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Investigating the Efficacy of a combined training program on Clinical Outcome of Patients with Heart Failure

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History
# Registration date Revision Id
2 2023-06-29, 1402/04/08 269889
1 2023-06-28, 1402/04/07 269795
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  • General information

    empty
    this update has been made regarding the contact information and address of the sampling center and the information related to the person responsible for the clinical trial.
    empty
    این به روز رسانی درمورد اطلاعات تماس و آدرس مرکز نمونه گیری و اطلاعات مربوط به مسئول پاسخگویی به کارآزمایی بالینی صورت گرفته است.

  • Recruitment centers

    #1
    Name of recruitment center - English: Modares Hospital
    Name of recruitment center - Persian: بیمارستان مدرس
    Full name of responsible person - English: Zohreh Shahbazi
    Full name of responsible person - Persian: زهره شهبازی
    Street address - English: Momeni Alley, South Heydari St, Valiasr town
    Street address - Persian: شهرک ولیعصر، خیابان حیدری جنوبی، کوچه مومنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1373916632
    Phone: +98 936 372 5619
    Fax:
    Email: nrszohreshahbazi@gmail.com
    Web page address:
    Name of recruitment center - English: Modares Hospital
    Name of recruitment center - Persian: بیمارستان مدرس
    Full name of responsible person - English: Zohreh Shahbazi
    Full name of responsible person - Persian: زهره شهبازی
    Street address - English: Tehran, Yadgar Imam highway, Saadat Abad interasection
    Street address - Persian: تهران، بزرگراه یادگار امام، تقاطع سعادت آباد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 3438319987
    Phone: +98 21 2207 4087
    Fax:
    Email: nrszohreshahbazi@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: نرجس موسوی زاده
    Full name of responsible person - Persian: Narges mosavizade
    Street address - English: Momeni Alley, South Heydari St, Valiasr Town
    Street address - Persian: شهرک ولیعصر، خیابان حیدری جنوبی، کوچه مومنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1373916632
    Phone: +98 936 372 5619
    Fax:
    Email: nrszohreshahbazi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Afshin Zarghi
    Full name of responsible person - Persian: دکتر افشین زرقی
    Street address - English: Tehran - Shahid Chamran highway, Yemen St. - Shahid Arabi St. - Building No. 2 - 5th floor
    Street address - Persian: تهران - بزرگراه شهید چمران خیابان یــمن - خیابان شهید اعــرابی -ساختمان شماره 2-طبقه پنجم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1373916632
    Phone: +98 21 23871
    Fax:
    Email: info@sbmu.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: Zohreh Shahbazi
    Full name of responsible person - Persian: زهره شهبازی
    Position - English: Nursing student
    Position - Persian: دانشجو پرستاری
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Momeni Alley, South Heydari St, Valiasr town
    Street address - Persian: شهرک ولیعصر، خیابان حیدری جنوبی، کوچه مومنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1373916632
    Phone: +98 936 372 5619
    Mobile: +98 936 372 5619
    Fax:
    Email: nrszohreshahbazi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zohreh Shahbazi
    Full name of responsible person - Persian: زهره شهبازی
    Position - English: Nursing student
    Position - Persian: دانشجو پرستاری
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing, Shahid Beheshti University of Medical Sciences
    Street address - Persian: دانشکده پرستاری دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1996835119
    Phone: 02188655366-70
    Mobile: +98 936 372 5619
    Fax:
    Email: nrszohreshahbazi@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: Zohreh Shahbazi
    Full name of responsible person - Persian: زهره شهبازی
    Position - English: Nursing student
    Position - Persian: دانشجو پرستاری
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Momeni Alley, South Heydari St, Valiasr town
    Street address - Persian: شهرک ولیعصر، خیابان حیدری جنوبی، کوچه مومنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1373916632
    Phone: +98 936 372 5619
    Mobile: +98 936 372 5619
    Fax:
    Email: nrszohreshahbazi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zohreh Shahbazi
    Full name of responsible person - Persian: زهره شهبازی
    Position - English: Nursing student
    Position - Persian: دانشجو پرستاری
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing, Shahid Beheshti University of Medical sciences
    Street address - Persian: دانشکده پرستاری دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1996835119
    Phone: 02188655366-70
    Mobile: +98 936 372 5619
    Fax:
    Email: nrszohreshahbazi@gmail.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zohreh Shahbazi
    Full name of responsible person - Persian: زهره شهبازی
    Position - English: Nursing student
    Position - Persian: دانشجو پرستاری
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Momeni Alley, South Heydari St, Valiasr town
    Street address - Persian: شهرک ولیعصر، خیابان حیدری جنوبی، کوچه مومنی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1373916632
    Phone: +98 936 372 5619
    Mobile: +98 936 372 5619
    Fax:
    Email: nrszohreshahbazi@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zohreh Shahbazi
    Full name of responsible person - Persian: زهره شهبازی
    Position - English: Nursing student
    Position - Persian: دانشجو پرستاری
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing, Shahid Beheshti Univercity of Medical Sciences
    Street address - Persian: دانشکده پرستاری دانشگاه علوم پزشکی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1996835119
    Phone: 02188655366-70
    Mobile: +98 936 372 5619
    Fax:
    Email: nrszohreshahbazi@gmail.com
    Web page address:

Protocol summary

Study aim
Investigating the efficacy of a combined training program on clinical out comes on patients with heart failure in selected teaching hospitals affiliated to Shahid Beheshti University of medical sciences
Design
The study is a single blinded parallel clinical trial the sample size is 136 people and the samples are randomly assigned to two intervention and control groups based on block randomization.
Settings and conduct
A parallel clinical trial study is blinded (data analyzer). The place of study is selected educational hospitals affiliated to Shahid Beheshti University of Medical Sciences. The researcher randomly divides the patients into Intervention and control groups. The clients of the intervention group are trained for 8 weeks through messengers, in addition to providing the necessary group training in the platform of this messenger in relation to various aspects of the disease and treatment the learning assessment of the client is also done. If there is a problem during the review of the feedback, the researcher conducts remote monitoring through a phone call with the participant so that the patient is referred to a doctor if necessary.
Participants/Inclusion and exclusion criteria
Inclusion criteria: class 1 to 3 heart failure patients who have access to a smart phone and internet and have completed the study tool completely and do not suffer from other chronic and major disorders. Exclusion criteria: Facing severe physical problems or death during study, Hospitalization of the patient for any reason or change in treatment process
Intervention groups
the study consist of two intervention and control group. the intervention group will receive training and evaluation by phone and internet for 8 weeks and the control group will only received the routine care.
Main outcome variables
Adherence to treatment, Self care

General information

Reason for update
this update has been made regarding the contact information and address of the sampling center and the information related to the person responsible for the clinical trial.
Acronym
IRCT registration information
IRCT registration number: IRCT20230221057476N1
Registration date: 2023-06-28, 1402/04/07
Registration timing: registered_while_recruiting

Last update: 2023-06-30, 1402/04/09
Update count: 1
Registration date
2023-06-28, 1402/04/07
Registrant information
Name
Zohreh Shahbazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 372 5619
Email address
nrszohreshahbazi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Efficacy of a combined training program on Clinical Outcome of Patients with Heart Failure
Public title
Effectiveness of combined training program in patients with heart failure
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 18 years old of age with confirmation of the diagnosis of heart failure Class 1 to 3 heart failure based on NYHA functional classification Access to a smart phone and the internet and the ability to use it Not suffering from other chronic and major disorders such as cancer, depression, mental disability and vision or hearing problems.
Exclusion criteria:
Facing severe physical problems or death during study Hospitalization of the patient for any reason or change in treatment process
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
it is of random block type into intervention and control groups, the list of blocks was obtained by a statistical consultant. 34 cards are created in random order from 1 to 34, each card contains a combination of 4 in 34 different envelopes. it is transparent. in order to maintain the random sequence the outer surface of the envelopes has been numbered in the same order. in this way after the arrival of each patient according to the block prepared in the previous step the patient is randomly placed in the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
the study was blinded and the data analyst was blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research Shahid Beheshti University of Medical Sciences
Street address
Tehran, Shahid Chahmran Highqway, Yaman St, Arabi St
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-06-22, 1402/04/01
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.247

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
Adherence to treatment
Timepoint
Before the start of the intervention and one month after the end of the intervention.
Method of measurement
Morisky Medication Adherence Scale

2

Description
self care in patients with heart failure
Timepoint
Before the start of the intervention and one month after the end of the intervention.
Method of measurement
European Heart Failure Self-Care Behavior Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For 8 weeks, every week in a group they will receive an educational content related to various aspects of the disease including drug treatment, diet, physical activity, etc on the platform of one of the available mass messengers, but the feedback from the content presented individually will be taken from the patients every week in the same messenger and also questions related to the symptoms experienced related to the disease during the last week will be asked to monitor the health status of the patients so that they can contact the patients if necessary. they should be taken on the phone and their clinical condition will be evaluated so that the patient can be referred to the treatment center if necessary.Patients enter the study at the time of visiting the clinic, and until the next visit, which takes an average of 2 to 3 months, during this time, the researcher does not have face-to-face training. All training communication is done and tracked on a virtual and remote platform.
Category
Lifestyle

2

Description
Control group: during the period of 8 weeks they will not receive any training or follow up either through messengers or through phone calls and they will be visited only if they go to the clinic in person and they will receive the necessary recommendations according to the previous routine at the time of the visit. at the end of the study and after completing the questionnaires all the content taught to the intervention group will be available to the members of the control group as well.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Modares Hospital
Full name of responsible person
Zohreh Shahbazi
Street address
Tehran, Yadgar Imam highway, Saadat Abad interasection
City
Tehran
Province
Tehran
Postal code
3438319987
Phone
+98 21 2207 4087
Email
nrszohreshahbazi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Tehran - Shahid Chamran highway, Yemen St. - Shahid Arabi St. - Building No. 2 - 5th floor
City
Tehran
Province
Tehran
Postal code
1373916632
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Shahbazi
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
02188655366-70
Fax
Email
nrszohreshahbazi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Shahbazi
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahid Beheshti University of Medical sciences
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
02188655366-70
Fax
Email
nrszohreshahbazi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh Shahbazi
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing, Shahid Beheshti Univercity of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
02188655366-70
Fax
Email
nrszohreshahbazi@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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