Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
A randomized, double-blind, placebo-controlled clinical trial with a sample size of 35 in each group
A prospective, randomized, open-label, routine care–controlled trial with a sample size of 35 in each group.
A prospective, randomized, doubleopen-blindlabel, placebo-routine care–controlled clinical trial with a sample size of 35 in each group.
کارآزمایی بالینی دارای گروه کنترل با روش نمونه گیری در دسترس، تصادفی شده، دو سویه کور با حجم نمونه ی 35 نفر در هر گروه
کارآزمایی بالینی تصادفی‌شده، آینده‌نگر، بدون کورسازی (باز)، با گروه کنترل دریافت‌کننده مراقبت معمول، با حجم نمونه ۳۵ نفر در هر گروه
کارآزمایی بالینی دارایتصادفیشده، آینده‌نگر، بدون کورسازی (باز)، با گروه کنترل با روش نمونه گیری در دسترسدریافتکننده مراقبت معمول، تصادفی شده، دو سویه کور با حجم نمونه ی 35۳۵ نفر در هر گروه
In this study, after determining the sample size, sampling will be done by available method and patients will be randomly assigned to two groups. In the experimental group, self-efficacy program with usual care is offered to hemodialysis patients and in the control group routine care is performed. The program will be run through six sessions, with the creation of a WhatsApp or Telegram group, which will include a self-efficacy training program.
In this study, after determining the sample size, sampling will be done by available method and patients will be randomly assigned to two groups. In the experimental group, a self-efficacy program in addition to usual care is offered to hemodialysis patients, and in the control group only routine care is provided. The program will be run through 12 sessions, delivered over a period of 6 to 12 weeks, through the creation of a WhatsApp or Telegram group, which will include a self-efficacy training program.
In this study, after determining the sample size, sampling will be done by available method and patients will be randomly assigned to two groups. In the experimental group, a self-efficacy program within addition to usual care is offered to hemodialysis patients, and in the control group only routine care is performedprovided. The program will be run through six12 sessions, withdelivered over a period of 6 to 12 weeks, through the creation of a WhatsApp or Telegram group, which will include a self-efficacy training program.
در این مطالعه پس از تعیین حجم نمونه، نمونه گیری به روش در دسترس انجام خواهد شد و بیماران به صورت تصادفی به دو گروه تخصیص داده خواهند شد. در گروه آزمون برنامه خودکارآمدی همراه با مراقبت های معمول به بیماران همودیالیزی ارائه شده و در گروه کنترل نیز مراقبت های معمول اجرا می شوند. این برنامه از طریق ایجاد گروه در فضای مجازی واتس آپ یا تلگرام در طی شش جلسه اجرا خواهد شد که شامل برنامه ی آموزشی ارتقاء خودکارآمدی می باشد.
در این مطالعه پس از تعیین حجم نمونه، نمونه‌گیری به روش در دسترس انجام خواهد شد و بیماران به‌صورت تصادفی به دو گروه تخصیص داده خواهند شد. در گروه آزمون، برنامه خودکارآمدی همراه با مراقبت‌های معمول به بیماران همودیالیزی ارائه شده و در گروه کنترل نیز فقط مراقبت‌های معمول اجرا می‌شوند. این برنامه از طریق ایجاد گروه خودکارآمدی در فضای مجازی واتس‌آپ یا تلگرام، در طی ۱۲ جلسه و طی مدت ۶ تا ۱۲ هفته اجرا خواهد شد که شامل برنامه‌ی آموزشی ارتقاء می‌باشد.
در این مطالعه پس از تعیین حجم نمونه، نمونه‌گیری به روش در دسترس انجام خواهد شد و بیماران به‌صورت تصادفی به دو گروه تخصیص داده خواهند شد. در گروه آزمون، برنامه خودکارآمدی همراه با مراقبت‌های معمول به بیماران همودیالیزی ارائه شده و در گروه کنترل نیز فقط مراقبت‌های معمول اجرا می‌شوند. این برنامه از طریق ایجاد گروه خودکارآمدی در فضای مجازی واتس‌آپ یا تلگرام، در طی شش۱۲ جلسه و طی مدت ۶ تا ۱۲ هفته اجرا خواهد شد که شامل برنامه‌ی آموزشی ارتقاء خودکارآمدی می‌باشد.
General information
empty
61
61
empty
2020-02-20, 1398/12/01
2020-02-20 00:00:00
empty
2020-04-19, 1399/01/31
2020-04-19 00:00:00
empty
2020-07-21, 1399/04/31
2020-07-21 00:00:00
empty
This update includes:
1. Completion of the previously empty "Actual recruitment start/end date" and "Trial completion date" fields, based on the actual study timeline.
2. Addition of contact information for six additional recruitment centers (beyond the originally registered center) that participated in the actual conduct of the study.
3. Correction of the study design description in the protocol summary from "double-blind/placebo-controlled" to "open-label/routine care-controlled," consistent with the actual methodology.
4. Correction of the number of intervention sessions from 6 to 12, consistent with the approved proposal and protocol.
5. Correction of the number of intervention sessions from 6 to 12 in the "Intervention Groups" section (consistent with the approved proposal and protocol), and reclassification of the intervention type for both groups from "other" to "behavioral."
This update includes: 1. Completion of the previously empty "Actual recruitment start/end date" and "Trial completion date" fields, based on the actual study timeline. 2. Addition of contact information for six additional recruitment centers (beyond the originally registered center) that participated in the actual conduct of the study. 3. Correction of the study design description in the protocol summary from "double-blind/placebo-controlled" to "open-label/routine care-controlled," consistent with the actual methodology. 4. Correction of the number of intervention sessions from 6 to 12, consistent with the approved proposal and protocol. 5. Correction of the number of intervention sessions from 6 to 12 in the "Intervention Groups" section (consistent with the approved proposal and protocol), and reclassification of the intervention type for both groups from "other" to "behavioral."
empty
این بروزرسانی شامل موارد زیر است:
۱. تکمیل «تاریخ شروع/پایان بیمارگیری تحقق‌یافته» و «تاریخ خاتمه کارآزمایی» که پیش‌تر خالی بودند، بر اساس بازه‌ی واقعی اجرای مطالعه.
۲. افزودن اطلاعات تماس شش مرکز بیمارگیری دیگر (علاوه بر مرکز ثبت‌شده‌ی اولیه) که در اجرای واقعی مطالعه مشارکت داشتند.
۳. اصلاح توصیف نوع مطالعه در چکیده پروتکل از «دوسوکور/دارونما-کنترل» به «باز (بدون کورسازی)/مراقبت معمول-کنترل»، منطبق با روش واقعی اجرا.
۴. اصلاح تعداد جلسات برنامه مداخله از ۶ به ۱۲ جلسه، منطبق با پروپوزال و پروتکل مصوب.
۵. اصلاح تعداد جلسات برنامه مداخله از ۶ به ۱۲ جلسه در بخش «گروه‌های مداخله» (منطبق با پروپوزال و پروتکل مصوب)، و تغییر «طبقه‌بندی» مداخله در هر دو گروه از «other» به «رفتاری».
این بروزرسانی شامل موارد زیر است: ۱. تکمیل «تاریخ شروع/پایان بیمارگیری تحقق‌یافته» و «تاریخ خاتمه کارآزمایی» که پیش‌تر خالی بودند، بر اساس بازه‌ی واقعی اجرای مطالعه. ۲. افزودن اطلاعات تماس شش مرکز بیمارگیری دیگر (علاوه بر مرکز ثبت‌شده‌ی اولیه) که در اجرای واقعی مطالعه مشارکت داشتند. ۳. اصلاح توصیف نوع مطالعه در چکیده پروتکل از «دوسوکور/دارونما-کنترل» به «باز (بدون کورسازی)/مراقبت معمول-کنترل»، منطبق با روش واقعی اجرا. ۴. اصلاح تعداد جلسات برنامه مداخله از ۶ به ۱۲ جلسه، منطبق با پروپوزال و پروتکل مصوب. ۵. اصلاح تعداد جلسات برنامه مداخله از ۶ به ۱۲ جلسه در بخش «گروه‌های مداخله» (منطبق با پروپوزال و پروتکل مصوب)، و تغییر «طبقه‌بندی» مداخله در هر دو گروه از «other» به «رفتاری».
Intervention groups
#1
Other
Behavior
otherbehavior
Intervention group: Once the validity of the educational content has been confirmed, the intervention group will form a virtual group at telegram or whatsapp and the training program will be delivered to them through the virtual program within 6-12 weeks. In addition, the intervention group will receive routine care.
Intervention group: Once the validity of the educational content has been confirmed, the intervention group will form a virtual group at telegram or whatsapp and the training program will be delivered to them through the virtual program in 12 sessions within 6-12 weeks. In addition, the intervention group will receive routine care.
Intervention group: Once the validity of the educational content has been confirmed, the intervention group will form a virtual group at telegram or whatsapp and the training program will be delivered to them through the virtual program in 12 sessions within 6-12 weeks. In addition, the intervention group will receive routine care.
گروه مداخله: پس از تایید روایی محتوای آموزشی، برای گروه مداخله یک گروه مجازی در تلگرام یا واتس آپ تشکیل شده و برنامه ی آموزشی در طی 6-12 هفته از طریق برنامه مجازی به آنان ارائه خواهد شد. علاوه بر این گروه مداخله مراقبت های معمول بخش را نیز دریافت خواهند کرد.
گروه مداخله: پس از تایید روایی محتوای آموزشی، برای گروه مداخله یک گروه مجازی در تلگرام یا واتس‌آپ تشکیل شده و برنامه آموزشی ارتقاء خودکارآمدی در طی ۱۲ جلسه و طی مدت ۶ تا ۱۲ هفته از طریق برنامه مجازی به آنان ارائه خواهد شد. علاوه بر این، گروه مداخله مراقبت‌های معمول بخش را نیز دریافت خواهند کرد.
گروه مداخله: پس از تایید روایی محتوای آموزشی، برای گروه مداخله یک گروه مجازی در تلگرام یا واتس‌آپ تشکیل شده و برنامه ی آموزشی ارتقاء خودکارآمدی در طی 6-12۱۲ جلسه و طی مدت ۶ تا ۱۲ هفته از طریق برنامه مجازی به آنان ارائه خواهد شد. علاوه بر این، گروه مداخله مراقبت‌های معمول بخش را نیز دریافت خواهند کرد.
#2
Other
Behavior
otherbehavior
Recruitment centers
#1
Name of recruitment center - English: Labbafi Nejad Hospital
Name of recruitment center - Persian: بیمارستان لبافی نژاد
Full name of responsible person - English: armin azizikia
Full name of responsible person - Persian: آرمین عزیزی کیا
Street address - English: ferdos dormitory., sought ramin St., east ferdos Blvd., sadeghieh district., tehran city
Street address - Persian: تهران، صادقیه، بلوار فردوس شرق، خیابان رامین جنوبی، خوابگاه فردوس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1481999586
Phone: +98 44 3633 8120
Fax:
Email: arminazizikya@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Labbafi Nejad Hospital
Name of recruitment center - Persian: بیمارستان لبافی نژاد
Full name of responsible person - English: Armin Azizikia
Full name of responsible person - Persian: آرمین عزیزی کیا
Street address - English: Labbafinejad Hospital, 9th Boustan St., Pasdaran Ave., Tehran, Iran
Street address - Persian: تهران، پاسداران، خیابان شهید پایدارفرد، کنج خیابان بوستان نهم، بیمارستان شهید لبافی‌نژاد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1666663111
Phone: +98 21 23601
Fax:
Email: Arminazizikya@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Labbafi Nejad Hospital Name of recruitment center - Persian: بیمارستان لبافی نژاد Full name of responsible person - English: armin azizikiaArmin Azizikia Full name of responsible person - Persian: آرمین عزیزی کیا Street address - English: ferdos dormitory.Labbafinejad Hospital, sought ramin9th Boustan St., east ferdos BlvdPasdaran Ave., sadeghieh district.Tehran, tehran cityIran Street address - Persian: تهران، صادقیه، بلوار فردوس شرقپاسداران، خیابان رامین جنوبیشهید پایدارفرد، خوابگاه فردوسکنج خیابان بوستان نهم، بیمارستان شهید لبافی‌نژاد City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14819995861666663111 Phone: +98 44 3633 812021 23601 Fax: Email: arminazizikyaArminazizikya@sbmu.ac.ir Web page address:
#2
Name of recruitment center - English: Shohadaye Tajrish Hospital
Name of recruitment center - Persian: بیمارستان شهدای تجریش
Full name of responsible person - English: Armin Azizikia
Full name of responsible person - Persian: آرمین عزیزی کیا
Street address - English: Tajrish Sq., Shahrdari St., Shohadaye Tajrish Hospital
Street address - Persian: میدان تجریش، خیابان شهرداری، بیمارستان شهدای تجریش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1989934148
Phone: +98 21 2271 8001
Fax:
Email: Arminazizikya@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Shohadaye Tajrish Hospital Name of recruitment center - Persian: بیمارستان شهدای تجریش Full name of responsible person - English: Armin Azizikia Full name of responsible person - Persian: آرمین عزیزی کیا Street address - English: Tajrish Sq., Shahrdari St., Shohadaye Tajrish Hospital Street address - Persian: میدان تجریش، خیابان شهرداری، بیمارستان شهدای تجریش City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1989934148 Phone: +98 21 2271 8001 Fax: Email: Arminazizikya@sbmu.ac.ir Web page address:
#3
Name of recruitment center - English: Masih Daneshvari Hospital
Name of recruitment center - Persian: بیمارستان مسیح دانشوری
Full name of responsible person - English: Armin Azizikia
Full name of responsible person - Persian: آرمین عزیزی کیا
Street address - English: Niavaran, Darabad, Masih Daneshvari Hospital
Street address - Persian: نیاوران، دارآباد، بیمارستان مسیح دانشوری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1956944413
Phone: +98 21 2712 2000
Fax:
Email: Arminazizikya@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Masih Daneshvari Hospital Name of recruitment center - Persian: بیمارستان مسیح دانشوری Full name of responsible person - English: Armin Azizikia Full name of responsible person - Persian: آرمین عزیزی کیا Street address - English: Niavaran, Darabad, Masih Daneshvari Hospital Street address - Persian: نیاوران، دارآباد، بیمارستان مسیح دانشوری City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1956944413 Phone: +98 21 2712 2000 Fax: Email: Arminazizikya@sbmu.ac.ir Web page address:
#4
Name of recruitment center - English: Imam Hossein Hospital
Name of recruitment center - Persian: بیمارستان امام حسین (ع)
Full name of responsible person - English: Armin Azizikia
Full name of responsible person - Persian: آرمین عزیزی کیا
Street address - English: Imam Hossein Sq., Shahid Madani St., Imam Hossein Hospital
Street address - Persian: میدان امام حسین، خیابان شهید مدنی، بیمارستان امام حسین (ع)
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1617763141
Phone: +98 21 7343 3000
Fax:
Email: Arminazizikya@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Imam Hossein Hospital Name of recruitment center - Persian: بیمارستان امام حسین (ع) Full name of responsible person - English: Armin Azizikia Full name of responsible person - Persian: آرمین عزیزی کیا Street address - English: Imam Hossein Sq., Shahid Madani St., Imam Hossein Hospital Street address - Persian: میدان امام حسین، خیابان شهید مدنی، بیمارستان امام حسین (ع) City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1617763141 Phone: +98 21 7343 3000 Fax: Email: Arminazizikya@sbmu.ac.ir Web page address:
#5
Name of recruitment center - English: Shahid Modarres Hospital
Name of recruitment center - Persian: بیمارستان شهید مدرس
Full name of responsible person - English: Armin Azizikia
Full name of responsible person - Persian: آرمین عزیزی کیا
Street address - English: Saadat Abad, Yadegar-e-Imam Hwy., Shahid Modarres Hospital
Street address - Persian: سعادت‌آباد، تقاطع بزرگراه یادگار امام، بیمارستان شهید مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1998734383
Phone: +98 21 23515
Fax:
Email: Arminazizikya@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Shahid Modarres Hospital Name of recruitment center - Persian: بیمارستان شهید مدرس Full name of responsible person - English: Armin Azizikia Full name of responsible person - Persian: آرمین عزیزی کیا Street address - English: Saadat Abad, Yadegar-e-Imam Hwy., Shahid Modarres Hospital Street address - Persian: سعادت‌آباد، تقاطع بزرگراه یادگار امام، بیمارستان شهید مدرس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1998734383 Phone: +98 21 23515 Fax: Email: Arminazizikya@sbmu.ac.ir Web page address:
#6
Name of recruitment center - English: Taleghani Hospital
Name of recruitment center - Persian: بیمارستان آیت‌الله طالقانی
Full name of responsible person - English: Armin Azizikia
Full name of responsible person - Persian: آرمین عزیزی کیا
Street address - English: Velenjak, Tabnak St., Taleghani Hospital
Street address - Persian: ولنجک، خیابان تابناک (شهید اعرابی)، بیمارستان آیت‌الله طالقانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985711151
Phone: +98 21 2243 2560
Fax:
Email: Arminazizikya@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Taleghani Hospital Name of recruitment center - Persian: بیمارستان آیت‌الله طالقانی Full name of responsible person - English: Armin Azizikia Full name of responsible person - Persian: آرمین عزیزی کیا Street address - English: Velenjak, Tabnak St., Taleghani Hospital Street address - Persian: ولنجک، خیابان تابناک (شهید اعرابی)، بیمارستان آیت‌الله طالقانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985711151 Phone: +98 21 2243 2560 Fax: Email: Arminazizikya@sbmu.ac.ir Web page address:
#7
Name of recruitment center - English: Loghman Hospital
Name of recruitment center - Persian: بیمارستان لقمان حکیم
Full name of responsible person - English: Armin Azizikia
Full name of responsible person - Persian: آرمین عزیزی کیا
Street address - English: South Kargar St., Makhsous St., Loghman Hospital
Street address - Persian: خیابان کارگر جنوبی، خیابان مخصوص، بیمارستان لقمان حکیم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1333635445
Phone: +98 21 5541 9005
Fax:
Email: Arminazizikya@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Loghman Hospital Name of recruitment center - Persian: بیمارستان لقمان حکیم Full name of responsible person - English: Armin Azizikia Full name of responsible person - Persian: آرمین عزیزی کیا Street address - English: South Kargar St., Makhsous St., Loghman Hospital Street address - Persian: خیابان کارگر جنوبی، خیابان مخصوص، بیمارستان لقمان حکیم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1333635445 Phone: +98 21 5541 9005 Fax: Email: Arminazizikya@sbmu.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: معاونت پژوهشی دانشکده
Full name of responsible person - Persian: Vice chancellor for research, Faculty
Street address - English: Vali Asr Ave., Niayesh Cross Road, Niayesh Complex,
Street address - Persian: تهران - خیابان ولی عصر - تقاطع نیایش - مقابل بیمارستان قلب شهیدرجایی - دانشکده پرستاری ومامایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985717443
Phone: +98 21 8865 5366
Fax:
Email: mhdolatian@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Mahrokh Dolatian
Full name of responsible person - Persian: دکـتر مـاهـرخ دولـتیان
Street address - English: Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran
Street address - Persian: تهران - خیابان ولی عصر - تقاطع نیایش - مقابل بیمارستان قلب شهیدرجایی - دانشکده پرستاری ومامایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985717443
Phone: +98 21 8865 5366
Fax:
Email: mhdolatian@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: معاونت پژوهشی دانشکدهDr Mahrokh Dolatian Full name of responsible person - Persian: Vice chancellor for research, Facultyدکـتر مـاهـرخ دولـتیان Street address - English: Vali Asr Ave., Niayesh Cross Road, Niayesh Complex, Tehran, Iran Street address - Persian: تهران - خیابان ولی عصر - تقاطع نیایش - مقابل بیمارستان قلب شهیدرجایی - دانشکده پرستاری ومامایی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985717443 Phone: +98 21 8865 5366 Fax: Email: mhdolatian@gmail.com Web page address:
Protocol summary
Study aim
determining The Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients Referring to Dialysis Centers in Selected Hospitals of Shahid Beheshti University of Medical Sciences in 2019
Design
A prospective, randomized, open-label, routine care–controlled trial with a sample size of 35 in each group.
Settings and conduct
In this study, after determining the sample size, sampling will be done by available method and patients will be randomly assigned to two groups. In the experimental group, a self-efficacy program in addition to usual care is offered to hemodialysis patients, and in the control group only routine care is provided. The program will be run through 12 sessions, delivered over a period of 6 to 12 weeks, through the creation of a WhatsApp or Telegram group, which will include a self-efficacy training program.
Participants/Inclusion and exclusion criteria
inclusion criteria:
ages 18-65 years old
having the verbal communication ability
having the ability of self-care activities
having the history of dialysis at least for past one year
having dialysis 3-4 times per week
having the skill of using of Virtual messenger
exclusion criteria:
1.psychological disorders like psychosis and acute depression which needed to be hospitalized
2.Unwillingness to continuing participate in research
3.Any emergency event that may lead the patient to the intensive care unit.
Intervention groups
The intervention consisted of providing a self-efficacy training program that included aspects of participation in treatment, problem solving, self-care, and emotion control, and runs over 6–12 weeks. The intervention group will receive a self-efficacy training program in addition to routine nursing care in the ward. The control group will receive only routine care in the ward.
Main outcome variables
self managemet
General information
Reason for update
This update includes:
1. Completion of the previously empty "Actual recruitment start/end date" and "Trial completion date" fields, based on the actual study timeline.
2. Addition of contact information for six additional recruitment centers (beyond the originally registered center) that participated in the actual conduct of the study.
3. Correction of the study design description in the protocol summary from "double-blind/placebo-controlled" to "open-label/routine care-controlled," consistent with the actual methodology.
4. Correction of the number of intervention sessions from 6 to 12, consistent with the approved proposal and protocol.
5. Correction of the number of intervention sessions from 6 to 12 in the "Intervention Groups" section (consistent with the approved proposal and protocol), and reclassification of the intervention type for both groups from "other" to "behavioral."
Acronym
IRCT registration information
IRCT registration number:IRCT20191215045747N1
Registration date:2020-02-09, 1398/11/20
Registration timing:prospective
Last update:2026-10-02, 1405/07/10
Update count:1
Registration date
2020-02-09, 1398/11/20
Registrant information
Name
armin azizikia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3633 8120
Email address
arminazizikya@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2020-02-20, 1398/12/01
Actual recruitment end date
2020-04-19, 1399/01/31
Trial completion date
2020-07-21, 1399/04/31
Scientific title
The Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients
Public title
The Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
ages 18-65 years old
having the verbal communication ability
having the ability of self-care activities
having the history of dialysis at least for past one year
having dialysis 3-4 times per week
having the skill of using of Virtual messenger
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
61
Randomization (investigator's opinion)
Randomized
Randomization description
We drop a coin and one side is the control group and the other is the intervention group. We assign the first patient to the group based on the result and the next sample is assigned to the opposite group.
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 Shahid Beheshti University of Medical Sciences
Street address
Ferdos Dormitory., Sought Ramin St., East Ferdos Blvd., Sadeghieh District., Tehran Town
City
Tehran
Province
Tehran
Postal code
1481999586
Approval date
2019-12-02, 1398/09/11
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.244
Health conditions studied
1
Description of health condition studied
Chronic kidney Disease and Hemodialysis
ICD-10 code
Z99.2
ICD-10 code description
Applicable To Chronic kidney disease requiring chronic dialysisUse Additional code to identify dialysis status (Z99.2 )The following code(s) above N18.6 contain annotation back-referencesthat may be applicable to N18.6: N00-N99 Diseases of
Primary outcomes
1
Description
self-management score
Timepoint
determining Effect of Self-Efficacy Plan on Self-Management Behaviors in Hemodialysis Patients before and after intervention
Method of measurement
The hemodialysis self-management instrument (HDSMI) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Once the validity of the educational content has been confirmed, the intervention group will form a virtual group at telegram or whatsapp and the training program will be delivered to them through the virtual program in 12 sessions within 6-12 weeks. In addition, the intervention group will receive routine care.
Category
Behavior
2
Description
Control group: The control group is similar to the intervention group but will not receive any training or intervention except routine care.