Protocol summary
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Study aim
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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 old community- dwelling elderly in Tehran by controlling the effects of probable variables affecting relationship between cognitive functions and quality of life.
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Design
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The Parallel Group Stratified Randomized Clinical Trial of 52 participants, with blinded analyzer of data enrolled between June 5st to July 21th 2017 and followed for 3 months.
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Settings and conduct
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The subjects were 60-year-old and above people who were selected from three health centers in west of Tehran. Participants were assigned to two groups by health center’s secretary , 26 in the intervention and 26 in the control group.The intervention group attended 12 sessions of a cognitive intervention schedule twice a week. The 45 minute sessions implemented the attentive rehabilitation of attention and the memory (ARAM) software application. the person who analyzed data was blinded.
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Participants/Inclusion and exclusion criteria
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The elderly which obtain the Mini Mental State score of 22 and higher and have no self-report history of psychological or neurodegenerative diseases was entered into the intervention.
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Intervention groups
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The intervention group attended 12 sessions of a cognitive intervention schedule twice a week. The 45 minute sessions implemented the attentive rehabilitation of attention and the memory (ARAM) software application. ARAM is a part of Neurocognitive Joyful Attentive Training Intervention that has been designed as a tool for cognitive rehabilitation.The participants who assigned to the control group were participated in educational workshops about age related cognitive changes and cognitive disorders.
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Main outcome variables
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Primary outcome of the study was Quality of Life which assessed before and three months after the intervention.
General information
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Reason for update
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Entering final results of study and explaining changes which was happen during the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016122731602N1
Registration date:
2017-06-21, 1396/03/31
Registration timing:
registered_while_recruiting
Last update:
2019-12-03, 1398/09/12
Update count:
1
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Registration date
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2017-06-21, 1396/03/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Investigator
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Expected recruitment start date
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2017-06-05, 1396/03/15
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Expected recruitment end date
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2017-07-21, 1396/04/30
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Actual recruitment start date
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2017-06-05, 1396/03/15
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Actual recruitment end date
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2017-07-21, 1396/04/30
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Trial completion date
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2017-10-21, 1396/07/29
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Scientific title
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The impact of computer-based cognitive training intervention on the quality of life among elderly people: A randomized clinical trial
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Public title
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The efficacy of cognitive training intervention on the quality of life of older people
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Eligible participants were older adults aged 60 years and above.
Eligible participants were elderly who were able to communicate in Persian
Older adults required at least four years of education to respond the items on the Mini Mental State Examination (MMSE) test.
Eligible participants achieved a MMSE score ˃21 and a clock drawing test score ≥ 4.
Exclusion criteria:
The diagnoses of a disease which could lead to extreme cognitive or functional decline, such as a stroke in the previous 12 months or end stage cancer
Individuals with dementia and Parkinson disease
Individuals with uncorrected visual or auditory impairment.
Individuals with subjective complaints of memory impairment
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Age
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From 60 years old to 100 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
52
Actual sample size reached:
51
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants were assigned to two groups using Balance blocked randomization, 26 in the intervention and 26 in the control group. Educational level and depression were considered as two potential confounding variables by considering existing evidence .Thus, a stratified randomized design was implemented to control the potentially confounding effect of these two binaries. Four randomizing sequences were used (the combination of depression and low educational level, depression and high educational level, high educational level without depression and low educational level without depression) and the participants were divided in either the intervention or control group based on this different strata. Finally pulled data was analyzed.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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According to the nature of the intervention, the participants could not be blinded in the process of intervention, so the person who analyzed data was blinded to the allocated into the intervention or control groups.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2016-08-10, 1395/05/20
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Ethics committee reference number
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IR.USWR.REC.1395.88
Health conditions studied
1
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Description of health condition studied
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Age-related cognitive decline
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ICD-10 code
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R41.8
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ICD-10 code description
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Other and unspecified symptoms and signs involving cognitive functions and awareness
Primary outcomes
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Description
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Quality of life
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Timepoint
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Before intervention and immediately after intervention and 3 months later
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Method of measurement
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Quality of life questionnaire (SF- 36)
Secondary outcomes
1
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Description
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cognitive function
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Timepoint
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June 5st to July 21th 2017
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Method of measurement
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It was measured basically by the Iranian version of MMSE . The specific domain of the cognitive function was assessed by Wisconsin card sorting test, the Stroop test, the N back test and the go/no-go test
Intervention groups
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for research of University of Social Welfare and Rehabilitation Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available