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The effect of peer-based virtual education on cardiac self-efficacy and self-care of patients with heart failure

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History
# Registration date Revision Id
2 2025-03-08, 1403/12/18 333276
1 2024-08-11, 1403/05/21 311148
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  • Protocol summary

    Clinical trial with control group, with parallel group, randomized, sample size 74 patients
    A randomized, parallel-group, controlled clinical trial with a sample size of 74 people. First, patients who meet the inclusion criteria will be selected on a convenience basis. Then, they will be randomly assigned to two groups using sealed opaque envelopes.
    کارآزمایی بالینی دارای گروه کنترل، با گروه موازی،تصادفی شده، حجم نمونه 74 بیمار
    کارآزمایی بالینی دارای گروه کنترل، با گروه موازی، تصادفی شده، حجم نمونه 74 نفر، ابتدا بیمارانی که دارای معیارهای ورود به مطالعه باشند به صورت در دسترس انتخاب می شوند. سپس با استفاده از پاكت نامه های غيرشفاف مهر و موم شده با توالی تصادفی به دو گروه تخصیص داده خواهند شد.
    Sampling is done in Farshchian Heart Center of Hamadan city, among the patients with heart failure. The test group will be trained in self-care behaviors during eight sessions. These trainings will be online for one month. The control group will not receive any training until the end of the study. Data are collected from both groups using the demographic and self-care questionnaire of heart failure disease and cardiac self-efficacy, before and one month after the intervention.
    Sampling is done in Farshchian Heart Center of Hamadan city, among the patients with heart failure. The test group will be trained in self-care behaviors during eight sessions. These trainings will be online for one month. The control group will not receive any training until the end of the study. Data are collected from both groups using the demographic and self-care questionnaire of heart failure disease and cardiac self-efficacy, before and one month after the intervention, 6 months and one year after the intervention.
    نمونه گیری در مرکز قلب فرشچیان شهرستان همدان، از بین مبتلایان به نارسایی قلبی انجام می شود. گروه آزمون در طی هشت جلسه تحت آموزش رفتارهای خودمراقبتی قرار خواهند گرفت. این آموزش های طی یک ماه در فضای مجازی خواهند بود. گروه کنترل هیچ گونه آموزشی تا پایان مطالعه دریافت نخواهند کرد. داده ها با استفاده از پرسشنامه دموگرافیک و خودمراقبتی بیماری نارسایی قلبی و خودکارآمدی قلبی، قبل و یک ماه بعد از مداخله از هر دو گروه جمع آوری می شود.
    نمونه گیری در مرکز قلب فرشچیان شهرستان همدان، از بین مبتلایان به نارسایی قلبی انجام می شود. گروه آزمون در طی هشت جلسه تحت آموزش رفتارهای خودمراقبتی قرار خواهند گرفت. این آموزش های طی یک ماه در فضای مجازی خواهند بود. گروه کنترل هیچ گونه آموزشی تا پایان مطالعه دریافت نخواهند کرد. داده ها با استفاده از پرسشنامه دموگرافیک و خودمراقبتی بیماری نارسایی قلبی و خودکارآمدی قلبی، قبل از مداخله و یک ماه بعد از مداخله از هر دو گروه جمع آوری می شود. و همچنین پیگیری درازمدت در شش ماه و یک سال بعد مداخله انجام خواهد شد.
    مطالب آموزشی که توسط همتایان بیان و ضبط شده اند طی هشت جلسه از طریق فضای مجازی( پیام رسان ایتا و واتس اپ) در طی یک ماه در اختیار گروه مداخله قرار خواهد گرفت. گروه کنترل فقط آموزشهای روتین حین ترخیص را دریافت میکنند.
    مطالب آموزشی که توسط همتایان بیان و ضبط شده اند طی هشت جلسه از طریق فضای مجازی (پیام رسان ایتا و واتس اپ) در طی یک ماه در اختیار گروه مداخله قرار خواهد گرفت. گروه کنترل فقط آموزشهای روتین حین ترخیص را دریافت میکنند.

  • General information

    empty
    Given that changing self-care behaviors and improving self-efficacy require time, and the learning and institutionalization of these behaviors will change significantly over time, we plan to examine and compare the research variables over a long period of time.
    empty
    با توجه به اینکه تغییر رفتارهای خودمراقبتی و همچنین ارتقای خودکارآمدی نیازمند گذر زمان می باشد و یادگیری و نهادینه شدن این رفتارها با گذشت زمان تغییرات قابل توجهی خواهد داشت، تصمیم داریم تا متغیر های پژوهش را در یک بازه بلند مدت نیز مورد بررسی و مقایسه قرار دهیم.
    سواد خواندن و نوشتن
    تشخیص نارسایی قلبی تأیید شده توسط متخصص قلب و عروق
    سواد استفاده از رسانه های اجتماعی
    داشتن امکانات و توانایی پاسخ به تلفن ( بیمار یا عضو فعال خانواده بیمار)
    نداشتن تشخیص پزشکی افسردگی یا اضطراب
    نداشتن سابقه اختلالات روانی براساس پرونده بیمار و مشکلات گفتاری، شنیداری و نقص شناختی و حافظه
    عضویت در شبکه های مجازی در تلفن همراه ( بیمار یا عضو فعال خانواده بیمار) جهت دریافت آموزش ها
    سن بین 35 تا 70
    سواد خواندن و نوشتن
    تشخیص نارسایی قلبی تأیید شده توسط متخصص قلب و عروق
    سواد استفاده از رسانه های اجتماعی
    داشتن امکانات و توانایی پاسخ به تلفن (بیمار یا عضو فعال خانواده بیمار)
    نداشتن تشخیص پزشکی افسردگی یا اضطراب
    نداشتن سابقه اختلالات روانی براساس پرونده بیمار و مشکلات گفتاری، شنیداری و نقص شناختی و حافظه
    عضویت در شبکه های مجازی در تلفن همراه (بیمار یا عضو فعال خانواده بیمار) جهت دریافت آموزش ها
    سن بین 35 تا 70

  • Primary outcomes

    #1
    Self-care in patients with heart failure
    Self-care
    خودمرافبتی بیماران مبتلا به نارسایی قلبی
    خودمراقبتی
    Before and one month after the intervention
    Before and one month after the intervention, 6 months and one year after the intervention
    قبل و یک ماه بعد از مداخله
    قبل و یک ماه بعد از مداخله، شش ماه و یک سال بعد از مداخله

  • Secondary outcomes

    #1
    Before and one month after the intervention
    Before and one month after the intervention, 6 months and one year after the intervention
    قبل و یک ماه بعد از اتمام مداخله
    قبل و یک ماه بعد از اتمام مداخله، شش ماه و یک سال بعد از مداخله

  • Recruitment centers

    #1
    Name of recruitment center - English: Farshchian Heart Hospital in Hameda
    Name of recruitment center - Persian: بیمارستان قلب فرشچیان شهر همدان
    Full name of responsible person - English: Amirhosein sharifi kelarijani
    Full name of responsible person - Persian: امیرحسین شریفی کلاریجانی
    Street address - English: Shahid Fahmideh St., Farshchian Heart Hospital
    Street address - Persian: خیابان شهید فهمیده ، بیمارستان قلب فرشچیان
    City - English: hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838695
    Phone: +98 81 3838 1740
    Fax:
    Email: amirsharifi2486@gmail.com
    Web page address:
    Name of recruitment center - English: Farshchian Heart Hospital in Hamadan
    Name of recruitment center - Persian: بیمارستان قلب فرشچیان شهر همدان
    Full name of responsible person - English: Amirhosein sharifi kelarijani
    Full name of responsible person - Persian: امیرحسین شریفی کلاریجانی
    Street address - English: Shahid Fahmideh St., Farshchian Heart Hospital
    Street address - Persian: خیابان شهید فهمیده ، بیمارستان قلب فرشچیان
    City - English: hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838695
    Phone: +98 81 3838 1740
    Fax:
    Email: amirsharifi2486@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr reza shokouhi
    Full name of responsible person - Persian: دکتر رضا شکوهی
    Street address - English: Shahid Fahmideh St., Farshchian Heart Hospital
    Street address - Persian: خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان
    City - English: hamedan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838695
    Phone: +98 81 3838 0717
    Fax:
    Email: info.research@umsha.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Reza Shokouhi
    Full name of responsible person - Persian: دکتر رضا شکوهی
    Street address - English: Shahid Fahmideh St., Hamadan University of Medical Sciences
    Street address - Persian: خيابان شهيد فهميده، دانشگاه علوم پزشكي همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838695
    Phone: +98 81 3838 0717
    Fax:
    Email: info.research@umsha.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amirhosein sharifi kelarijani
    Full name of responsible person - Persian: امیرحسین شریفی کلاریجانی
    Position - English: nursing student
    Position - Persian: دانشجوی پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hamedan ; Shahid Fahmideh St , Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery
    Street address - Persian: همدان، خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان، دانشکده پرستاری و مامایی
    City - English: hamedan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838695
    Phone: +98 81 3838 0572
    Mobile: +98 933 487 7997
    Fax:
    Email: amirsharifi2486@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Amirhosein sharifi kelarijani
    Full name of responsible person - Persian: امیرحسین شریفی کلاریجانی
    Position - English: nursing student
    Position - Persian: دانشجوی پرستاری
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hamedan ; Shahid Fahmideh St , Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery
    Street address - Persian: همدان، خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان، دانشکده پرستاری و مامایی
    City - English: Hamedan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838695
    Phone: +98 81 3838 0572
    Mobile: +98 933 487 7997
    Fax:
    Email: amirsharifi2486@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Azim azizi
    Full name of responsible person - Persian: دکتر عظیم عزیزی
    Position - English: phd in nursing
    Position - Persian: دکترای پرستاری
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Fahmideh St., Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان، دانشکده پرستاری و مامایی
    City - English: hamedan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838695
    Phone: +98 81 3838 0572
    Mobile: +98 918 107 0758
    Fax:
    Email: azimazizi1360@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Azim azizi
    Full name of responsible person - Persian: دکتر عظیم عزیزی
    Position - English: phd in nursing
    Position - Persian: دکترای پرستاری
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Fahmideh St
    Street address - Persian: خیابان شهید فهمیده
    City - English: hamedan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838695
    Phone: +98 81 3838 0572
    Mobile: +98 918 107 0758
    Fax:
    Email: azimazizi1360@gmail.com
    Web page address:

Protocol summary

Study aim
Determining the impact of peer-based virtual education on cardiac self-efficacy and self-care of patients with heart failure
Design
A randomized, parallel-group, controlled clinical trial with a sample size of 74 people. First, patients who meet the inclusion criteria will be selected on a convenience basis. Then, they will be randomly assigned to two groups using sealed opaque envelopes.
Settings and conduct
Sampling is done in Farshchian Heart Center of Hamadan city, among the patients with heart failure. The test group will be trained in self-care behaviors during eight sessions. These trainings will be online for one month. The control group will not receive any training until the end of the study. Data are collected from both groups using the demographic and self-care questionnaire of heart failure disease and cardiac self-efficacy, before and one month after the intervention, 6 months and one year after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion and Exclusion Criteria: Major Inclusion Criteria Before Randomization: Patients who meet the study's inclusion criteria, which include a diagnosis of heart failure, literacy in using social media, no participation in a similar educational program, and being between 35 and 65 years old, will be selected using convenience sampling. Major Exclusion Criteria Before Randomization: Exclusion criteria include participation in a heart disease educational program within the past 6 months and a diagnosis of psychiatric disorders.
Intervention groups
The educational materials that have been expressed and recorded by the peers will be provided to the intervention group during eight sessions through virtual space (Ita messenger and WhatsApp) within a month. The control group only received routine training during discharge.
Main outcome variables
Selfcare

General information

Reason for update
Given that changing self-care behaviors and improving self-efficacy require time, and the learning and institutionalization of these behaviors will change significantly over time, we plan to examine and compare the research variables over a long period of time.
Acronym
IRCT registration information
IRCT registration number: IRCT20240611062088N1
Registration date: 2024-08-11, 1403/05/21
Registration timing: registered_while_recruiting

Last update: 2025-03-11, 1403/12/21
Update count: 1
Registration date
2024-08-11, 1403/05/21
Registrant information
Name
Amirhosein Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4243 2486
Email address
amirsharifi2486@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peer-based virtual education on cardiac self-efficacy and self-care of patients with heart failure
Public title
The effect of peer-based virtual education on cardiac self-efficacy and self-care of patients with heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy for reading and writing Heart failure diagnosis confirmed by a cardiologist Social media literacy Having the facilities and ability to answer the phone (patient or active member of the patient's family) Not having a medical diagnosis of depression or anxiety Not having a history of mental disorders based on the patient's file and speech and hearing problems and cognitive and memory deficits Membership in virtual networks on a mobile phone (patient or active member of the patient's family) to receive training Age between 35 and 70
Exclusion criteria:
Participation in heart failure training programs in the last 6 months Inability to read and write
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, patients who meet the study's inclusion criteria will be selected using convenience sampling.They will then be randomly assigned to either Group A (the intervention group) or Group B (the control group) using sealed, opaque envelopes. Specifically, 37 cards labeled "A" and 37 cards labeled "B" will be prepared and placed inside the sealed, opaque envelopes. These envelopes will be thoroughly mixed. To allocate patients to Groups A and B, each patient will be asked to randomly select one of the envelopes. Based on the card inside, patients will be assigned to either the test group or the control 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 hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.UMSHA.REC.1403.090

Health conditions studied

1

Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Self-care
Timepoint
Before and one month after the intervention, 6 months and one year after the intervention
Method of measurement
Using a standard self-care questionnaire

Secondary outcomes

1

Description
Self-efficacy of cardiac patients
Timepoint
Before and one month after the intervention, 6 months and one year after the intervention
Method of measurement
Sullivan's standard cardiac self-efficacy questionnaire

Intervention groups

1

Description
Intervention group: Sending educational files recorded by peers via WhatsApp or Eitaa for 15-20 minutes for 8 sessions in one month including: explanation of heart function, recognition of heart disease and its complications, diet and drug management, sodium restriction and Fluids, the importance and method of daily weighing, regular exercise, monitoring signs and symptoms of disease exacerbation, not smoking, social activities, sexual activity, taking medications, following medical orders and avoiding self-medication.
Category
Treatment - Other

2

Description
Control group: Receiving routine trainings during discharge to patients and also receiving educational video files to patients after the end of the research intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan
Full name of responsible person
Amirhosein sharifi kelarijani
Street address
Shahid Fahmideh St., Farshchian Heart Hospital
City
hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
amirsharifi2486@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokouhi
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Amirhosein sharifi kelarijani
Position
nursing student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hamedan ; Shahid Fahmideh St , Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
amirsharifi2486@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azim azizi
Position
phd in nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St
City
hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azimazizi1360@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Amirhosein sharifi kelarijani
Position
nursing student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Faculty of Nursing and Midwifery
City
hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
amirsharifi2486@gmail.com

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
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