Surveying the effect of a Web-based Health information intervention in care performance, burden, knowledge and attitude of family caregivers of people with dementia in Kerman and evaluation of their satisfaction
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Protocol summary
This study is an interventional study with a control group. The sample size was estimated 25 for each group ( totally 50), according to comparison two mean formula based on previous studies.To select samples, researcher refer the neurologists offices in Kerman city, Iran and samples are select based on inclusion criteria. Then the pre-test will be taken from both groups and after that practitioners are divided into two groups randomly. in next part through designed websites information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care, will be present during 2 months (12 sessions) and in forms of text, slides, pictures and videos. all information approve by a neurologist. After the intervention, post-test comes into action and results will be analyzed using descriptive and inferential statistic.
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This study is an interventional study with a control group. The sample size was estimated 25 for each group ( totally 50), according to comparison two mean formula based on previous studies.To select samples, researcher refer the neurologists offices in Kerman city, Iran and samples are select based on inclusion criteria. Then the pre-test will be taken from both groups and after that practitioners are divided into two groups randomly. in next part through designed websites information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care, will be present during 2 months (12 sessions) and in forms of text, slides, pictures and videos. all information approve by a neurologist. After the intervention, post-test comes into action and results will be analyzed using descriptive and inferential statistic.
اﻳــﻦ ﻣﻄﺎﻟﻌــﻪ ﻳــﻚ ﻣﻄﺎﻟﻌــﻪ مداخله ای با گروه کنترل اﺳﺖ. تعداد نمونه ها بر اساس فرمول مقایسه دو میانگین که از مطالعات قبلی به دست آمده است 25 نفر برای هر گروه ( جمعاً 50 نفر) برآورد شد. برای انتخاب نمونه ها، با مراجعه به پزشکان متخصص مغز و اعصاب شهر کرمان از آنها خواسته خواهد شد تا بیماران مبتلا به آلزایمر مراجعه کننده و دارای پرونده را به پژوهشگر معرفی کنند ﻛﻪ اﺑﺘﺪا ﻧﻤﻮﻧﻪﻫﺎي ﭘﮋوﻫﺶ ﺑﻪ روش ﻧﻤﻮﻧﻪﮔﻴﺮي هدفمند اﻧﺘﺨﺎب می شوند و پیش آزمون از افراد بعمل می آید. پس از آن آزمودنی ها ﺑـــﻪ دو ﮔـــﺮوه مساوی آزمون و ﻛﻨﺘﺮل تقسیم خواهند شد.در مرحله بعد از طریق سایتی که به این منظور طراحی شده است، اطلاعات سلامت مربوط به این بیماری در 12 جلسه در مدت دو ماه به مراقبین ارائه خواهد شد. این اطلاعات بطور عمده در زمینه مفاهیم این بیماری، علائم، تغییرات رفتاری، کنترل استرس مراقبین و نحوه مراقبت ارائه خواهد شد، که تمامی اطلاعات قبل از بارگزاری توسط پزشک متخصص مغز و اعصاب مورد تایید قرار می گیرند. این اطلاعات بصورت متن، اسلاید، معرفی وب سایت های مفید جهت کسب اطلاعات بیشتر، تصاویر و ویدیو ارائه خواهد شد. پس از پایان مداخله، پس آزمون از هر دو گروه بعمل می آید و نتایج با استفاده از آمار توصیفی واستنباطی مورد بررسی و تجزیه و تحلیل قرار خواهد گرفت.
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اﻳــﻦ ﻣﻄﺎﻟﻌــﻪ ﻳــﻚ ﻣﻄﺎﻟﻌــﻪ مداخله ای با گروه کنترل اﺳﺖ. تعداد نمونه ها بر اساس فرمول مقایسه دو میانگین که از مطالعات قبلی به دست آمده است 25 نفر برای هر گروه ( جمعاً 50 نفر) برآورد شد. برای انتخاب نمونه ها، با مراجعه به پزشکان متخصص مغز و اعصاب شهر کرمان از آنها خواسته خواهد شد تا بیماران مبتلا به آلزایمر مراجعه کننده و دارای پرونده را به پژوهشگر معرفی کنند ﻛﻪ اﺑﺘﺪا ﻧﻤﻮﻧﻪﻫﺎي ﭘﮋوﻫﺶ ﺑﻪ روش ﻧﻤﻮﻧﻪﮔﻴﺮي هدفمند اﻧﺘﺨﺎب می شوند و پیش آزمون از افراد بعمل می آید. پس از آن آزمودنی ها ﺑـــﻪ دو ﮔـــﺮوه مساوی آزمون و ﻛﻨﺘﺮل تقسیم خواهند شد.در مرحله بعد از طریق سایتی که به این منظور طراحی شده است، اطلاعات سلامت مربوط به این بیماری در 12 جلسه در مدت دو ماه به مراقبین ارائه خواهد شد. این اطلاعات بطور عمده در زمینه مفاهیم این بیماری، علائم، تغییرات رفتاری، کنترل استرس مراقبین و نحوه مراقبت ارائه خواهد شد، که تمامی اطلاعات قبل از بارگزاری توسط پزشک متخصص مغز و اعصاب مورد تایید قرار می گیرند. این اطلاعات بصورت متن، اسلاید، معرفی وب سایت های مفید جهت کسب اطلاعات بیشتر، تصاویر و ویدیو ارائه خواهد شد. پس از پایان مداخله، پس آزمون از هر دو گروه بعمل می آید و نتایج با استفاده از آمار توصیفی واستنباطی مورد بررسی و تجزیه و تحلیل قرار خواهد گرفت.
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This study aim is evaluating the efficacy of a Web-based health information program for informal caregivers of patients with dementia through a pilot unblinded randomized controlled trial
This study aim is evaluating the efficacy of a Web-based health information program for informal caregivers of patients with dementia through a pilot unblinded randomized controlled trial
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ارزيابي اثربخشی يك برنامه آموزشی بهداشتي مبتني بر وب براي مراقبت كنندگان غيررسمي بيماران مبتلا به زوال عقل بر اساس یک کارآزمایی بالینی تصادفی بدون کورسازی انجام می شود.
ارزيابي اثربخشی يك برنامه آموزشی بهداشتي مبتني بر وب براي مراقبت كنندگان غيررسمي بيماران مبتلا به زوال عقل بر اساس یک کارآزمایی بالینی تصادفی بدون کورسازی انجام می شود.
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randomised trial with control group, unblinded intervention and outcome assessment
randomised trial with control group, unblinded intervention and outcome assessment
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کارآزمایی بالینی تصادفی شده با گروه کنترل، بدون کورسازی و سنجش نتایج
کارآزمایی بالینی تصادفی شده با گروه کنترل، بدون کورسازی و سنجش نتایج
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for selecting participants, researcher refer the neurologists offices in Kerman city, Iran and samples are select based on inclusion criteria. Then the pre-test will be taken from both groups and after that practitioners are divided into two groups randomly. in next part through designed websites information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care, will be present during 2 months (12 sessions) and in forms of text, slides, pictures and videos. all information approve by a neurologist. After the intervention, post-test comes into action and results will be analyzed using descriptive and inferential statistic.
for selecting participants, researcher refer the neurologists offices in Kerman city, Iran and samples are select based on inclusion criteria. Then the pre-test will be taken from both groups and after that practitioners are divided into two groups randomly. in next part through designed websites information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care, will be present during 2 months (12 sessions) and in forms of text, slides, pictures and videos. all information approve by a neurologist. After the intervention, post-test comes into action and results will be analyzed using descriptive and inferential statistic.
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برای انتخاب نمونه ها، با مراجعه به پزشکان متخصص مغز و اعصاب شهر کرمان از آنها خواسته خواهد شد تا بیماران مبتلا به آلزایمر مراجعه کننده و دارای پرونده را به پژوهشگر معرفی کنند ﻛﻪ اﺑﺘﺪا ﻧﻤﻮﻧﻪﻫﺎي ﭘﮋوﻫﺶ ﺑﻪ روش ﻧﻤﻮﻧﻪﮔﻴﺮي هدفمند اﻧﺘﺨﺎب می شوند و پیش آزمون از افراد بعمل می آید. پس از آن آزمودنی ها ﺑـــﻪ دو ﮔـــﺮوه مساوی آزمون و ﻛﻨﺘﺮل تقسیم خواهند شد.در مرحله بعد از طریق سایتی که به این منظور طراحی شده است، اطلاعات سلامت مربوط به این بیماری در 12 جلسه در مدت دو ماه به مراقبین ارائه خواهد شد. این اطلاعات بطور عمده در زمینه مفاهیم این بیماری، علائم، تغییرات رفتاری، کنترل استرس مراقبین و نحوه مراقبت ارائه خواهد شد، که تمامی اطلاعات قبل از بارگزاری توسط پزشک متخصص مغز و اعصاب مورد تایید قرار می گیرند. این اطلاعات بصورت متن، اسلاید، معرفی وب سایت های مفید جهت کسب اطلاعات بیشتر، تصاویر و ویدیو ارائه خواهد شد. پس از پایان مداخله، پس آزمون از هر دو گروه بعمل می آید و نتایج با استفاده از آمار توصیفی واستنباطی مورد بررسی و تجزیه و تحلیل قرار خواهد گرفت.
برای انتخاب نمونه ها، با مراجعه به پزشکان متخصص مغز و اعصاب شهر کرمان از آنها خواسته خواهد شد تا بیماران مبتلا به آلزایمر مراجعه کننده و دارای پرونده را به پژوهشگر معرفی کنند ﻛﻪ اﺑﺘﺪا ﻧﻤﻮﻧﻪﻫﺎي ﭘﮋوﻫﺶ ﺑﻪ روش ﻧﻤﻮﻧﻪﮔﻴﺮي هدفمند اﻧﺘﺨﺎب می شوند و پیش آزمون از افراد بعمل می آید. پس از آن آزمودنی ها ﺑـــﻪ دو ﮔـــﺮوه مساوی آزمون و ﻛﻨﺘﺮل تقسیم خواهند شد.در مرحله بعد از طریق سایتی که به این منظور طراحی شده است، اطلاعات سلامت مربوط به این بیماری در 12 جلسه در مدت دو ماه به مراقبین ارائه خواهد شد. این اطلاعات بطور عمده در زمینه مفاهیم این بیماری، علائم، تغییرات رفتاری، کنترل استرس مراقبین و نحوه مراقبت ارائه خواهد شد، که تمامی اطلاعات قبل از بارگزاری توسط پزشک متخصص مغز و اعصاب مورد تایید قرار می گیرند. این اطلاعات بصورت متن، اسلاید، معرفی وب سایت های مفید جهت کسب اطلاعات بیشتر، تصاویر و ویدیو ارائه خواهد شد. پس از پایان مداخله، پس آزمون از هر دو گروه بعمل می آید و نتایج با استفاده از آمار توصیفی واستنباطی مورد بررسی و تجزیه و تحلیل قرار خواهد گرفت.
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inclusion criteria; personally responsible for patient care (the care was his/her responsibility); to have access to a computer with Internet connection, ability to work with Internet
exclusion criteria: continue participation, assign patient care to other people were our exclusion criteria, and patients death.
inclusion criteria; personally responsible for patient care (the care was his/her responsibility); to have access to a computer with Internet connection, ability to work with Internet exclusion criteria: continue participation, assign patient care to other people were our exclusion criteria, and patients death.
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معیارهای ورود:
وظیفه اصلی مراقبت از بیمار بر عهده آنها باشد
دسترسی به اینترنت و کامپیوتر و توانایی کار با آنها
معیارهای خروج:
عدم تمایل به ادامه همکاری
سپردن مراقبت از بیمار به فرد دیگر
فوت بیمار
معیارهای ورود: وظیفه اصلی مراقبت از بیمار بر عهده آنها باشد دسترسی به اینترنت و کامپیوتر و توانایی کار با آنها معیارهای خروج: عدم تمایل به ادامه همکاری سپردن مراقبت از بیمار به فرد دیگر فوت بیمار
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We recruit and randomize 50 informal caregivers of patients with dementia in Kerman, Iran. They either receive the Web-based intervention and usual care for 2 months (experimental group, n=25) or only usual care (control group, n=25). Caregivers’ perceived knowledge, care burden, attitude and care function were measure at baseline and at the end of the program
We recruit and randomize 50 informal caregivers of patients with dementia in Kerman, Iran. They either receive the Web-based intervention and usual care for 2 months (experimental group, n=25) or only usual care (control group, n=25). Caregivers’ perceived knowledge, care burden, attitude and care function were measure at baseline and at the end of the program
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در این مطالعه 50 مراقب غیررسمی بیماران مبتلا به زوال عقل در کرمان-ایران، انتخاب و به صورت تصادفی به دو گروه آزمون و کنترل تقسیم می شوند. گروه آزمون (25 نفر) مداخله مبتنی بر وب و گروه کنترل(25 نفر) مداخله ای دریافت می کنندو مراقبت معمول و روزانه خود را انجام می دهند. سپس دانش ، بار مراقبتی ، نگرش و عملکرد مراقبت از مراقبان در ابتدا و در پایان برنامه اندازه گیری می شود.
در این مطالعه 50 مراقب غیررسمی بیماران مبتلا به زوال عقل در کرمان-ایران، انتخاب و به صورت تصادفی به دو گروه آزمون و کنترل تقسیم می شوند. گروه آزمون (25 نفر) مداخله مبتنی بر وب و گروه کنترل(25 نفر) مداخله ای دریافت می کنندو مراقبت معمول و روزانه خود را انجام می دهند. سپس دانش ، بار مراقبتی ، نگرش و عملکرد مراقبت از مراقبان در ابتدا و در پایان برنامه اندازه گیری می شود.
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knowledge
care burden
attitude
care function
knowledge care burden attitude care function
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دانش
بار مراقبتی
نگرش
عملکرد مراقبتی
دانش بار مراقبتی نگرش عملکرد مراقبتی
General information
Double blinded
Not blinded
doublnotbl
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50
50
2017-02-19, 1395/12/01
2017-05-22, 1396/03/01
2017-0205-1922 00:00:00
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2016-11-21, 1395/09/01
2016-11-21 00:00:00
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2017-05-22, 1396/03/01
2017-05-22 00:00:00
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2017-11-11, 1396/08/20
2017-11-11 00:00:00
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this trial updating because:
1- update the sampling date: The sampling took longer than originally mentioned due to the drop in the number of samples before starting the intervention. because most of them canceled their cooperation.
2- double blinded changed to un blinded because double blinded did not apply in web interevention.
this trial updating because: 1- update the sampling date: The sampling took longer than originally mentioned due to the drop in the number of samples before starting the intervention. because most of them canceled their cooperation. 2- double blinded changed to un blinded because double blinded did not apply in web interevention.
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دلیل اول بروز رسانی تاریخ نمونه گیری بود. نمونه گیری بیشتر از تاریخی که در ابتدا ذکر شده بود به طول انجامید که یکی از این دلایل آن ناکافی بودن نمونه ها برای شروع مطالعه بود زیرا بسیاری از آنها پیش از شروع کار از همکاری منصرف شدند بنابراین نمونه گیری ادامه یافت.
دلیل دوم پس از شروع کار با توجه به نوع کار تصمیم گرفته شد مداخله بدون کورسازی انجام شود که این مورد نیز اصلاح گردید.
دلیل اول بروز رسانی تاریخ نمونه گیری بود. نمونه گیری بیشتر از تاریخی که در ابتدا ذکر شده بود به طول انجامید که یکی از این دلایل آن ناکافی بودن نمونه ها برای شروع مطالعه بود زیرا بسیاری از آنها پیش از شروع کار از همکاری منصرف شدند بنابراین نمونه گیری ادامه یافت. دلیل دوم پس از شروع کار با توجه به نوع کار تصمیم گرفته شد مداخله بدون کورسازی انجام شود که این مورد نیز اصلاح گردید.
nclusion criteria: consent to participate in research; caregiver is personally responsible for patient care (the care of his responsibility); internet access (at least twice a week); understanding and ability to work with Internet; interested in receiving information on this disease.
Exclusion criteria: unwillingness to continue to cooperate; escrow patient care to other people; patient death.
nclusion criteria: consent to participate in research; caregiver is personally responsible for patient care (the care of his responsibility); internet access (at least twice a week); understanding and ability to work with Internet; interested in receiving information on this disease. Exclusion criteria: unwillingness to continue to cooperate; escrow patient care to other people; patient death.
ضایت برای مشارکت در تحقیق • فرد مراقبت شخصاً مراقبت از بیمار را بر عهده داشته باشد( عمده مسئولیت مراقبت بر عهده او باشد) • دسترسی به اینترنت (حداقل دو بار در هفته) • آشنایی و توانایی کار با اینترنت • علاقمند به دریافت اطلاعات در زمینه این بیماری
معیارهای خروج: • عدم تمایل به ادامه همکاری • سپردن مراقبت از بیمار به افراد دیگر • فوت بیمار
ضایت برای مشارکت در تحقیق • فرد مراقبت شخصاً مراقبت از بیمار را بر عهده داشته باشد( عمده مسئولیت مراقبت بر عهده او باشد) • دسترسی به اینترنت (حداقل دو بار در هفته) • آشنایی و توانایی کار با اینترنت • علاقمند به دریافت اطلاعات در زمینه این بیماری معیارهای خروج: • عدم تمایل به ادامه همکاری • سپردن مراقبت از بیمار به افراد دیگر • فوت بیمار
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In this study, the Stratified randomization method was used. By attempting to eliminate heterogeneity of the groups before random allocation by classifying two variables; age and the number of hours in day caring for care recipient
In this study, the Stratified randomization method was used. By attempting to eliminate heterogeneity of the groups before random allocation by classifying two variables; age and the number of hours in day caring for care recipient
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در این مطالعه از روش تصادفی سازی طبقه بندی استفاده شده است.
که با طبقه بندی بر روی متغیرهای سن و تعداد ساعات مراقبت در روز ، سعی در حذف ناهمگنی گروه ها پیش از تخصیص تصادفی شده است.
در این مطالعه از روش تصادفی سازی طبقه بندی استفاده شده است. که با طبقه بندی بر روی متغیرهای سن و تعداد ساعات مراقبت در روز ، سعی در حذف ناهمگنی گروه ها پیش از تخصیص تصادفی شده است.
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Recruitment centers
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Name of recruitment center - English: Neurologists office
Name of recruitment center - Persian: مطب پزشکان متخصص مغز و اعصاب
Full name of responsible person - English: Neurology Specialist
Full name of responsible person - Persian: پزشک متخصص مغز و اعصاب
Street address - English:
Street address - Persian:
City - English: Kerman
City - Persian: کرمان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Neurologists office
Name of recruitment center - Persian: مطب پزشکان متخصص مغز و اعصاب
Full name of responsible person - English: Neurology Specialist
Full name of responsible person - Persian: پزشک متخصص مغز و اعصاب
Street address - English: haft bagh highway
Street address - Persian: بزرگراه هفت باغ
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616911320
Phone: +98 34 3132 5406
Fax:
Email: mirc.kmu@gmail.com
Web page address:
Name of recruitment center - English: Neurologists office Name of recruitment center - Persian: مطب پزشکان متخصص مغز و اعصاب Full name of responsible person - English: Neurology Specialist Full name of responsible person - Persian: پزشک متخصص مغز و اعصاب Street address - English: haft bagh highway Street address - Persian: بزرگراه هفت باغ City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7616911320 Phone: +98 34 3132 5406 Fax: Email: mirc.kmu@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor for Research, Kerman, University of Medical Sciences
Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمان
Full name of responsible person - English: Dr. Abbas Pardakhti
Full name of responsible person - Persian: دکتر عباس پرداختی- معاون پژوهشی
Street address - English: Somayeh intersection, In front of the Besaat clinic
Street address - Persian: چهارراه سمیه- روبروی کلینیک بعثت
City - English: Kerman
City - Persian: کرمان
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, Kerman, University of Medical Sciences
Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمان
Full name of responsible person - English: Dr. Abbas Pardakhti
Full name of responsible person - Persian: دکتر عباس پرداختی- معاون پژوهشی
Street address - English: Somayeh intersection, In front of the Besaat clinic
Street address - Persian: چهارراه سمیه- روبروی کلینیک بعثت
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7619813159
Phone: +98 34 3226 3878
Fax:
Email: kmu_research@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice Chancellor for Research, Kerman, University of Medical Sciences Name of organization / entity - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی کرمان Full name of responsible person - English: Dr. Abbas Pardakhti Full name of responsible person - Persian: دکتر عباس پرداختی- معاون پژوهشی Street address - English: Somayeh intersection, In front of the Besaat clinic Street address - Persian: چهارراه سمیه- روبروی کلینیک بعثت City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7619813159 Phone: +98 34 3226 3878 Fax: Email: kmu_research@yahoo.com Web page address:
empty
100
100
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
#2
contact.organization_id:
Name of organization / entity - English: Medical Informatics Resaerch Center
Name of organization / entity - Persian: مرکز تحقیقات انفورماتیک پزشکی
Full name of responsible person - English: Dr. Reza Khajouei
Full name of responsible person - Persian: دکتر ر ضا خواجوئی
Street address - English: Unit 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway
Street address - Persian: بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان،پژوهشکده آینده پژوهی در سلامت، طبقه دوم، واحد 212
City - English: Kerman
City - Persian: کرمان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Medical Informatics Resaerch Center
Name of organization / entity - Persian: مرکز تحقیقات انفورماتیک پزشکی
Full name of responsible person - English: Dr. Reza Khajouei
Full name of responsible person - Persian: دکتر ر ضا خواجوئی
Street address - English: Unit 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway
Street address - Persian: بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان،پژوهشکده آینده پژوهی در سلامت، طبقه دوم، واحد 212
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7616911320
Phone: +98 34 3132 5406
Fax:
Email: mirc.kmu@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Medical Informatics Resaerch Center Name of organization / entity - Persian: مرکز تحقیقات انفورماتیک پزشکی Full name of responsible person - English: Dr. Reza Khajouei Full name of responsible person - Persian: دکتر ر ضا خواجوئی Street address - English: Unit 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway Street address - Persian: بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان،پژوهشکده آینده پژوهی در سلامت، طبقه دوم، واحد 212 City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7616911320 Phone: +98 34 3132 5406 Fax: Email: mirc.kmu@gmail.com Web page address:
empty
100
100
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Kerman Medical Informatics Resaerch Center
Name of organization / entity - Persian: مرکز تحقیقات انفورماتیک پزشکی
Full name of responsible person - English: Simin Salehi Nejad
Full name of responsible person - Persian: سیمین صالحی نژاد
Position - English: MS.c
Position - Persian: کارشناسی ارشد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran
Street address - Persian: کرمان،بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان،پژوهشکده آینده پژوهی در سلامت، طبقه دوم، واحد 212
City - English: Kerman
City - Persian: کرمان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: Iran
Phone: +98 34 3132 5418
Mobile:
Fax:
Email: s_salehinejad@yahoo.com; s_salehi@kmu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Kerman Medical Informatics Resaerch Center
Name of organization / entity - Persian: مرکز تحقیقات انفورماتیک پزشکی
Full name of responsible person - English: Simin Salehi Nejad
Full name of responsible person - Persian: سیمین صالحی نژاد
Position - English: MS.c
Position - Persian: کارشناسی ارشد
Latest degree: master
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran
Street address - Persian: کرمان،بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان،پژوهشکده آینده پژوهی در سلامت، طبقه دوم، واحد 212
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: Iran
Phone: +98 34 3132 5418
Mobile: 0098913298832
Fax:
Email: s_salehi@kmu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kerman Medical Informatics Resaerch Center Name of organization / entity - Persian: مرکز تحقیقات انفورماتیک پزشکی Full name of responsible person - English: Simin Salehi Nejad Full name of responsible person - Persian: سیمین صالحی نژاد Position - English: MS.c Position - Persian: کارشناسی ارشد Latest degree: master Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran Street address - Persian: کرمان،بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان،پژوهشکده آینده پژوهی در سلامت، طبقه دوم، واحد 212 City - English: Kerman City - Persian: کرمان Province: Kerman Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: Iran Phone: +98 34 3132 5418 Mobile: 0098913298832 Fax: Email: s_salehinejad@yahoo.com; s_salehi@kmu.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kerman Faculty of Management and Health Informatics
Name of organization / entity - Persian: دانشکده مدیریت و اطلاع رسانی پزشکی
Full name of responsible person - English: Mohammad Aazami
Full name of responsible person - Persian: دکتر محمد اعظمی
Position - English: Ph.D of library and information sciences
Position - Persian: دکترای کتابداری و اطلاع رسانی پزشکی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Faculty of Management and Health Informatics, Kerman University of Medical Sciences, Haft Baghe Alavi Highway
Street address - Persian: کرمان،بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان، دانشکده مدیریت و اطلاع رسانی پزشکی
City - English: Kerman
City - Persian: کرمان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: Iran
Phone: +98 34 3132 5394
Mobile:
Fax:
Email: mohammadaazami14@gmail.com; m_azami@kmu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Kerman Faculty of Management and Health Informatics
Name of organization / entity - Persian: دانشکده مدیریت و اطلاع رسانی پزشکی
Full name of responsible person - English: Mohammad Aazami
Full name of responsible person - Persian: دکتر محمد اعظمی
Position - English: Ph.D of library and information sciences
Position - Persian: دکترای کتابداری و اطلاع رسانی پزشکی
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English: medical librarian and information sciences
Area of specialty/work title - Persian: کتابداری و اطلاع رسانی پزشکی
Street address - English: Faculty of Management and Health Informatics, Kerman University of Medical Sciences, Haft Baghe Alavi Highway
Street address - Persian: کرمان،بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان، دانشکده مدیریت و اطلاع رسانی پزشکی
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: Iran
Phone: +98 34 3132 5394
Mobile: +98 913 395 6476
Fax:
Email: mohammadaazami14@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Kerman Faculty of Management and Health Informatics Name of organization / entity - Persian: دانشکده مدیریت و اطلاع رسانی پزشکی Full name of responsible person - English: Mohammad Aazami Full name of responsible person - Persian: دکتر محمد اعظمی Position - English: Ph.D of library and information sciences Position - Persian: دکترای کتابداری و اطلاع رسانی پزشکی Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: medical librarian and information sciences Area of specialty/work title - Persian: کتابداری و اطلاع رسانی پزشکی Street address - English: Faculty of Management and Health Informatics, Kerman University of Medical Sciences, Haft Baghe Alavi Highway Street address - Persian: کرمان،بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان، دانشکده مدیریت و اطلاع رسانی پزشکی City - English: Kerman City - Persian: کرمان Province: Kerman Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: Iran Phone: +98 34 3132 5394 Mobile: +98 913 395 6476 Fax: Email: mohammadaazami14@gmail.com; m_azami@kmu.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kerman Medical Informatics Resaerch Center
Name of organization / entity - Persian: مرکز تحقیقات انفورماتیک پزشکی
Full name of responsible person - English: Simin Salehi Nejad
Full name of responsible person - Persian: سیمین صالحی نژاد
Position - English: MS.c
Position - Persian: کارشناسی ارشد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran
Street address - Persian: کرمان،بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان،پژوهشکده آینده پژوهی در سلامت، طبقه دوم، واحد 212
City - English: Kerman
City - Persian: کرمان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: Iran
Phone: +98 34 3132 5418
Mobile: +98 913 297 8832
Fax:
Email: s_salehinejad@yahoo.com; s_salehi@kmu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Kerman Medical Informatics Resaerch Center
Name of organization / entity - Persian: مرکز تحقیقات انفورماتیک پزشکی
Full name of responsible person - English: Simin Salehi Nejad
Full name of responsible person - Persian: سیمین صالحی نژاد
Position - English: MS.c
Position - Persian: کارشناسی ارشد
Latest degree: master
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran
Street address - Persian: کرمان،بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان،پژوهشکده آینده پژوهی در سلامت، طبقه دوم، واحد 212
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: Iran
Phone: +98 34 3132 5418
Mobile: +98 913 297 8832
Fax:
Email: s_salehi@kmu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kerman Medical Informatics Resaerch Center Name of organization / entity - Persian: مرکز تحقیقات انفورماتیک پزشکی Full name of responsible person - English: Simin Salehi Nejad Full name of responsible person - Persian: سیمین صالحی نژاد Position - English: MS.c Position - Persian: کارشناسی ارشد Latest degree: master Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran Street address - Persian: کرمان،بزرگراه هفت باغ، پردیزه دانشگاه علوم پزشکی کرمان،پژوهشکده آینده پژوهی در سلامت، طبقه دوم، واحد 212 City - English: Kerman City - Persian: کرمان Province: Kerman Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: Iran Phone: +98 34 3132 5418 Mobile: +98 913 297 8832 Fax: Email: s_salehinejad@yahoo.com; s_salehi@kmu.ac.ir Web page address:
Sharing plan
yes
yes
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
the primary outcome measure only
the primary outcome measure only
empty
اطلاعات مربوط به پیامد اصلی
اطلاعات مربوط به پیامد اصلی
empty
starting results 6 months after publication
starting results 6 months after publication
empty
شروع دوره دسترسی 6 ماه پس از چاپ نتایج
شروع دوره دسترسی 6 ماه پس از چاپ نتایج
empty
Patient and caregiver data will not be available for anybody
Patient and caregiver data will not be available for anybody
empty
داده های بیماران و مراقبین در دسترس قرار نخواهد گرفت
داده های بیماران و مراقبین در دسترس قرار نخواهد گرفت
empty
Only use the results of the study in future studies
Only use the results of the study in future studies
empty
تنها اجازه استفاده از نتایج مطالعه در مطالعات بعدی
تنها اجازه استفاده از نتایج مطالعه در مطالعات بعدی
empty
email: s_salehi@kmu.ac.ir
email: s_salehi@kmu.ac.ir
empty
از طریق ایمیلs_salehi@kmu.ac.ir
از طریق ایمیلs_salehi@kmu.ac.ir
empty
Undecided
Undecided
empty
تصمیمی گرفته نشده
تصمیمی گرفته نشده
Protocol summary
Study aim
This study aim is evaluating the efficacy of a Web-based health information program for informal caregivers of patients with dementia through a pilot unblinded randomized controlled trial
Design
randomised trial with control group, unblinded intervention and outcome assessment
Settings and conduct
for selecting participants, researcher refer the neurologists offices in Kerman city, Iran and samples are select based on inclusion criteria. Then the pre-test will be taken from both groups and after that practitioners are divided into two groups randomly. in next part through designed websites information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care, will be present during 2 months (12 sessions) and in forms of text, slides, pictures and videos. all information approve by a neurologist. After the intervention, post-test comes into action and results will be analyzed using descriptive and inferential statistic.
Participants/Inclusion and exclusion criteria
inclusion criteria; personally responsible for patient care (the care was his/her responsibility); to have access to a computer with Internet connection, ability to work with Internet
exclusion criteria: continue participation, assign patient care to other people were our exclusion criteria, and patients death.
Intervention groups
We recruit and randomize 50 informal caregivers of patients with dementia in Kerman, Iran. They either receive the Web-based intervention and usual care for 2 months (experimental group, n=25) or only usual care (control group, n=25). Caregivers’ perceived knowledge, care burden, attitude and care function were measure at baseline and at the end of the program
Main outcome variables
knowledge
care burden
attitude
care function
General information
Reason for update
this trial updating because:
1- update the sampling date: The sampling took longer than originally mentioned due to the drop in the number of samples before starting the intervention. because most of them canceled their cooperation.
2- double blinded changed to un blinded because double blinded did not apply in web interevention.
Acronym
IRCT registration information
IRCT registration number:IRCT2016052828121N1
Registration date:2017-02-26, 1395/12/08
Registration timing:registered_while_recruiting
Last update:2019-12-31, 1398/10/10
Update count:1
Registration date
2017-02-26, 1395/12/08
Registrant information
Name
Simin Salehi Nejad
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5418
Email address
s_salehi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kerman University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-05-22, 1396/03/01
Trial completion date
2017-11-11, 1396/08/20
Scientific title
Surveying the effect of a Web-based Health information intervention in care performance, burden, knowledge and attitude of family caregivers of people with dementia in Kerman and evaluation of their satisfaction
Public title
Effect of information intervention in care performance, burden, knowledge and attitude of family caregivers of people with dementia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
nclusion criteria: consent to participate in research; caregiver is personally responsible for patient care (the care of his responsibility); internet access (at least twice a week); understanding and ability to work with Internet; interested in receiving information on this disease.
Exclusion criteria: unwillingness to continue to cooperate; escrow patient care to other people; patient death.
Exclusion criteria:
Age
From 15 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Stratified randomization method was used. By attempting to eliminate heterogeneity of the groups before random allocation by classifying two variables; age and the number of hours in day caring for care recipient
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Somayeh intersection, In front of the Besaat clinic,
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2016-08-20, 1395/05/30
Ethics committee reference number
IR.KMU.REC.1395.185
Health conditions studied
1
Description of health condition studied
Dementia in Alzheimer disease
ICD-10 code
F00
ICD-10 code description
Alzheimer disease is a primary degenerative cerebral disease of unknown etiology with characteristic neuropathological and neurochemical features. The disorder is usually insidious in onset and develops slowly but steadily over a period of several years
2
Description of health condition studied
Vascular dementia
ICD-10 code
F01
ICD-10 code description
Vascular dementia is the result of infarction of the brain due to vascular disease, including hypertensive cerebrovascular disease. The infarcts are usually small but cumulative in their effect. Onset is usually in later life
3
Description of health condition studied
Dementia in other diseases classified elsewhere
ICD-10 code
F02
ICD-10 code description
Cases of dementia due, or presumed to be due, to causes other than Alzheimer disease or cerebrovascular disease. Onset may be at any time in life, though rarely in old age
Primary outcomes
1
Description
Care burden
Timepoint
At the begining and 2 months after intervention
Method of measurement
Questionnaire
2
Description
Care performance
Timepoint
At the begining and 2 months after intervention
Method of measurement
Questionnaire
3
Description
Knowledge
Timepoint
At the begining and 2 months after intervention
Method of measurement
Questionnaire
4
Description
Attitude
Timepoint
At the begining and 2 months after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Through designed websites information mainly on the implications of this disease, its symptoms, behavioral changes, stress management for caregivers and how to take care will be present during 2 months (12 sessions) and in forms of text, slides, pictures and video all information which approved by a neurologist.
Category
Other
2
Description
The participants of control group received no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurologists office
Full name of responsible person
Neurology Specialist
Street address
haft bagh highway
City
Kerman
Province
Kerman
Postal code
7616911320
Phone
+98 34 3132 5406
Email
mirc.kmu@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Kerman, University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Somayeh intersection, In front of the Besaat clinic
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3878
Email
kmu_research@yahoo.com
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, Kerman, University of Medical 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
2
Sponsor
Name of organization / entity
Medical Informatics Resaerch Center
Full name of responsible person
Dr. Reza Khajouei
Street address
Unit 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway
City
Kerman
Province
Kerman
Postal code
7616911320
Phone
+98 34 3132 5406
Email
mirc.kmu@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Informatics Resaerch Center
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
Kerman Medical Informatics Resaerch Center
Full name of responsible person
Simin Salehi Nejad
Position
MS.c
Latest degree
Master
Other areas of specialty/work
Street address
No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
Iran
Phone
+98 34 3132 5418
Fax
Email
s_salehi@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Faculty of Management and Health Informatics
Full name of responsible person
Mohammad Aazami
Position
Ph.D of library and information sciences
Latest degree
Ph.D.
Other areas of specialty/work
medical librarian and information sciences
Street address
Faculty of Management and Health Informatics, Kerman University of Medical Sciences, Haft Baghe Alavi Highway
City
Kerman
Province
Kerman
Postal code
Iran
Phone
+98 34 3132 5394
Fax
Email
mohammadaazami14@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman Medical Informatics Resaerch Center
Full name of responsible person
Simin Salehi Nejad
Position
MS.c
Latest degree
Master
Other areas of specialty/work
Street address
No. 212, 2nd floor, Institute for Future Studies in Health, Kerman University of Medical Sciences, Haft Baghe Alavi Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
Iran
Phone
+98 34 3132 5418
Fax
Email
s_salehi@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Title and more details about the data/document
the primary outcome measure only
When the data will become available and for how long
starting results 6 months after publication
To whom data/document is available
Patient and caregiver data will not be available for anybody
Under which criteria data/document could be used
Only use the results of the study in future studies
From where data/document is obtainable
email: s_salehi@kmu.ac.ir
What processes are involved for a request to access data/document