History
# Registration date Revision Id
2 2022-05-19, 1401/02/29 235796
1 2017-08-16, 1396/05/25 26425
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  • Protocol summary

    The purpose of this study is to investigate of effect of family-centered empowerment model based lifestyle modification on quality of life of patients with Pemphigus Vulgaris and active family members. This is a clinical trial study. Inclusion criteria are register Pemphigus Vulgaris according to the doctor's diagnosis in the health case; women aged 30-60 years; having at least literacy to complete the Questionnaire; type of disease (skin, mucous and skin - mucous); severity of illness (off, mild, moderate, severe); duration of illness (less than three months, between three months to one year, between one year and three years, more than three years). Exclusion criteria are the patient and active family member's unwillingness to continue to participate in research; the patient has an acute or chronic illness; the patient has a mental illness; Patient or active family member death. The intervention for the intervention group in order to empowering patients is through theoretical and practical training and for the control group, intervention is not performed. After executing the model the end-of-power level will be compared with the initial ability level. According to the analysis of life style Questionnaire, Sf-36 quality of life Questionnaire and empowerment measurement Questionnaire; theoretical and practical training is given and its impact on patients' quality of life is measured. The sample size is 144 people which are divided into two groups of 72 people
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    هدف از این مطالعه بررسی تاثیر اجرای الگوی توانمندسازی خانواده محور مبتنی بر اصلاح سبک زندگی برکیفیت زندگی بیماران زن مبتلا به پمفیگوس ولگاریس و عضو فعال خانواده ها می باشد. این مطالعه از نوع کارآزمایی بالینی است. شرایط ورود به مطالعه عبارتند از ثبت پمفیگوس ولگاریس طبق تشخیص پزشک در پرونده بهداشتی فرد؛ زنان در محدوده سنی 30 تا 60 سال؛ داشتن حداقل سواد جهت تکمیل پرسشنامه؛ نوع بیماری (پوستی، مخاطی و پوستی – مخاطی)؛ شدت بیماری (خاموش، خفیف، متوسط و شدید)؛ مدت ابتلا به بیماری (کمتر از سه ماه، بین سه ماه تا یکسال، بین یکسال تا سه سال و بیشتر از سه سال) و شرایط خروج از مطالعه شامل عدم تمایل بیمار یا عضو فعال خانواده به ادامه شرکت در برنامه توانمندسازی؛ ابتلا بیمار به بیماری حاد یا مزمن دیگر؛ ابتلا بیمار به بیماری اعصاب و روان؛ فوت بیمار یا عضو فعال خانواده می باشد. مداخله برای گروه مداخله به صورت توانمندسازی بیماران از طریق آموزش تئوری و عملی انجام می شود و برای گروه کنترل مداخله انجام نمی شود. بعد از مداخله میزان توانمندی پایان مطالعه با میزان توانمندی اولیه مقایسه خواهد شد. به گروه مداخله بر اساس تحلیل پرسشنامه های سبک زندگی، کیفیت زندگی و سنجش توانمندی آموزش ها داده می شود و تاثیر آن بر روی کیفیت زندگی بیماران سنجیده می شود. تعداد حجم نمونه 144 نفر می باشد که در دو گروه 72 نفری تقسیم شده اند.
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    Health services
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    تحقیقات در سیستم ارائه خدمات سلامت.
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    matched controlled clinical trial study; parallel group; No blinding; Simple randomization using lottery.
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    کارآزمایی بالینی شاهددار همسان شده دارای گروه کنترل، با گروه های موازی ، بدون کورسازی ، تصادفی سازی ساده با استفاده از قرعه کشی.
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    This matched controlled clinical trial study was conducted by Purposive sampling 72 female patients with Pemphigus Vulgaris and 72 active family members and through random allocation was divided into two groups: intervention and control. Data were collected by demographic, specialty instrument of empowerment of patients and specialty instrument of active family members questionnaires, Lifestyle (HPLP II) and SF-36 for patients and active family members , dermatology life quality index, the family Dermatology life quality index (FDLQI) questionnaires. FCEM implemented in steps (perceived threat, self-efficacy, self-esteem and evaluations) for the intervention group. Usual care was done for control group. After 6 weeks, was compared with the control. Data was analyzed by statistical software SPSS V.24, and rate (P <0.05) was considered significant.
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    طالعه کارآزمایی بالینی شاهددار همسان شده با انتخاب 72 بیمار زن پمفیگوس ولگاریس و 72 عضو فعال خانواده از طریق نمونه گیری مبتنی بر هدف و تخصیص تصادفی آنها به دو گروه مداخله و کنترل در سال 1396 در بیمارستان پوست رازی انجام شد. داده ها از طریق پرسشنامه های جمعیت شناختی، سنجش توانمندی بیماران، سنجش توانمندی عضو فعال خانواده ها، سبک زندگی واکر(HPLP II) برای بیماران و عضو فعال خانواده ها، کیفیت زندگی اختصاصی بیماران پوستی، کیفیت زندگی اختصاصی خانواده بیماران پوستی جمع آوری شد. الگوی توانمندسازی در گام های(درک تهدید، خودکارآمدی، خودباوری و ارزشیابی) برای گروه مداخله و مراقبت رایج برای گروه کنترل اجرا شد و پس از 6 هفته پایش با گروه کنترل مقایسه شد. داده ها با نرم افزارSPSS V.24 و آزمون های آماری با (p<0/05 ) تجزیه و تحلیل شد.
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    Inclusion criteria: register Pemphigus Vulgaris in the health case; Patients' and active family member's satisfaction ; Ability to communicate; No mental illness or other acute or chronic illness; Not a member of health team and having at least literacy. Exclusion criteria: the patient and active family member's unwillingness to continue; patient has an acute or chronic illness; the patient has a mental illness; Patient or active family member death.
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    شرایط ورود: ثبت پمفیگوس ولگاریس در پرونده بهداشتی فرد، رضایت بیماران و عضو فعال خانواده ، توان برقراری ارتباط ، مبتلا نبودن به بیماری روان یا بیماری حاد یا مزمن دیگر، عضو تیم بهداشتی نبودن و داشتن حداقل سواد. شرایط عدم ورود: عدم تمایل بیمار یا عضو فعال خانواده به ادامه؛ ابتلا بیمار به بیماری حاد یا مزمن دیگر؛ ابتلا بیمار به بیماری اعصاب و روان؛ فوت بیمار یا عضو فعال خانواده.
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    female patients with Pemphigus Vulgaris and active family member in two groups of intervention and control.
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    بیماران زن مبتلا به پمفیگوس ولگاریس و عضو فعال خانواده در دو گروه مداخله و کنترل.
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    Quality of public and Exclusive life of female patients with Pemphigus Vulgaris and active family member.
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    کیفیت زندگی عمومی و اختصاصی زنان مبتلا به پمفیگوس ولگاریس و عضو فعال خانواده.
  • General information

    N/A
    Randomized
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    144
    2017-07-23, 1396/05/01
    2017-08-23, 1396/06/01
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    2017-06-22, 1396/04/01
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    2017-07-23, 1396/05/01
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    2017-09-23, 1396/07/01
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    Add primary and secondary outcome variable
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    اضافه کردن متغیر پیامد اولیه و متغیر پیامد ثانویه
    register Pemphigus Vulgaris according to the doctor's diagnosis in the health case
    women aged 30-60 years
    Patients' and active family member's desire and satisfaction to participate in the research;
    Ability to communicate verbally ; provide information and collaborate with the researcher
    No mental illness or other acute or chronic illness
    Not a member of the health team
    having at least literacy to complete the Questionnaire
    ثبت پمفیگوس ولگاریس طبق تشخیص پزشک در پرونده بهداشتی فرد
    محدوده سنی 30 تا 60 سال
    تمایل و رضایت بیماران و عضو فعال خانواده برای شرکت در پژوهش
    توان برقراری ارتباط کلامی، ارائه اطلاعات و همکاری با پژوهشگر
    مبتلا نبودن به بیماری روان یا بیماری حاد یا مزمن دیگر
    عضو تیم بهداشتی نبودن
    داشتن حداقل سواد جهت تکمیل پرسشنامه
    the patient and active family member's unwillingness to continue to participate in research
    the patient has an acute or chronic illness
    the patient has a mental illness
    Patient or active family member death
    عدم تمایل بیمار یا عضو فعال خانواده به ادامه شرکت در برنامه توانمندسازی
    ابتلا بیمار به بیماری حاد یا مزمن دیگر
    ابتلا بیمار به بیماری اعصاب و روان
    فوت بیمار یا عضو فعال خانواده
    Health services research
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    In this study, the research samples were selected by the researcher using the purposeful sampling method by studying the patients' files to reach the qualified patients more precisely, according to the entry criteria and after assimilation by one of the nurses based on the criteria of age, type of disease, severity of the disease and duration of the disease, the block was randomly assigned and then, using the Minimization method, the samples were homogenized by SPSS software and by using lottery and randomly, the research samples were placed in one of the control or intervention groups.
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    در این مطالعه، نمونه های پژوهش توسط پژوهشگر به روش نمونه گیری هدفمند با مطالعه پرونده بیماران برای دستیابی دقیق تر به بیماران واجد شرایط، با توجه به معیارهای ورود انتخاب شدند و پس از همسان سازي توسط یکی از پرستاران همکار بر اساس معیارهای سن، نوع بیماری، شدت بیماری و مدت ابتلا به بیماری به روش تخصیص تصادفی، بلوک شده و سپس با استفاده از روش (Minimization) به وسیله نرم افزار SPSS همگونه سازي نمونه ها انجام شد و با استفاده از قرعه كشي و به شكل تصادفي نمونه های پژوهش در يكي از گروه هاي كنترل يا مداخله قرار گرفتند.
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  • Health conditions studied

    #1
    L10, L11,
    L10.0
  • Secondary outcomes

    #1
    Quality of life of female patients with Pemphigus Vulgaris and active family member
    Quality of public life of female patients with Pemphigus Vulgaris and active family member
    کیفیت زندگی زنان مبتلا به پمفیگوس ولگاریس و عضو فعال خانواده
    کیفیت زندگی عمومی زنان مبتلا به پمفیگوس ولگاریس و عضو فعال خانواده
    #2
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    Quality of Exclusive life of female patients with Pemphigus Vulgaris
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    کیفیت زندگی اختصاصی زنان مبتلا به پمفیگوس ولگاریس
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    Before intervention; two months after the end of the intervention
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    قبل از مداخله – دو ماه پس ازاتمام مداخله
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    Iranian version dermatology life quality index (DLQI)
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    نسخه ایرانی پرسشنامه کیفیت زندگی اختصاصی بیماران مبتلا به بیماری پوست (DLQI)
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    Quality of exclusive life of active family member.
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    کیفیت زندگی اختصاصی عضو فعال خانواده.
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    Before intervention; two months after the end of the intervention.
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    قبل از مداخله – دو ماه پس ازاتمام مداخله.
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    The family dermatology life quality index (FDLQI).
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    پرسشنامه کیفیت زندگی اختصاصی خانواده بیماران پوستی ( (FDLQI).
  • Intervention groups

    #1
    intervention group: implementation of family-centered empowerment model in four executive steps - For eight sessions for eight sessions
    After analyzing the data before the intervention, which led to the identification of the resources, limitations, needs and strengths of the patient and his active family member in different fields, Changes were made in the previously designed empowerment program for these patients, so that the implementation of the empowerment model fits the needs and demands of the research samples. After the pre-test, the intervention phase began and since this study was conducted as an intervention and control; The intervention phase was performed only for the intervention group and the control group did not receive any intervention. In the intervention group, the family-centered empowerment model in executive steps (understanding the threat, internalizing the axis of control, self-efficacy, self-belief, self-control, follow-up and evaluation) for 8 sessions by group problem solving method and using educational participation method and adult educational theory for The intervention group was implemented and after 6 weeks, were compared with the control group.
    برای گروه مداخله (اجرای الگوی توانمندسازی خانواده محور در چهار گام الگو – به مدت هشت جلسه)
    پس از تجزیه و تحلیل داده ها قبل از مداخله که منجر به شناسایی منابع ، محدودیت ها ، نیازها و نقاط قوت ضعف بیمار و عضو فعال خانواده او در زمینه مختلف شد، تغییراتی در برنامه ی توانمند سازی از قبل طراحی شده برای این بیماران، داده شد تا اجرای الگوی توانمند سازی متناسب با نیازها و خواسته های نمونه های پژوهش باشد. پس از انجام پیش آزمون مرحله مداخله آغاز شد و از آنجا که این مطالعه به صورت مداخله و کنترل انجام شد؛ مرحله مداخله فقط برای گروه مداخله انجام شد و گروه کنترل هیچگونه مداخله ای دریافت نکرد. درگروه مداخله، الگوی توانمندسازی خانواده محور در گام های اجرایی (درک تهدید، درونی کردن محورکنترل، خودکارآمدی، خودباوری، خودکنترلی، پیگیری و ارزشیابی) به مدت 8 جلسه به روش حل مسئله گروهی و با استفاده از روش مشارکت آموزشی و تئوری آموزشی بزرگسالان برای گروه مداخله به اجرا در آمد و پس از 6 هفته پایش با گروه کنترل مقایسه شد.
    #2
    Nonintervention for control group
    Conducting the pre-test by completing the demographic information questionnaire, the Iranian version of the quality of life index questionnaire for skin patients (DLOQI), the quality of life questionnaire (SF-36), the family specific questionnaire of skin patients (FDLOQI), the Iranian version of the Walker and Pender lifestyle questionnaire, Questionnaire for measuring the patient's ability and questionnaire for measuring the ability of the active family member by the patient and the active family member and conducting post-test 6 weeks after the completion of the intervention in the intervention group by re-completing the main tools for measuring lifestyle and quality of life by the patient and active family member.
    برای گروه کنترل بدون مداخله
    انجام پیش آزمون از طریق تکمیل پرسشنامه اطلاعات جمعیت شناختی، نسخه ایرانی پرسشنامه شاخص کیفیت زندگی بیماران پوستی ((DLOQI، پرسشنامه کیفیت زندگی(SF-36)، پرسشنامه اختصاصی خانواده بیماران پوستی ((FDLOQI، نسخه ایرانی پرسشنامه سبک زندگی واکر و پندر، پرسشنامه سنجش توانمندی بیمار و پرسشنامه سنجش توانمندی عضو فعال خانواده توسط بیمار و عضو فعال خانواده و انجام پس آزمون 6 هفته پس از اتمام مداخله در گروه مداخله با تکمیل مجدد ابزار های اصلی سنجش سبک زندگی و کیفیت زندگی توسط بیمار وعضو فعال خانواده.
  • Recruitment centers

    #1
    Name of recruitment center - English: Razi Hospital
    Name of recruitment center - Persian: بیمارستان پوست رازی
    Full name of responsible person - English: Maryam Danshpazhooh
    Full name of responsible person - Persian: سرکار خانم دکتر مریم دانش پژوه
    Street address - English: 1199663911, Razi Hospital, Vahdat-e-Islami St., Vahdat-e-Islami Sq., Tehran Province, Tehran District 12, Tehran, IR.Iran
    Street address - Persian: تهران، خ وحدت اسلامی، میدان وحدت اسلامی، بیمارستان پوست رازی، کد پستی ۱۱۹۹۶۶۳۹۱۱
    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: Razi Hospital
    Name of recruitment center - Persian: بیمارستان پوست رازی
    Full name of responsible person - English: Maryam Danshpazhooh
    Full name of responsible person - Persian: مریم دانش پژوه
    Street address - English: 1199663911, Razi Hospital, Vahdat-e-Islami St., Vahdat-e-Islami Sq., Tehran Province, Tehran District 12, Tehran, IR.Iran
    Street address - Persian: تهران، خ وحدت اسلامی، میدان وحدت اسلامی، بیمارستان پوست رازی، کد پستی ۱۱۹۹۶۶۳۹۱۱
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1199663911
    Phone: +98 21 5563 0853
    Fax: +98 21 5562 0300
    Email: maryamdansh@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice chancellor for research, Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: yaghoob Fatolahi
    Full name of responsible person - Persian: جناب آقای دکتر یعقوب فتح‌الهی
    Street address - English: 14115-116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
    Street address - Persian: تهران، جلال آل احمد، پل نصر، دانشگاه تربیت مدرس، کد پستی 14115-116
    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, Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: yaghoob Fatolahi
    Full name of responsible person - Persian: جناب آقای دکتر یعقوب فتح‌الهی
    Street address - English: 14115-116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
    Street address - Persian: تهران، جلال آل احمد، پل نصر، دانشگاه تربیت مدرس، کد پستی 14115-116
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 14115-116
    Phone: +98 21 8288 2009
    Fax: +98 21 8800 6544
    Email: fatolahi@modares.ac.ir
    Web page address: http://www.modares.ac.ir
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    Public
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    Domestic
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    Academic
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Fatemah Alhani
    Full name of responsible person - Persian: سرکار خانم دکتر فاطمه الحانی
    Position - English: PH.D of Health education/ Associate Professor
    Position - Persian: دکتری آموزش بهداشت / دانشیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 14115-116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
    Street address - Persian: تهران، جلال آل احمد، پل نصر، دانشگاه تربیت مدرس، کد پستی 14115-116
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 14115-116
    Phone: +98 21 8288 3898
    Mobile: +98 912 349 5476
    Fax: +98 21 8288 3898
    Email: alhani_f@modares.ac.ir; pres@modares.ac.ir
    Web page address: http://www.modares.ac.ir
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Fatemah Alhani
    Full name of responsible person - Persian: سرکار خانم دکتر فاطمه الحانی
    Position - English: PH.D of Health education/ Associate Professor
    Position - Persian: دکتری آموزش بهداشت / دانشیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 1411713116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
    Street address - Persian: تهران، جلال آل احمد، پل نصر، دانشگاه تربیت مدرس، کد پستی1411713116
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1411713116
    Phone: +98 21 8288 3898
    Mobile: +98 912 349 5476
    Fax: +98 21 8288 3898
    Email: alhani_f@modares.ac.ir
    Web page address: http://www.modares.ac.ir
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Fatemah Alhani
    Full name of responsible person - Persian: سرکار خانم دکتر فاطمه الحانی
    Position - English: PH.D of Health education/ Associate Professor
    Position - Persian: دکترای آموزش بهداشت / دانشیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 14115-116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
    Street address - Persian: تهران، جلال آل احمد، پل نصر، دانشگاه تربیت مدرس، کد پستی 14115-116
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 14115-116
    Phone: +98 21 8288 3898
    Mobile: +98 912 349 5476
    Fax: +98 21 8288 3898
    Email: alhani_f@modares.ac.ir; pres@modares.ac.ir
    Web page address: http://www.modares.ac.ir
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Fatemah Alhani
    Full name of responsible person - Persian: سرکار خانم دکتر فاطمه الحانی
    Position - English: PH.D of Health education/ Associate Professor
    Position - Persian: دکترای آموزش بهداشت / دانشیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 1411713116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
    Street address - Persian: تهران، جلال آل احمد، پل نصر، دانشگاه تربیت مدرس، کد پستی 1411713116
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1411713116
    Phone: +98 21 8288 3898
    Mobile: +98 912 349 5476
    Fax: +98 21 8288 3898
    Email: alhani_f@modares.ac.ir
    Web page address: http://www.modares.ac.ir
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Fatemah Alhani
    Full name of responsible person - Persian: سرکار خانم دکتر فاطمه الحانی
    Position - English: PH.D of Health education/ Associate Professor
    Position - Persian: دکتری آموزش بهداشت / دانشیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 14115-116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
    Street address - Persian: تهران، جلال آل احمد، پل نصر، دانشگاه تربیت مدرس، کد پستی 14115-116
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 14115-116
    Phone: +98 21 8288 3898
    Mobile: +98 912 349 5476
    Fax: +98 21 8288 3898
    Email: alhani_f@modares.ac.ir; pres@modares.ac.ir
    Web page address: http://www.modares.ac.ir
    contact.organization_id:
    Name of organization / entity - English: Tarbiat Modares University
    Name of organization / entity - Persian: دانشگاه تربیت مدرس
    Full name of responsible person - English: Fatemah Alhani
    Full name of responsible person - Persian: سرکار خانم دکتر فاطمه الحانی
    Position - English: PH.D of Health education/ Associate Professor
    Position - Persian: دکتری آموزش بهداشت / دانشیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 1411713116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
    Street address - Persian: تهران، جلال آل احمد، پل نصر، دانشگاه تربیت مدرس، کد پستی 1411713116
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1411713116
    Phone: +98 21 8288 3898
    Mobile: +98 912 349 5476
    Fax: +98 21 8288 3898
    Email: alhani_f@modares.ac.ir
    Web page address: http://www.modares.ac.ir
  • Sharing plan

    undecided
    undecided
    na
    undecided
    undecided
    na
    undecided
    empty
    There is no more information.
    empty
    اطلاعات بیشتری وجود ندارد.

Protocol summary

Study aim
Health services
Design
matched controlled clinical trial study; parallel group; No blinding; Simple randomization using lottery.
Settings and conduct
This matched controlled clinical trial study was conducted by Purposive sampling 72 female patients with Pemphigus Vulgaris and 72 active family members and through random allocation was divided into two groups: intervention and control. Data were collected by demographic, specialty instrument of empowerment of patients and specialty instrument of active family members questionnaires, Lifestyle (HPLP II) and SF-36 for patients and active family members , dermatology life quality index, the family Dermatology life quality index (FDLQI) questionnaires. FCEM implemented in steps (perceived threat, self-efficacy, self-esteem and evaluations) for the intervention group. Usual care was done for control group. After 6 weeks, was compared with the control. Data was analyzed by statistical software SPSS V.24, and rate (P <0.05) was considered significant.
Participants/Inclusion and exclusion criteria
Inclusion criteria: register Pemphigus Vulgaris in the health case; Patients' and active family member's satisfaction ; Ability to communicate; No mental illness or other acute or chronic illness; Not a member of health team and having at least literacy. Exclusion criteria: the patient and active family member's unwillingness to continue; patient has an acute or chronic illness; the patient has a mental illness; Patient or active family member death.
Intervention groups
female patients with Pemphigus Vulgaris and active family member in two groups of intervention and control.
Main outcome variables
Quality of public and Exclusive life of female patients with Pemphigus Vulgaris and active family member.

General information

Reason for update
Add primary and secondary outcome variable
Acronym
-
IRCT registration information
IRCT registration number: IRCT2017061934632N1
Registration date: 2017-08-16, 1396/05/25
Registration timing: retrospective

Last update: 2022-08-07, 1401/05/16
Update count: 1
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Maryam Ghasemi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 6646 7688
Email address
maryamghasemi254@gmail.com
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
2017-09-23, 1396/07/01
Scientific title
comparison of the effect of family-centered empowerment model based lifestyle modification on quality of life of female patients with Pemphigus Vulgaris and active family member in the intervention group with no implementation of the model in patients and active family member in the control group.
Public title
Family-centered empowerment model for enhance quality of life of female patients with Pemphigus Vulgaris and active family member.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
register Pemphigus Vulgaris according to the doctor's diagnosis in the health case women aged 30-60 years Patients' and active family member's desire and satisfaction to participate in the research; Ability to communicate verbally ; provide information and collaborate with the researcher No mental illness or other acute or chronic illness Not a member of the health team having at least literacy to complete the Questionnaire
Exclusion criteria:
the patient and active family member's unwillingness to continue to participate in research the patient has an acute or chronic illness the patient has a mental illness Patient or active family member death
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
Actual sample size reached: 144
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the research samples were selected by the researcher using the purposeful sampling method by studying the patients' files to reach the qualified patients more precisely, according to the entry criteria and after assimilation by one of the nurses based on the criteria of age, type of disease, severity of the disease and duration of the disease, the block was randomly assigned and then, using the Minimization method, the samples were homogenized by SPSS software and by using lottery and randomly, the research samples were placed in one of the control or intervention groups.
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 Tarbiat Modares University
Street address
14115-116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
City
Tehran
Province
Tehran
Postal code
14115-116
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.TMU.REC.1395.404

Health conditions studied

1

Description of health condition studied
Pemphigus Vulgaris
ICD-10 code
L10.0
ICD-10 code description
Pemphigus vulgaris

Primary outcomes

1

Description
lifestyle
Timepoint
Before intervention- two months after the end of the intervention
Method of measurement
Walker- Pender health-promoting Lifestyle Questionnaire

Secondary outcomes

1

Description
Quality of public life of female patients with Pemphigus Vulgaris and active family member
Timepoint
Before intervention; two months after the end of the intervention
Method of measurement
SF-36 quality of life Questionnaire

2

Description
Quality of Exclusive life of female patients with Pemphigus Vulgaris
Timepoint
Before intervention; two months after the end of the intervention
Method of measurement
Iranian version dermatology life quality index (DLQI)

3

Description
Quality of exclusive life of active family member.
Timepoint
Before intervention; two months after the end of the intervention.
Method of measurement
The family dermatology life quality index (FDLQI).

Intervention groups

1

Description
After analyzing the data before the intervention, which led to the identification of the resources, limitations, needs and strengths of the patient and his active family member in different fields, Changes were made in the previously designed empowerment program for these patients, so that the implementation of the empowerment model fits the needs and demands of the research samples. After the pre-test, the intervention phase began and since this study was conducted as an intervention and control; The intervention phase was performed only for the intervention group and the control group did not receive any intervention. In the intervention group, the family-centered empowerment model in executive steps (understanding the threat, internalizing the axis of control, self-efficacy, self-belief, self-control, follow-up and evaluation) for 8 sessions by group problem solving method and using educational participation method and adult educational theory for The intervention group was implemented and after 6 weeks, were compared with the control group.
Category
Lifestyle

2

Description
Conducting the pre-test by completing the demographic information questionnaire, the Iranian version of the quality of life index questionnaire for skin patients (DLOQI), the quality of life questionnaire (SF-36), the family specific questionnaire of skin patients (FDLOQI), the Iranian version of the Walker and Pender lifestyle questionnaire, Questionnaire for measuring the patient's ability and questionnaire for measuring the ability of the active family member by the patient and the active family member and conducting post-test 6 weeks after the completion of the intervention in the intervention group by re-completing the main tools for measuring lifestyle and quality of life by the patient and active family member.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Maryam Danshpazhooh
Street address
1199663911, Razi Hospital, Vahdat-e-Islami St., Vahdat-e-Islami Sq., Tehran Province, Tehran District 12, Tehran, IR.Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0853
Fax
+98 21 5562 0300
Email
maryamdansh@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tarbiat Modares University
Full name of responsible person
yaghoob Fatolahi
Street address
14115-116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
City
Tehran
Province
Tehran
Postal code
14115-116
Phone
+98 21 8288 2009
Fax
+98 21 8800 6544
Email
fatolahi@modares.ac.ir
Web page address
http://www.modares.ac.ir
Grant name
121000
Grant code / Reference number
52د/8712
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Fatemah Alhani
Position
PH.D of Health education/ Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
1411713116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3898
Fax
+98 21 8288 3898
Email
alhani_f@modares.ac.ir
Web page address
http://www.modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemah Alhani
Position
PH.D of Health education/ Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
1411713116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3898
Fax
+98 21 8288 3898
Email
alhani_f@modares.ac.ir
Web page address
http://www.modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemah Alhani
Position
PH.D of Health education/ Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
1411713116, No.7, Tarbiat Modares University, Jalal All Ahmad Street, Tehran, IR. Iran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3898
Fax
+98 21 8288 3898
Email
alhani_f@modares.ac.ir
Web page address
http://www.modares.ac.ir

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
Not applicable
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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