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Effect of education based on the Common-Sense Model of Self-Regulation on illness perception among elderly patients with hypertension: A Randomized Controlled Clinical Trial

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History
# Registration date Revision Id
2 2025-01-03, 1403/10/14 326180
1 2024-03-24, 1403/01/05 297864
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  • General information

    empty
    Changes in inclusion criteria to reach the required sample size
    empty
    تغییرات معیارهای ورود برای رسیدن به حجم نمونه لازم
    Patients must be 18 years old or older.
    Having high blood pressure according to the diagnosis of a cardiologist
    Regular daily use of at least one antihypertensive drug for at least 3 months
    Able to cooperate to complete the questionnaire and carry out the intervention
    Patients must be 60 years old or older.
    a confirmed diagnosis of primary hypertension classified as either stage 1 or stage 2
    A minimum duration of hypertension of six months
    Provision of informed consent to participate.
    بیماران 60سال و بالاتر سن داشته باشند.
    مبتلا بودن فشارخون نوع اولیه طبق تشخیص پزشک کاردیولوژیست
    مصرف منظم روزانه حداقل یک داروی ضد فشارخون برای حداقل 3 ماه
    قادر به همکاری جهت تکمیل پرسشنامه و انجام
    بیماران 60سال و بالاتر سن داشته باشند.
    تشخیص تایید شده فشار خون اولیه طبقه بندی شده به عنوان مرحله 1 یا مرحله 2
    حداقل مدت فشار خون بالا شش ماه
    انجام و ارائه رضایت آگاهانه برای شرکت
    suffering from complications due to blood pressure
    bsence more than once in training sessions
    Unwillingness to participate in the study
    Participation in similar educational and research projects during the course of study
    patients' refusal to participate
    Absence of other chronic diseases or severe complications related to hypertension.
    ابتلا به عوارض ناشی از فشارخون
    غیبت بیش از یک بار در جلسات آموزشی
    عدم تمایل برای شرکت درمطالعه شرکت
    شرکت در پروژه‌های آموزشی و تحقیقاتی مشابه در طول مطالعه
    امتناع بیماران از مشارکت .
    عدم وجود سایر بیماری های مزمن یا عوارض شدید مرتبط با فشار خون بالا.

  • Primary outcomes

    #1
    Before the intervention, immediately after the intervention and one month later
    Before the intervention and the eighth week after the start of the intervention
    قبل از مداخله، بلافاصله بعد از مداخله و یکماه بعد
    قبل از مداخله و 8 هفته بعد از شروع مداخله

  • Recruitment centers

    #1
    Name of recruitment center - English: مراکز سلامت جامعه وابسته به دانشکده علوم پزشکی لارستان
    Name of recruitment center - Persian: Community health centers affiliated to Larestan University of Medical Sciences
    Full name of responsible person - English: Ali Mohammad Parviniannasab
    Full name of responsible person - Persian: علی محمد پروینیان نسب
    Street address - English: Dadman Blvd
    Street address - Persian: بلوار دادمان
    City - English: Larestan
    City - Persian: لارستان
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 74319-75566
    Phone: +98 71 5224 7110
    Fax:
    Email: ali_parviniyan@yahoo.com
    Web page address:
    Name of recruitment center - English: Community health centers affiliated to Larestan University of Medical Sciences
    Name of recruitment center - Persian: مراکز سلامت جامعه وابسته به دانشکده علوم پزشکی لارستان
    Full name of responsible person - English: Ali Mohammad Parviniannasab
    Full name of responsible person - Persian: علی محمد پروینیان نسب
    Street address - English: Dadman Blvd
    Street address - Persian: بلوار دادمان
    City - English: Larestan
    City - Persian: لارستان
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 74319-75566
    Phone: +98 71 5224 7110
    Fax:
    Email: ali_parviniyan@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: محسن سلمان پور
    Full name of responsible person - Persian: Mohsen Salmanpor
    Street address - English: Imam Khomeini Square, Velayat Blvd
    Street address - Persian: میدان امام خمینی ، بلوار ولایت
    City - English: Larestan
    City - Persian: لارستان
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 74319-75566
    Phone: +98 71 5224 7110
    Fax:
    Email: ali_parviniyan@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohsen Salmanpor
    Full name of responsible person - Persian: محسن سلمان پور
    Street address - English: Imam Khomeini Square, Velayat Blvd
    Street address - Persian: میدان امام خمینی ، بلوار ولایت
    City - English: Larestan
    City - Persian: لارستان
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 74319-75566
    Phone: +98 71 5224 7110
    Fax:
    Email: ali_parviniyan@yahoo.com
    Web page address:

Protocol summary

Study aim
Determining the effect of education based on the Common-Sense Model of Self-Regulation on illness perception among elderly patients with hypertension: A Randomized Controlled Clinical Trial
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized on 62 patients with hypertension in the elderly with a one-month follow-up.
Settings and conduct
The present study will be conducted on elderly people with primary hypertension referring to health centers affiliated to Larestan University of Medical Sciences
Participants/Inclusion and exclusion criteria
suffering from complications due to blood pressure and absence more than once in training sessions Unwillingness to participate in the study Participation in similar educational and research projects during the course of study
Intervention groups
Receive 5 training sessions based on common sense self-regulation model. The researcher interacted with the patients and explained the objectives of the study and assessed the patient's understanding of the nature, causes, symptoms and management of hypertension. A researcher asked the patient the following questions: What is high blood pressure? What is its normal range? What are the causes of high blood pressure? Which causes are controllable and which are uncontrollable? What do you do to manage and control your blood pressure?
Main outcome variables
The score of Broadbent's illness perception

General information

Reason for update
Changes in inclusion criteria to reach the required sample size
Acronym
IRCT registration information
IRCT registration number: IRCT20240122060771N2
Registration date: 2024-03-24, 1403/01/05
Registration timing: registered_while_recruiting

Last update: 2025-01-05, 1403/10/16
Update count: 1
Registration date
2024-03-24, 1403/01/05
Registrant information
Name
Ali Mohammad Parviniannasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5224 7110
Email address
ali_parviniyan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on the Common-Sense Model of Self-Regulation on illness perception among elderly patients with hypertension: A Randomized Controlled Clinical Trial
Public title
Effect of education based on the Model of Self-Regulation on illness perception among elderly patients with hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must be 60 years old or older. a confirmed diagnosis of primary hypertension classified as either stage 1 or stage 2 A minimum duration of hypertension of six months Provision of informed consent to participate.
Exclusion criteria:
patients' refusal to participate Absence of other chronic diseases or severe complications related to hypertension.
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of 30 people based on regular allocation technique. First, as a simple randomization, the first referring patient takes the word "control" or "intervention" from the sealed envelope and is placed in the desired group, and with this method, concealment is done for the patient. The patient will be placed in the opposite group at the next visit. Other subsequent patients will be placed equally in the intervention and control groups. The unit of randomization is the patient and the construction method is a random sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the nature of the intervention, which is educational, it is not possible to blind the participants, but the help of the researcher who collects the data and the person who performs the statistical analysis will not know determine which of the intervention and control groups the patients are placed in.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Larestan Faculty of Medical Sciences
Street address
Imam Khomeini Square, Velayat Blvd
City
Larestan
Province
Fars
Postal code
74319-75566
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.LARUMS.REC.1402.032

Health conditions studied

1

Description of health condition studied
Elderly with primary hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Bradbent's illness perception
Timepoint
Before the intervention and the eighth week after the start of the intervention
Method of measurement
illness perception questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention framework in this study is based on the self-regulation model of common sense(35) and the educational content will be based on the 5 dimensions of disease perception and also the effect that this model can have on the understanding of patients' disease. These dimensions include: the nature (label and symptoms of the disease), the person's belief or reason about the causes of the onset of the disease, the duration or the person's perception of the duration of the disease, the expected consequences of the person or the findings of the disease, and the effectiveness of control and recovery. Then, the patients of the intervention group are subjected to the educational program designed based on the disease understanding model for a specified period (5 weeks - one session per week). Then, immediately after the end of the intervention, the abbreviated disease perception questionnaire will be provided to the study samples (after the last session of the intervention). Sessions will last between 45 and 60 minutes. Therefore, the main content of the educational program will be the same for everyone, but according to the respondents' answers to the 5 factors of the disease understanding model, the emphasis and priority of education on these concepts will be different for each patient. The educational content collected by the research team members will be approved and evaluated by a karyologist and 2 nurse experts. At the end of each session, the educational content will be provided to the samples in the form of an educational pamphlet.
Category
Treatment - Other

2

Description
Control group: Patients who receive only the usual training and procedures of the center.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Community health centers affiliated to Larestan University of Medical Sciences
Full name of responsible person
Ali Mohammad Parviniannasab
Street address
Dadman Blvd
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5224 7110
Email
ali_parviniyan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Mohsen Salmanpor
Street address
Imam Khomeini Square, Velayat Blvd
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5224 7110
Email
ali_parviniyan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Larestan 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
Larestan University of Medical Sciences
Full name of responsible person
Ali Mohammad Parviniannasab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Square, Velayat Blvd
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5224 7110
Email
ali_parviniyan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Ali Mohammad Parviniannasab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Square, Velayat Blvd
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5224 7110
Email
ali_parviniyan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Larestan University of Medical Sciences
Full name of responsible person
Ali Mohammad Parviniannasab
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Square, Velayat Blvd
City
Larestan
Province
Fars
Postal code
74319-75566
Phone
+98 71 5224 7110
Email
ali_parviniyan@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It can be shared after de-identifying people
When the data will become available and for how long
Access starts one year after results are published
To whom data/document is available
People working in academic and scientific institutions
Under which criteria data/document could be used
Subject to the agreement of Larestan Faculty of Medical Sciences
From where data/document is obtainable
Dr. Ali Mohammad Parviniyan Nesab, assistant professor of Larestan Faculty of Medical Sciences, email address: ali_parviniyan@yahoo.com, phone number: 07152255278, mobile number: 09171492744
What processes are involved for a request to access data/document
A written and official request to the Research Vice-Chancellor of Larestan Faculty of Medical Sciences
Comments
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