Clinical trial comparing the effectiveness of empowerment program on the perception of risk and health dimensions in two groups of patients with coronary heart disease
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Protocol summary
This study is done to the investigate effect of empowerment program on perception of risk and health dimensions in patients with coronary heart disease. This study is clinical trial, randomized, available sample and permuted block randomization method, sample volume 84 person( each group 42 person). Patients with age of 18 to 65 years and ability of read and write can participate in study and they are omitted from the study upon appearance the acute phase of illness and patient death. By drawing lots between the two hospitals where the research is conducted, one place is allocated to test group and other to control group. On reaching the semi- study, for create equal conditions, groups study place is replaced. By obtaining a written consent indicating voluntary participation and prior to commencement of intervention, demographic and disease questionnaire and perception of risk and health dimensions questionnaire is completed by two groups. Intervention contains 3 workshop sessions in three consecutive days based on a 5-step MAGIC empowerment program is developed. Then, eight weekly telephone contacts in the 8 weeks to follow up are performed after the patient discharge of hospital. Control group receives routine cares of the ward. Then, at the end of intervention, the perception of risk and health dimensions questionnaire is completed by the patient in two groups. MAGIC empowerment program contains five steps: Motivating patient self-awareness, Assessing the causes of problems, Goal setting, Individual self-care plan development, and Checking whether the goal was reached.
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This study is done to the investigate effect of empowerment program on perception of risk and health dimensions in patients with coronary heart disease. This study is clinical trial, randomized, available sample and permuted block randomization method, sample volume 84 person( each group 42 person). Patients with age of 18 to 65 years and ability of read and write can participate in study and they are omitted from the study upon appearance the acute phase of illness and patient death. By drawing lots between the two hospitals where the research is conducted, one place is allocated to test group and other to control group. On reaching the semi- study, for create equal conditions, groups study place is replaced. By obtaining a written consent indicating voluntary participation and prior to commencement of intervention, demographic and disease questionnaire and perception of risk and health dimensions questionnaire is completed by two groups. Intervention contains 3 workshop sessions in three consecutive days based on a 5-step MAGIC empowerment program is developed. Then, eight weekly telephone contacts in the 8 weeks to follow up are performed after the patient discharge of hospital. Control group receives routine cares of the ward. Then, at the end of intervention, the perception of risk and health dimensions questionnaire is completed by the patient in two groups. MAGIC empowerment program contains five steps: Motivating patient self-awareness, Assessing the causes of problems, Goal setting, Individual self-care plan development, and Checking whether the goal was reached.
مطالعه با هدف بررسی تأثیر برنامه توانمندسازی بر درک از خطر و ابعاد سلامت در بیماران دارای بیماری عروق کرونر قلب انجام می شود. مطالعه کارآزمایی بالینی، تصادفی، روش نمونه گیری دردسترس و تصادف سازی بلوکی، حجم نمونه 84 نفر( هر گروه 42 نفر) است. بیماران با سن 18تا 65 سال و سواد خواندن و نوشتن می توانند در مطالعه شرکت و با بروز فاز حاد بیماری و فوت بیمار از مطالعه حذف می شوند. با قرعه کشی بین دو بیمارستان محل پژوهش، یکی به گروه آزمون و دیگری به کنترل اختصاص می یابد. با رسیدن به نیمه مطالعه، برای ایجاد شرایط مساوی، محل مطالعه گروه ها تعویض می شود. با اخذ رضایت کتبی برای شرکت داوطلبانه و قبل از شروع مداخله، پرسشنامه دموگرافیک و بیماری و پرسشنامه درک از خطر و ابعاد سلامت توسط دو گروه تکمیل می شود. مداخله شامل 3 جلسه کارگاه مبتنی بر برنامه توانمندسازی 5 مرحله ای مژیک صورت می گیرد، سپس هشت تماس تلفنی هفتگی به مدت 8 هفته برای پیگیری بعد از ترخیص بیماراز بیمارستان انجام می شود. گروه کنترل مراقبت های معمول بخش را دریافت می نماید. سپس، در پایان مداخله، پرسشنامه درک از خطر و ابعاد سلامت توسط بیماردر دو گروه تکمیل می شود. برنامه توانمندسازی مژیک شامل پنج مرحله: تحریک خودآگاهی بیمار، بررسی علل مشکلات، تنظیم هدف، توسعه طرح خودمراقبتی فردی و ارزشیابی دستیابی به هدف است.
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مطالعه با هدف بررسی تأثیر برنامه توانمندسازی بر درک از خطر و ابعاد سلامت در بیماران دارای بیماری عروق کرونر قلب انجام می شود. مطالعه کارآزمایی بالینی، تصادفی، روش نمونه گیری دردسترس و تصادف سازی بلوکی، حجم نمونه 84 نفر( هر گروه 42 نفر) است. بیماران با سن 18تا 65 سال و سواد خواندن و نوشتن می توانند در مطالعه شرکت و با بروز فاز حاد بیماری و فوت بیمار از مطالعه حذف می شوند. با قرعه کشی بین دو بیمارستان محل پژوهش، یکی به گروه آزمون و دیگری به کنترل اختصاص می یابد. با رسیدن به نیمه مطالعه، برای ایجاد شرایط مساوی، محل مطالعه گروه ها تعویض می شود. با اخذ رضایت کتبی برای شرکت داوطلبانه و قبل از شروع مداخله، پرسشنامه دموگرافیک و بیماری و پرسشنامه درک از خطر و ابعاد سلامت توسط دو گروه تکمیل می شود. مداخله شامل 3 جلسه کارگاه مبتنی بر برنامه توانمندسازی 5 مرحله ای مژیک صورت می گیرد، سپس هشت تماس تلفنی هفتگی به مدت 8 هفته برای پیگیری بعد از ترخیص بیماراز بیمارستان انجام می شود. گروه کنترل مراقبت های معمول بخش را دریافت می نماید. سپس، در پایان مداخله، پرسشنامه درک از خطر و ابعاد سلامت توسط بیماردر دو گروه تکمیل می شود. برنامه توانمندسازی مژیک شامل پنج مرحله: تحریک خودآگاهی بیمار، بررسی علل مشکلات، تنظیم هدف، توسعه طرح خودمراقبتی فردی و ارزشیابی دستیابی به هدف است.
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the investigate effect of empowerment program on perception of risk and health dimensions in patients with coronary heart disease
the investigate effect of empowerment program on perception of risk and health dimensions in patients with coronary heart disease
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بررسی تأثیر برنامه توانمندسازی بر درک از خطر و ابعاد سلامت در بیماران دارای بیماری عروق کرونر قلب
بررسی تأثیر برنامه توانمندسازی بر درک از خطر و ابعاد سلامت در بیماران دارای بیماری عروق کرونر قلب
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clinical trial, randomized, available sample and Block Balanced Randomization (BBR) method
clinical trial, randomized, available sample and Block Balanced Randomization (BBR) method
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کارآزمایی بالینی، تصادفی، روش نمونه گیری دردسترس و تخصیص تصادفی بلوکی
کارآزمایی بالینی، تصادفی، روش نمونه گیری دردسترس و تخصیص تصادفی بلوکی
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The present study is carried out in the Post CCU offices of Tehran Heart Center. Assignment of patients in two groups of test and control was done by Block Balanced Randomization method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com. By obtaining a written consent indicating voluntary participation and prior to commencement of intervention, demographic and disease questionnaire and perception of risk and health dimensions questionnaire is completed by two groups. Intervention contains 3 workshop sessions in three consecutive days based on a 5-step MAGIC empowerment program is developed. Then, eight weekly telephone contacts in the 8 weeks to follow up are performed after the patient discharge of hospital. Control group receives routine cares of the ward. Then, at the end of intervention, the perception of risk and health dimensions questionnaire is completed by the patient in two groups. MAGIC empowerment program contains five steps: Motivating patient self-awareness, Assessing the causes of problems, Goal setting, Individual self-care plan development, and Checking whether the goal was reached.
The present study is carried out in the Post CCU offices of Tehran Heart Center. Assignment of patients in two groups of test and control was done by Block Balanced Randomization method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com. By obtaining a written consent indicating voluntary participation and prior to commencement of intervention, demographic and disease questionnaire and perception of risk and health dimensions questionnaire is completed by two groups. Intervention contains 3 workshop sessions in three consecutive days based on a 5-step MAGIC empowerment program is developed. Then, eight weekly telephone contacts in the 8 weeks to follow up are performed after the patient discharge of hospital. Control group receives routine cares of the ward. Then, at the end of intervention, the perception of risk and health dimensions questionnaire is completed by the patient in two groups. MAGIC empowerment program contains five steps: Motivating patient self-awareness, Assessing the causes of problems, Goal setting, Individual self-care plan development, and Checking whether the goal was reached.
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پژوهش حاضر در بخش های Post CCU مرکز قلب تهران انجام می شود. تخصيص بيماران در دو گروه آزمون و کنترل به روش تخصيص تصادفی بلوکی انجام می شود. توالی تخصیص با استفاده از سامانه ی تحت وب رایگان به آدرس http://www.randomization.com تولید می شود.با اخذ رضایت کتبی برای شرکت داوطلبانه و قبل از شروع مداخله، پرسشنامه دموگرافیک و بیماری و پرسشنامه درک از خطر و ابعاد سلامت توسط دو گروه تکمیل می شود. مداخله شامل 3 جلسه کارگاه مبتنی بر برنامه توانمندسازی 5 مرحله ای مژیک صورت می گیرد، سپس هشت تماس تلفنی هفتگی به مدت 8 هفته برای پیگیری بعد از ترخیص بیماراز بیمارستان انجام می شود. گروه کنترل مراقبت های معمول بخش را دریافت می نماید. سپس، در پایان مداخله، پرسشنامه درک از خطر و ابعاد سلامت توسط بیماردر دو گروه تکمیل می شود. برنامه توانمندسازی مژیک شامل پنج مرحله: تحریک خودآگاهی بیمار، بررسی علل مشکلات، تنظیم هدف، توسعه طرح خودمراقبتی فردی و ارزشیابی دستیابی به هدف است.
پژوهش حاضر در بخش های Post CCU مرکز قلب تهران انجام می شود. تخصيص بيماران در دو گروه آزمون و کنترل به روش تخصيص تصادفی بلوکی انجام می شود. توالی تخصیص با استفاده از سامانه ی تحت وب رایگان به آدرس http://www.randomization.com تولید می شود.با اخذ رضایت کتبی برای شرکت داوطلبانه و قبل از شروع مداخله، پرسشنامه دموگرافیک و بیماری و پرسشنامه درک از خطر و ابعاد سلامت توسط دو گروه تکمیل می شود. مداخله شامل 3 جلسه کارگاه مبتنی بر برنامه توانمندسازی 5 مرحله ای مژیک صورت می گیرد، سپس هشت تماس تلفنی هفتگی به مدت 8 هفته برای پیگیری بعد از ترخیص بیماراز بیمارستان انجام می شود. گروه کنترل مراقبت های معمول بخش را دریافت می نماید. سپس، در پایان مداخله، پرسشنامه درک از خطر و ابعاد سلامت توسط بیماردر دو گروه تکمیل می شود. برنامه توانمندسازی مژیک شامل پنج مرحله: تحریک خودآگاهی بیمار، بررسی علل مشکلات، تنظیم هدف، توسعه طرح خودمراقبتی فردی و ارزشیابی دستیابی به هدف است.
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Patients with age of 18 to 65 years and ability of read and write can participate in study and they are omitted from the study upon appearance the acute phase of illness and patient death.
Patients with age of 18 to 65 years and ability of read and write can participate in study and they are omitted from the study upon appearance the acute phase of illness and patient death.
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بیماران با سن 18تا 65 سال و سواد خواندن و نوشتن می توانند در مطالعه شرکت و با بروز فاز حاد بیماری و فوت بیمار از مطالعه حذف می شوند.
بیماران با سن 18تا 65 سال و سواد خواندن و نوشتن می توانند در مطالعه شرکت و با بروز فاز حاد بیماری و فوت بیمار از مطالعه حذف می شوند.
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patients with coronary heart disease
patients with coronary heart disease
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بیماران دارای بیماری عروق کرونر قلب
بیماران دارای بیماری عروق کرونر قلب
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empowerment program
empowerment program
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برنامه توانمندسازی
برنامه توانمندسازی
General information
adult 18-65 years; least ability to read and write; diagnosis of ischemic heart disease through diagnostic tests and physician; Ability to communicate; being in stable condition.
adult 18-65 years; least ability to read and write; diagnosis of ischemic heart disease through diagnostic tests and physician; Ability to communicate; being in stable condition.
بزرگسالان بین 65-18 سال؛ داشتن حداقل سواد خواندن و نوشتن؛ تشخیص بیماری ایسکمیک قلبی از طریق تست های تشخیصی و تایید پزشک؛ توانایی برقراری ارتباط؛ قرار داشتن در وضعیت پایدار بیماری.
بزرگسالان بین 65-18 سال؛ داشتن حداقل سواد خواندن و نوشتن؛ تشخیص بیماری ایسکمیک قلبی از طریق تست های تشخیصی و تایید پزشک؛ توانایی برقراری ارتباط؛ قرار داشتن در وضعیت پایدار بیماری.
psychological problems; participate in the empowerment of similar.
psychological problems; participate in the empowerment of similar.
وجود مشکلات روانشناختی تشخیص داده شده؛ شرکت در برنامه ی توانمندسازی مشابه.
وجود مشکلات روانشناختی تشخیص داده شده؛ شرکت در برنامه ی توانمندسازی مشابه.
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Assignment of patients in two groups of test and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com.
Assignment of patients in two groups of test and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com.
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تخصيص بيماران در دو گروه مداخله و کنترل به روش تخصيص تصادفی بلوکی انجام می شود. توالی تخصیص با استفاده از سامانه ی تحت وب رایگان به آدرس http://www.randomization.com تولید می شود.
تخصيص بيماران در دو گروه مداخله و کنترل به روش تخصيص تصادفی بلوکی انجام می شود. توالی تخصیص با استفاده از سامانه ی تحت وب رایگان به آدرس http://www.randomization.com تولید می شود.
Recruitment centers
#1
Name of recruitment center - English: Imam Khomeini hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Zakerimoqhadam masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Street address - English:
Street address - Persian:
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: Tehran Heart Center hospital
Name of recruitment center - Persian: بیمارستان مرکز قلب تهران
Full name of responsible person - English: Zakerimoqhadam masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Street address - English: North Kargar Street, Tehran Province, Tehran, Iran
Street address - Persian: خیابان کارگر شمالی، استان تهران، تهران، ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713138
Phone: +98 21 8802 9600
Fax:
Email: mzakerimo@gmail.com
Web page address:
Name of recruitment center - English: Imam KhomeiniTehran Heart Center hospital Name of recruitment center - Persian: بیمارستان امام خمینیمرکز قلب تهران Full name of responsible person - English: Zakerimoqhadam masoumeh Full name of responsible person - Persian: معصومه ذاکری مقدم Street address - English: North Kargar Street, Tehran Province, Tehran, Iran Street address - Persian: خیابان کارگر شمالی، استان تهران، تهران، ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713138 Phone: +98 21 8802 9600 Fax: Email: mzakerimo@gmail.com Web page address:
#2
Name of recruitment center - English: shariati hospital
Name of recruitment center - Persian: بیمارستان شریعتی
Full name of responsible person - English: Zakerimoqhadam masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Street address - English:
Street address - Persian:
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: shariati hospital Name of recruitment center - Persian: بیمارستان شریعتی Full name of responsible person - English: Zakerimoqhadam masoumeh Full name of responsible person - Persian: معصومه ذاکری مقدم Street address - English: Street address - Persian: City - English: Tehran City - Persian: تهران Province: Country: Iran (Islamic Republic of) Postal code: Phone: Fax: Email: Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research of Tehran university of medical sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Zakerimoghadam Masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Street address - English: Eastern Nosrat street, Tohid square
Street address - Persian: میدان توحید، خیابان نصرت شرقی
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 Tehran university of medical sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Zakerimoghadam Masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Street address - English: Eastern Nosrat street, Tohid square
Street address - Persian: میدان توحید، خیابان نصرت شرقی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8163 3698
Fax:
Email: mzakerimo@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research of Tehran university of medical sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی تهران Full name of responsible person - English: Zakerimoghadam Masoumeh Full name of responsible person - Persian: معصومه ذاکری مقدم Street address - English: Eastern Nosrat street, Tohid square Street address - Persian: میدان توحید، خیابان نصرت شرقی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 8163 3698 Fax: Email: mzakerimo@gmail.com Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Nursing midwifery faculty of Tehran university of medical sciences
Name of organization / entity - Persian: دانشکده پرستاری مامایی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Zakerimoghadam Masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Position - English: Nursing education PHD, Faculty member
Position - Persian: عضو هیئت علمی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Eastern Nosrat street, Tohid square
Street address - Persian: میدان توحید؛ خیابان نصرت شرقی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 6692 7171
Mobile: +98 912 540 4964
Fax:
Email: zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Nursing midwifery faculty of Tehran university of medical sciences
Name of organization / entity - Persian: دانشکده پرستاری مامایی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Zakerimoghadam Masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Position - English: Nursing education PHD, Faculty member
Position - Persian: عضو هیئت علمی
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Eastern Nosrat street, Tohid square
Street address - Persian: میدان توحید؛ خیابان نصرت شرقی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1419733171
Phone: +98 21 6692 7171
Mobile: +98 912 540 4964
Fax:
Email: zakerimo@sina.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Nursing midwifery faculty of Tehran university of medical sciences Name of organization / entity - Persian: دانشکده پرستاری مامایی دانشگاه علوم پزشکی تهران Full name of responsible person - English: Zakerimoghadam Masoumeh Full name of responsible person - Persian: معصومه ذاکری مقدم Position - English: Nursing education PHD, Faculty member Position - Persian: عضو هیئت علمی Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Eastern Nosrat street, Tohid square Street address - Persian: میدان توحید؛ خیابان نصرت شرقی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1419733171 Phone: +98 21 6692 7171 Mobile: +98 912 540 4964 Fax: Email: zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Nursing midwifery faculty of Tehran university of medical Sciences
Name of organization / entity - Persian: دانشکده پرستاری مامایی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Zakerimoghadam Masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Position - English: Nursing education PHD، Faculty member
Position - Persian: دکترای آموزش پرستاری؛ عضو هیئت علمی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Eastern Nosrat street, Tohid square
Street address - Persian: میدان توحید؛ خیابان نصرت شرقی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 6692 7171
Mobile: +98 912 540 4964
Fax:
Email: zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Nursing midwifery faculty of Tehran university of medical Sciences
Name of organization / entity - Persian: دانشکده پرستاری مامایی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Zakerimoghadam Masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Position - English: Nursing education PHD، Faculty member
Position - Persian: دکترای آموزش پرستاری؛ عضو هیئت علمی
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Eastern Nosrat street, Tohid square
Street address - Persian: میدان توحید؛ خیابان نصرت شرقی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1419733171
Phone: +98 21 6692 7171
Mobile: +98 912 540 4964
Fax:
Email: zakerimo@sina.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Nursing midwifery faculty of Tehran university of medical Sciences Name of organization / entity - Persian: دانشکده پرستاری مامایی دانشگاه علوم پزشکی تهران Full name of responsible person - English: Zakerimoghadam Masoumeh Full name of responsible person - Persian: معصومه ذاکری مقدم Position - English: Nursing education PHD، Faculty member Position - Persian: دکترای آموزش پرستاری؛ عضو هیئت علمی Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Eastern Nosrat street, Tohid square Street address - Persian: میدان توحید؛ خیابان نصرت شرقی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1419733171 Phone: +98 21 6692 7171 Mobile: +98 912 540 4964 Fax: Email: zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Nursing midwifery faculty of Tehran university of medical Sciences
Name of organization / entity - Persian: دانشکده پرستاری مامایی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Zakeromoghadam Masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Position - English: Nursing education PHD, Faculty member
Position - Persian: دکترای آموزش پرستاری؛ عضو هیئت علمی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Eastern Nosrat street, Tohid square
Street address - Persian: میدان توحید؛ خیابان نصرت شرقی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 6692 7171
Mobile: +98 915 404 964
Fax:
Email: zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Nursing midwifery faculty of Tehran university of medical Sciences
Name of organization / entity - Persian: دانشکده پرستاری مامایی دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Zakeromoghadam Masoumeh
Full name of responsible person - Persian: معصومه ذاکری مقدم
Position - English: Nursing education PHD, Faculty member
Position - Persian: دکترای آموزش پرستاری؛ عضو هیئت علمی
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Eastern Nosrat street, Tohid square
Street address - Persian: میدان توحید؛ خیابان نصرت شرقی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1419733171
Phone: +98 21 6692 7171
Mobile: +98 915 404 964
Fax:
Email: zakerimo@sina.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Nursing midwifery faculty of Tehran university of medical Sciences Name of organization / entity - Persian: دانشکده پرستاری مامایی دانشگاه علوم پزشکی تهران Full name of responsible person - English: Zakeromoghadam Masoumeh Full name of responsible person - Persian: معصومه ذاکری مقدم Position - English: Nursing education PHD, Faculty member Position - Persian: دکترای آموزش پرستاری؛ عضو هیئت علمی Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Eastern Nosrat street, Tohid square Street address - Persian: میدان توحید؛ خیابان نصرت شرقی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1419733171 Phone: +98 21 6692 7171 Mobile: +98 915 404 964 Fax: Email: zakerimo@gmail.com؛ zakerimo@sina.tums.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
I do not think
I do not think
empty
فکر نکرده ام
فکر نکرده ام
Protocol summary
Study aim
the investigate effect of empowerment program on perception of risk and health dimensions in patients with coronary heart disease
Design
clinical trial, randomized, available sample and Block Balanced Randomization (BBR) method
Settings and conduct
The present study is carried out in the Post CCU offices of Tehran Heart Center. Assignment of patients in two groups of test and control was done by Block Balanced Randomization method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com. By obtaining a written consent indicating voluntary participation and prior to commencement of intervention, demographic and disease questionnaire and perception of risk and health dimensions questionnaire is completed by two groups. Intervention contains 3 workshop sessions in three consecutive days based on a 5-step MAGIC empowerment program is developed. Then, eight weekly telephone contacts in the 8 weeks to follow up are performed after the patient discharge of hospital. Control group receives routine cares of the ward. Then, at the end of intervention, the perception of risk and health dimensions questionnaire is completed by the patient in two groups. MAGIC empowerment program contains five steps: Motivating patient self-awareness, Assessing the causes of problems, Goal setting, Individual self-care plan development, and Checking whether the goal was reached.
Participants/Inclusion and exclusion criteria
Patients with age of 18 to 65 years and ability of read and write can participate in study and they are omitted from the study upon appearance the acute phase of illness and patient death.
Intervention groups
patients with coronary heart disease
Main outcome variables
empowerment program
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201607254443N22
Registration date:2017-06-30, 1396/04/09
Registration timing:prospective
Last update:2018-01-01, 1396/10/11
Update count:1
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputyof Tehran University of Medical Sciense
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effectiveness of empowerment program on the perception of risk and health dimensions in two groups of patients with coronary heart disease
Public title
ٍEffect of empowerment program on the perception of risk and health dimensions in patients with coronary heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
adult 18-65 years; least ability to read and write; diagnosis of ischemic heart disease through diagnostic tests and physician; Ability to communicate; being in stable condition.
Exclusion criteria:
psychological problems; participate in the empowerment of similar.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients in two groups of test and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com.
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
Tehran University of Medical Sciences
Street address
Ghods street, Keshvarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2691
Health conditions studied
1
Description of health condition studied
coronary artery disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
perception of risk
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
the perception of risk of heart disease scale(PRHDS)
2
Description
physical health
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
Seattle Angina Questionnaire(SAQ)
3
Description
life satisfaction
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
Life Engagement Test(LET)
4
Description
life orientation
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
Revised Life Orientation Test(LOT-R)
5
Description
optimism
Timepoint
Before the the intervention, immediately after ending the intervention
Method of measurement
Revised Life Orientation Test(LOT-R)
Secondary outcomes
empty
Intervention groups
1
Description
In control group no intervention is conducted by researcher and patients receive routine cares of the ward.
Category
Other
2
Description
In test group, intervention contains 3 workshop sessions in three consecutive days based on a 5-step MAGIC empowerment program is developed. Then, eight weekly telephone contacts in the 8 weeks to follow up are performed after the patient discharge of hospital.
MAGIC empowerment program contains five steps: Motivating patient self-awareness, Assessing the causes of problems, Goal setting, Individual self-care plan development, and Checking whether the goal was reached.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center hospital
Full name of responsible person
Zakerimoqhadam masoumeh
Street address
North Kargar Street, Tehran Province, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
mzakerimo@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Tehran university of medical sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
mzakerimo@gmail.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 of Tehran 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
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Position
Nursing education PHD, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical Sciences
Full name of responsible person
Zakerimoghadam Masoumeh
Position
Nursing education PHD، Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing midwifery faculty of Tehran university of medical Sciences
Full name of responsible person
Zakeromoghadam Masoumeh
Position
Nursing education PHD, Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Eastern Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
zakerimo@sina.tums.ac.ir
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
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