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Protocol summary
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.
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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 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.
این پژوهش باهدف بررسی تأثیر مداخلات تقویت شناختی مبتنی بر کامپیوتر بر کیفیت زندگی با کنترل اثر متغیرهاي احتمالی موثر بر رابطه ي کارکردهاي شناختی و کیفیت زندگی، در سالمندان بالای 60 سال مقیم جامعه شهر تهران انجام می شود. سالمندانی برای شرکت در مداخله انتخاب می شوند که در آزمون کوتاه وضعیتشناختی نمره 22 و بالاتر کسب کنند و سابقه بیماریهای روانپزشکی و نورودژنراتیو نداشته باشند. حجم نمونه در این مرحله 52 نفر محاسبه شد. روش کار آزمایی بالینی، به شیوه تصادفی سازي شده با طرح طبقه بندي شده است. با توجه به اینکه دو متغیر افسردگی و سطح تحصیلات که به عنوان متغیرهای مخدوشگر در رابطه سطح شناختی و کیفیت زندگی شناخته شدند دو حالتی هستند، چهار جدول رندومیزیشن طراحی می شود و بر اساس آن افراد در دو گروه مداخله و کنترل قرار میگیرند. کورسازی در این مداخله انجام نمی شود. نمونهگیری از سه خانه سلامت وابسته به شهرداری تهران در منطقه غرب شهر انجام میشود. گروه مداخله 12 جلسه تقویت شناختی 45 دقیقهای را توسط نرمافزار کامپیوتری آرام بهصورت دو بار در هفته دریافت میکنند. در انتها کیفیت زندگی به عنوان پیامد اصلی و سطح شناختی افراد مجدداً در قالب پسآزمون، بعد از مداخله و سه ماه بعد سنجیده میشود. گروه کنترل فقط در جلسه اول و آخر ارزیابی میشوند و مداخلهای روی آنها صورت نمیگیرد.
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این پژوهش باهدف بررسی تأثیر مداخلات تقویت شناختی مبتنی بر کامپیوتر بر کیفیت زندگی با کنترل اثر متغیرهاي احتمالی موثر بر رابطه ي کارکردهاي شناختی و کیفیت زندگی، در سالمندان بالای 60 سال مقیم جامعه شهر تهران انجام می شود. سالمندانی برای شرکت در مداخله انتخاب می شوند که در آزمون کوتاه وضعیتشناختی نمره 22 و بالاتر کسب کنند و سابقه بیماریهای روانپزشکی و نورودژنراتیو نداشته باشند. حجم نمونه در این مرحله 52 نفر محاسبه شد. روش کار آزمایی بالینی، به شیوه تصادفی سازي شده با طرح طبقه بندي شده است. با توجه به اینکه دو متغیر افسردگی و سطح تحصیلات که به عنوان متغیرهای مخدوشگر در رابطه سطح شناختی و کیفیت زندگی شناخته شدند دو حالتی هستند، چهار جدول رندومیزیشن طراحی می شود و بر اساس آن افراد در دو گروه مداخله و کنترل قرار میگیرند. کورسازی در این مداخله انجام نمی شود. نمونهگیری از سه خانه سلامت وابسته به شهرداری تهران در منطقه غرب شهر انجام میشود. گروه مداخله 12 جلسه تقویت شناختی 45 دقیقهای را توسط نرمافزار کامپیوتری آرام بهصورت دو بار در هفته دریافت میکنند. در انتها کیفیت زندگی به عنوان پیامد اصلی و سطح شناختی افراد مجدداً در قالب پسآزمون، بعد از مداخله و سه ماه بعد سنجیده میشود. گروه کنترل فقط در جلسه اول و آخر ارزیابی میشوند و مداخلهای روی آنها صورت نمیگیرد.
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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.
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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این پژوهش باهدف بررسی تأثیر مداخلات تقویت شناختی مبتنی بر کامپیوتر بر کیفیت زندگی با کنترل اثر متغیرهاي احتمالی موثر بر رابطه ي کارکردهاي شناختی و کیفیت زندگی، در سالمندان بالای 60 سال مقیم جامعه شهر تهران انجام می شود.
این پژوهش باهدف بررسی تأثیر مداخلات تقویت شناختی مبتنی بر کامپیوتر بر کیفیت زندگی با کنترل اثر متغیرهاي احتمالی موثر بر رابطه ي کارکردهاي شناختی و کیفیت زندگی، در سالمندان بالای 60 سال مقیم جامعه شهر تهران انجام می شود.
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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.
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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کارآزمایی بالینی با گروه های موازی تصادفی شده لایه ای متشکل از 52 شرکت کننده، با کورسازی آنالیزور دیتاها در تاریخ 15 خرداد 1396 تا 30 تیر 1396 اجرا گردید و به مدت 3 ماه پیگیری شد.
کارآزمایی بالینی با گروه های موازی تصادفی شده لایه ای متشکل از 52 شرکت کننده، با کورسازی آنالیزور دیتاها در تاریخ 15 خرداد 1396 تا 30 تیر 1396 اجرا گردید و به مدت 3 ماه پیگیری شد.
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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.
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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افراد دارای سن 60 سال و بالاتر از 3 مرکز سلامت از ناحیه غرب تهران انتخاب شدند. افراد توسط منشی این مراکز به گروه های مداخله و کنترل تقسیم شدند. 26 نفر در گروه مداخله و 26 نفر در گروه کنترل. گروه مداخله به مدت 12 جلسه در مداخلات شناختی به صورت 2 بار در هفته شرکت کردند. جلسات به مدت 45 دقیقه با استفاده از توانبخشی هوشمند حافظه و توجه (آرام) اجرا شد. فردیکه دیتاهای مطالعه را آنالیز می کرد کورسازی شده بود.
افراد دارای سن 60 سال و بالاتر از 3 مرکز سلامت از ناحیه غرب تهران انتخاب شدند. افراد توسط منشی این مراکز به گروه های مداخله و کنترل تقسیم شدند. 26 نفر در گروه مداخله و 26 نفر در گروه کنترل. گروه مداخله به مدت 12 جلسه در مداخلات شناختی به صورت 2 بار در هفته شرکت کردند. جلسات به مدت 45 دقیقه با استفاده از توانبخشی هوشمند حافظه و توجه (آرام) اجرا شد. فردیکه دیتاهای مطالعه را آنالیز می کرد کورسازی شده بود.
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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.
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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سالمندانی برای شرکت در مداخله انتخاب می شوند که در آزمون مختصر وضعیت شناختی نمره 22 و بالاتر کسب کنند و سابقه بیماریهای روانپزشکی و نورودژنراتیو نداشته باشند.
سالمندانی برای شرکت در مداخله انتخاب می شوند که در آزمون مختصر وضعیت شناختی نمره 22 و بالاتر کسب کنند و سابقه بیماریهای روانپزشکی و نورودژنراتیو نداشته باشند.
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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.
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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گروه مداخله در 12 جلسه از مداخلات شناختی به صورت دو بار در هفته حضور یافتند. جلسات به مدت 45 دقیقه با استفاده از نرم افزار توانبخشی شناختی هوشمند حافظه و توجه (آرام) اجرا شد. آرام بخشی از برنامه های مداخالت عصب شناختی هوشمند فرحبخش است که برای توانبخشی شناختی طراحی شده است. شرکت کنندگانی که به گروه کنترل تخصیص داده شده بودند در کارگاه های آموزشی درباره تغییرات شناختی مرتبط با سن و اختلالات شناختی شرکت کردند.
گروه مداخله در 12 جلسه از مداخلات شناختی به صورت دو بار در هفته حضور یافتند. جلسات به مدت 45 دقیقه با استفاده از نرم افزار توانبخشی شناختی هوشمند حافظه و توجه (آرام) اجرا شد. آرام بخشی از برنامه های مداخالت عصب شناختی هوشمند فرحبخش است که برای توانبخشی شناختی طراحی شده است. شرکت کنندگانی که به گروه کنترل تخصیص داده شده بودند در کارگاه های آموزشی درباره تغییرات شناختی مرتبط با سن و اختلالات شناختی شرکت کردند.
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Primary outcome of the study was Quality of Life which assessed before and three months after the intervention.
Primary outcome of the study was Quality of Life which assessed before and three months after the intervention.
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متغیر پیامد اصلی کیفیت زندگی بود. این پیامد قبل و بعد از مداخله و سه ماه بعد از آن ارزیابی شد.
متغیر پیامد اصلی کیفیت زندگی بود. این پیامد قبل و بعد از مداخله و سه ماه بعد از آن ارزیابی شد.
General information
Not blinded
Single blinded
notblsingl
1
1
2
N/A
2na
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51
51
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2017-06-05, 1396/03/15
2017-06-05 00:00:00
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2017-07-21, 1396/04/30
2017-07-21 00:00:00
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2017-10-21, 1396/07/29
2017-10-21 00:00:00
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Entering final results of study and explaining changes which was happen during the study
Entering final results of study and explaining changes which was happen during the study
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ورود اطلاعات نهایی حاصل از مداخله و توضیح تغییرات ایجاد شده در روند مداخله
ورود اطلاعات نهایی حاصل از مداخله و توضیح تغییرات ایجاد شده در روند مداخله
The efficacy of cognitive training intervention on the quality of life of old people
The efficacy of cognitive training intervention on the quality of life of older people
The efficacy of cognitive training intervention on the quality of life of oldolder people
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 impact of computer-based cognitive training intervention on the quality of life among elderly people: A randomized clinical trial
The efficacyimpact of computer-based cognitive training intervention on the quality of life of community- dwellingamong elderly by controlling the effects of probable variables affecting cognitive functions and quality of life relationshippeople: A randomized clinical trial
اثربخشی مداخلات تقویت شناختی مبتنی بر کامپیوتر بر کیفیت زندگی سالمندان مقیم جامعه با کنترل اثر متغیرهای احتمالی موثر بر رابطه ي كاركردهاي شناختي و كيفيت زندگي
اثربخشی مداخلات تقویت شناختی مبتنی بر کامپیوتر بر کیفیت زندگی سالمندان: یک کارآزمایی بالینی تصادفی شده
اثربخشی مداخلات تقویت شناختی مبتنی بر کامپیوتر بر کیفیت زندگی سالمندان مقیم جامعه با کنترل اثر متغیرهای احتمالی موثر بر رابطه ي كاركردهاي شناختي و كيفيت زندگي: یک کارآزمایی بالینی تصادفی شده
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.
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.
افراد واجد شرایط شامل سالمندان بالای 60 سال و بیشتر بودند
افراد واجد شرایط شامل سالمندانی بودند که قادر به صحبت به زبان فارسی بودند
سالمندان دارای حداقل چهار کلاس سواد خواندن و نوشتن تا بتوانند به سوالات آزمون مختصر روانی پاسخ دهند
افرادی که بتوانند در آزمون مختصر روانی حداقل نمره 21 و در آزمون ترسیم ساعت حداقل نمره 4 را کسب کنند.
افراد واجد شرایط شامل سالمندان بالای 60 سال و بیشتر بودند افراد واجد شرایط شامل سالمندانی بودند که قادر به صحبت به زبان فارسی بودند سالمندان دارای حداقل چهار کلاس سواد خواندن و نوشتن تا بتوانند به سوالات آزمون مختصر روانی پاسخ دهند افرادی که بتوانند در آزمون مختصر روانی حداقل نمره 21 و در آزمون ترسیم ساعت حداقل نمره 4 را کسب کنند.
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
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
دارا بودن بیماریهایی که باعث کاهش عملکردی شدید یا مرگ میشوند مانند سابقه استروک در 12 ماه گذشته یا سرطانی که در مراحل پایانی بیماری باشد
سابقه بیماریهایی مانند بیماری پارکینسون و دمانس
نقایص حسی بینایی و شنوایی اصلاحنشده
گزارش خود فرد از بیماری آلزایمر یا شکایت از آسیب های شناختی یا حافظه.
دارا بودن بیماریهایی که باعث کاهش عملکردی شدید یا مرگ میشوند مانند سابقه استروک در 12 ماه گذشته یا سرطانی که در مراحل پایانی بیماری باشد سابقه بیماریهایی مانند بیماری پارکینسون و دمانس نقایص حسی بینایی و شنوایی اصلاحنشده گزارش خود فرد از بیماری آلزایمر یا شکایت از آسیب های شناختی یا حافظه.
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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.
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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شرکت کنندگان توسط تخصیص تصادفی به روش بلوك هاي متغیر به دو گروه مداخله (26 نفر) و کنترل (26 نفر) تقسیم شدند. دو متغیر سطح تحصیلات و افسردگی بر اساس شواهد قبلی به عنوان متغیرهای مخدوشگر در نظر گرفته شدند. سپس طرح تصادفی سازی لایه ای جهت کنترل تاثیر مخدوشگر این دو متغیر به کار گرفته شد. چهار گروه تصادفی در نظر گرفته شد (ترکیبی از افسردگی و سطح تحصیلات پایین، افسردگی و سطح تحصیلات بالا، سطح تحصیلات بالا بدون افسردگی و سطح تحصیلات پایین بدون افسردگی) و شرکت کنندگان بر اساس این لایه ها به دو گروه مداخله و کنترل تقسیم شدند. در نهایت دیتاهای استخراج شده آنالیز شد.
شرکت کنندگان توسط تخصیص تصادفی به روش بلوك هاي متغیر به دو گروه مداخله (26 نفر) و کنترل (26 نفر) تقسیم شدند. دو متغیر سطح تحصیلات و افسردگی بر اساس شواهد قبلی به عنوان متغیرهای مخدوشگر در نظر گرفته شدند. سپس طرح تصادفی سازی لایه ای جهت کنترل تاثیر مخدوشگر این دو متغیر به کار گرفته شد. چهار گروه تصادفی در نظر گرفته شد (ترکیبی از افسردگی و سطح تحصیلات پایین، افسردگی و سطح تحصیلات بالا، سطح تحصیلات بالا بدون افسردگی و سطح تحصیلات پایین بدون افسردگی) و شرکت کنندگان بر اساس این لایه ها به دو گروه مداخله و کنترل تقسیم شدند. در نهایت دیتاهای استخراج شده آنالیز شد.
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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.
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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با توجه به ماهیت مطالعه، امکان کور نگه داشتن شرکت کنندگان در مداخله، در طی فرایند مداخله وجود نداشت، بنابراین فردیکه اطلاعات مطالعه را آنالیز می کرد نسبت به تخصیص افراد به گروه های کنترل و مداخله کور بود.
با توجه به ماهیت مطالعه، امکان کور نگه داشتن شرکت کنندگان در مداخله، در طی فرایند مداخله وجود نداشت، بنابراین فردیکه اطلاعات مطالعه را آنالیز می کرد نسبت به تخصیص افراد به گروه های کنترل و مداخله کور بود.
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Secondary outcomes
#1
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cognitive function
cognitive function
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عملکرد شناختی
عملکرد شناختی
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June 5st to July 21th 2017
June 5st to July 21th 2017
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15 خرداد تا 30 تیر 1396
15 خرداد تا 30 تیر 1396
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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
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
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سطح شناختی اساسا توسط آزمون مختصر وضعیت روانی ارزیابی شد. حیطه های خاص کارکرد شناختی توسط آزمون دسته بندی کارت های ویسکانسین، آزمون استروپ، آزمون ان بک و آزمون برو- نرو ارزیابی شد.
سطح شناختی اساسا توسط آزمون مختصر وضعیت روانی ارزیابی شد. حیطه های خاص کارکرد شناختی توسط آزمون دسته بندی کارت های ویسکانسین، آزمون استروپ، آزمون ان بک و آزمون برو- نرو ارزیابی شد.
Intervention groups
#1
Prevention
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prevention
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.
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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.
گروه کنترل: گروه کنترل فقط در جلسه اول و دوازدهم ارزیابی میشوند و مداخله آموزشی برای آنها انجام نمیشود. پس از پایان کارآزمایی بالینی مداخلات شناختی در گروه کنترل نیز انجام میشود.
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گروه کنترل: گروه کنترل فقط در جلسه اول و دوازدهم ارزیابی میشوند و مداخله آموزشی برای آنها انجام نمیشود. پس از پایان کارآزمایی بالینی مداخلات شناختی در گروه کنترل نیز انجام میشود.
Recruitment centers
#1
Name of recruitment center - English: Ekbatan health center
Name of recruitment center - Persian: سرای محله اکباتان
Full name of responsible person - English: Farzane Mohebi
Full name of responsible person - Persian: فرزانه محبی
Street address - English: Ekbatan health center, Beside Fire Station, Faze 1, Ekbatan.
Street address - Persian: اکباتان، فاز 1، جنب ایستگاه آتش نشانی
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Ekbatan health center
Name of recruitment center - Persian: سرای محله اکباتان
Full name of responsible person - English: Farzane Mohebi
Full name of responsible person - Persian: فرزانه محبی
Street address - English: Ekbatan health center, Beside Fire Station, Faze 1, Ekbatan.
Street address - Persian: اکباتان، فاز 1، جنب ایستگاه آتش نشانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ؟؟؟
Phone: +98 21 4469 4418
Fax:
Email: ekbatan.mytehran@gmail.com
Web page address:
Name of recruitment center - English: Ekbatan health center Name of recruitment center - Persian: سرای محله اکباتان Full name of responsible person - English: Farzane Mohebi Full name of responsible person - Persian: فرزانه محبی Street address - English: Ekbatan health center, Beside Fire Station, Faze 1, Ekbatan. Street address - Persian: اکباتان، فاز 1، جنب ایستگاه آتش نشانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ؟؟؟ Phone: +98 21 4469 4418 Fax: Email: ekbatan.mytehran@gmail.com Web page address:
#2
Name of recruitment center - English: Bimeh health center
Name of recruitment center - Persian: سرای محله بیمه
Full name of responsible person - English: Shadi Jebooie
Full name of responsible person - Persian: شادی جیبویی
Street address - English: Nafisi St, Kooy-e-Bimeh, Ekbatan
Street address - Persian: کوی بیمه، خیابان نفیسی، اکباتان
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Bimeh health center
Name of recruitment center - Persian: سرای محله بیمه
Full name of responsible person - English: Shadi Jebooie
Full name of responsible person - Persian: شادی جیبویی
Street address - English: Nafisi St, Kooy-e-Bimeh, Ekbatan
Street address - Persian: کوی بیمه، خیابان نفیسی، اکباتان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ؟؟؟
Phone: +98 21 4469 3565
Fax:
Email: bimeh.mytehran@gmail.com
Web page address:
Name of recruitment center - English: Bimeh health center Name of recruitment center - Persian: سرای محله بیمه Full name of responsible person - English: Shadi Jebooie Full name of responsible person - Persian: شادی جیبویی Street address - English: Nafisi St, Kooy-e-Bimeh, Ekbatan Street address - Persian: کوی بیمه، خیابان نفیسی، اکباتان City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ؟؟؟ Phone: +98 21 4469 3565 Fax: Email: bimeh.mytehran@gmail.com Web page address:
#3
Name of recruitment center - English: Health center of saadat abad
Name of recruitment center - Persian: سرای محله سعادت آباد
Full name of responsible person - English: Maryam Ghorbani
Full name of responsible person - Persian: مریم قربانی
Street address - English: Shaghayegh Park, Abghari street, Saadat abad
Street address - Persian: سعادت آباد، خیابان عبقری، بوستان شقایق
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Health center of saadat abad
Name of recruitment center - Persian: سرای محله سعادت آباد
Full name of responsible person - English: Maryam Ghorbani
Full name of responsible person - Persian: مریم قربانی
Street address - English: Shaghayegh Park, Abghari street, Saadat abad
Street address - Persian: سعادت آباد، خیابان عبقری، بوستان شقایق
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ؟؟؟
Phone: +98 21 2211 6762
Fax:
Email: maryam.ghorbani@gmail.com
Web page address:
Name of recruitment center - English: Health center of saadat abad Name of recruitment center - Persian: سرای محله سعادت آباد Full name of responsible person - English: Maryam Ghorbani Full name of responsible person - Persian: مریم قربانی Street address - English: Shaghayegh Park, Abghari street, Saadat abad Street address - Persian: سعادت آباد، خیابان عبقری، بوستان شقایق City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ؟؟؟ Phone: +98 21 2211 6762 Fax: Email: maryam.ghorbani@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for research of University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Hamid Reza Khankeh
Full name of responsible person - Persian: دکتر حمیدرضا خانکه
Street address - English: Koodakyar de, Daneshjou Blvd, Evin
Street address - Persian: اوین، بلوار دانشجو ، خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for research of University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Hamid Reza Khankeh
Full name of responsible person - Persian: دکتر حمیدرضا خانکه
Street address - English: Koodakyar de, Daneshjou Blvd, Evin
Street address - Persian: اوین، بلوار دانشجو ، خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713871
Phone: +98 21 2218 0083
Fax:
Email: rd@uswr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice Chancellor for research of University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Hamid Reza Khankeh Full name of responsible person - Persian: دکتر حمیدرضا خانکه Street address - English: Koodakyar de, Daneshjou Blvd, Evin Street address - Persian: اوین، بلوار دانشجو ، خیابان کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985713871 Phone: +98 21 2218 0083 Fax: Email: rd@uswr.ac.ir Web page address:
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Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Leila Kazazi
Full name of responsible person - Persian: لیلا کزازی
Position - English: PhD Student of Gerontology
Position - Persian: دانشجوی دکترای سالمند شناسی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar avenue, Daneshjou Blvd, Evin
Street address - Persian: اوین بلوار دانشجو خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2641 6984
Mobile: +98 912 186 9068
Fax:
Email: Le.kazazi@Uswr.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Leila Kazazi
Full name of responsible person - Persian: لیلا کزازی
Position - English: PhD of Gerontology
Position - Persian: دکترای سالمند شناسی
Latest degree: phd
Area of specialty/work: 52
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar avenue, Daneshjou Blvd, Evin
Street address - Persian: اوین بلوار دانشجو خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2641 6984
Mobile: +98 912 186 9068
Fax:
Email: Le.kazazi@Uswr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Leila Kazazi Full name of responsible person - Persian: لیلا کزازی Position - English: PhD Student of Gerontology Position - Persian: دانشجوی دکترای سالمند شناسی Latest degree: phd Area of specialty/work: 052 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Koodakyar avenue, Daneshjou Blvd, Evin Street address - Persian: اوین بلوار دانشجو خیابان کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 2641 6984 Mobile: +98 912 186 9068 Fax: Email: Le.kazazi@Uswr.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mahshid Froughan
Full name of responsible person - Persian: مهشید فروغان
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar avenue, Daneshjou Blvd, Evin, University of Social Welfare and Rehabilitation Sciences, Gerontology department
Street address - Persian: اوین بلوار دانشجو خیابان کودکیار دانشگاه علوم بهزیستی و توانبخشی ، گروه سالمندی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2218 0004
Mobile: 00
Fax:
Email: m_froughan@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mahshid Froughan
Full name of responsible person - Persian: مهشید فروغان
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 52
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar avenue, Daneshjou Blvd, Evin, University of Social Welfare and Rehabilitation Sciences, Gerontology department
Street address - Persian: اوین بلوار دانشجو خیابان کودکیار دانشگاه علوم بهزیستی و توانبخشی ، گروه سالمندی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2218 0004
Mobile: 00
Fax:
Email: m_froughan@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Mahshid Froughan Full name of responsible person - Persian: مهشید فروغان Position - English: Associate Professor Position - Persian: دانشیار Latest degree: specialist Area of specialty/work: 052 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Koodakyar avenue, Daneshjou Blvd, Evin, University of Social Welfare and Rehabilitation Sciences, Gerontology department Street address - Persian: اوین بلوار دانشجو خیابان کودکیار دانشگاه علوم بهزیستی و توانبخشی ، گروه سالمندی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 2218 0004 Mobile: 00 Fax: Email: m_froughan@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Leila Kazazi
Full name of responsible person - Persian: لیلا کزازی
Position - English: PhD Student of Gerontology
Position - Persian: دانشجوی دکترای سالمند شناسی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar avenue, Daneshjou Blvd, Evin
Street address - Persian: اوین بلوار دانشجو خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2641 6984
Mobile: +98 912 186 9068
Fax:
Email: Leila.kazazi@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Leila Kazazi
Full name of responsible person - Persian: لیلا کزازی
Position - English: PhD of Gerontology
Position - Persian: دکترای سالمند شناسی
Latest degree: phd
Area of specialty/work: 52
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar avenue, Daneshjou Blvd, Evin
Street address - Persian: اوین بلوار دانشجو خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 2641 6984
Mobile: +98 912 186 9068
Fax:
Email: Leila.kazazi@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Leila Kazazi Full name of responsible person - Persian: لیلا کزازی Position - English: PhD Student of Gerontology Position - Persian: دانشجوی دکترای سالمند شناسی Latest degree: phd Area of specialty/work: 052 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Koodakyar avenue, Daneshjou Blvd, Evin Street address - Persian: اوین بلوار دانشجو خیابان کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 2641 6984 Mobile: +98 912 186 9068 Fax: Email: Leila.kazazi@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
no
no
no
no
undecided
undecided
undecided
undecided
undecided
undecided
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there is no more information
there is no more information
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اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Primary outcome of the study was Quality of Life which assessed before and three months after the intervention.
General information
Reason for update
Entering final results of study and explaining changes which was happen during the study
Acronym
IRCT registration information
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
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
2017-06-05, 1396/03/15
Actual recruitment end date
2017-07-21, 1396/04/30
Trial completion date
2017-10-21, 1396/07/29
Scientific title
The impact of computer-based cognitive training intervention on the quality of life among elderly people: A randomized clinical trial
Public title
The efficacy of cognitive training intervention on the quality of life of older people
Purpose
Supportive
Inclusion/Exclusion criteria
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
Age
From 60 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
52
Actual sample size reached:
51
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
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
Province
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
1
Description
cognitive function
Timepoint
June 5st to July 21th 2017
Method of measurement
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
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
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
Province
Tehran
Postal code
؟؟؟
Phone
+98 21 4469 4418
Email
ekbatan.mytehran@gmail.com
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
Province
Tehran
Postal code
؟؟؟
Phone
+98 21 4469 3565
Email
bimeh.mytehran@gmail.com
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
Province
Tehran
Postal code
؟؟؟
Phone
+98 21 2211 6762
Email
maryam.ghorbani@gmail.com
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
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
rd@uswr.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
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 of Gerontology
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Koodakyar avenue, Daneshjou Blvd, Evin
City
Tehran
Province
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
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
Koodakyar avenue, Daneshjou Blvd, Evin, University of Social Welfare and Rehabilitation Sciences, Gerontology department
City
Tehran
Province
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 of Gerontology
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Koodakyar avenue, Daneshjou Blvd, Evin
City
Tehran
Province
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)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available