassessed in the 12th session. Attentive rehabilitation of attention and memory (ARAM) is a software application that is a part of Neurocognitive Attentive Training Intervention as cognitive rehabilitation intervention. These tasks have different kinds of task in which the level of difficulty are graded and increased based on responses. Grading is based on the number of flanker stimuli, velocity of presented stimuli, number of goal stimuli and changing task rule.
Category
Prevention
2
Description
Control group: control group is evaluated only in the 1st and 12th sessions without any educational intervention. The cognitive intervention will be implemented in control group after accomplishment of clinical trial.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan health center
Full name of responsible person
Farzane Mohebi
Street address
Ekbatan health center, Beside Fire Station, Faze 1, Ekbatan.
City
Tehran
2
Recruitment center
Name of recruitment center
Bimeh health center
Full name of responsible person
Shadi Jebooie
Street address
Nafisi St, Kooy-e-Bimeh, Ekbatan
City
Tehran
3
Recruitment center
Name of recruitment center
Health center of saadat abad
Full name of responsible person
Maryam Ghorbani
Street address
Shaghayegh Park, Abghari street, Saadat abad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Hamid Reza Khankeh
Street address
Koodakyar de, Daneshjou Blvd, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Leila Kazazi
Position
PhD Student of Gerontology
Other areas of specialty/work
Street address
Koodakyar avenue, Daneshjou Blvd, Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2641 6984
Fax
Email
Le.kazazi@Uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mahshid Froughan
Position
Associate Professor
Other areas of specialty/work
Street address
Koodakyar avenue, Daneshjou Blvd, Evin, University of Social Welfare and Rehabilitation Sciences, Gerontology department
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0004
Fax
Email
m_froughan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Leila Kazazi
Position
PhD Student of Gerontology
Other areas of specialty/work
Street address
Koodakyar avenue, Daneshjou Blvd, Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2641 6984
Fax
Email
Leila.kazazi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)